Below are recent press releases of interest in the pharmaceutical and device areas. Updated weekly.
New, Free Site – Find Qualified Vendors for Your Lab Testing and Scientific Research, Lab/Reg Outsourcing Assignments
Feb. 21, 2011 WASHINGTON DC — Two new websites now live — www.laboratoryretriever.com and www.regulatoryretriever.com — provide regulatory and laboratory professionals with a free resource to locate qualified vendors to fulfill their laboratory testing and scientific research needs, and also lab and regulatory outsourcing assignments.
“We are very pleased to provide to regulatory and laboratory professionals a comprehensive database of outsourcing positions,” stated Joseph Pickett, President. “There is no other resource online that provides such a complete database of very specific laboratory and regulatory classifieds.”
“In a tougher economic environment, finding qualified laboratory and regulatory vendors to conduct short term outsourcing assignments is critical. We believe our new sites, free for the first month, fill a vital niche in the laboratory and regulatory marketplace,” Pickett continued.
Regulatoryretriever.com and Laboratoryretriever.com at launch offer FREE listing and browsing of outsourcing classifieds. All company information will be kept confidential, and will only be released to qualified regulatory and laboratory firms.
Examples of laboratory classifieds submitted so far in February are:
* FDA GMP bioanalytical laboratory needed for full USP Testing: 1) Ethanol abs. 2) Ethanol 96% 3) Acetone 4) alpha-Tocopherol (racemic)
* Bioanalytical Laboratory needed for the study of two compounds on platelet aggregation. In-vitro testing of human blood cells. Platelet aggregation should be induced by collagen and/or arachidonic acid. After incubation with each compound thromboxane level should be assessed. Several concentrations should be examined.
* Preclinical Laboratory needed for preclinical tesing of a SNL model of Kim and Chung (tight ligation of spinal nerves) 2. CCI model of Bennett and Xie (loose ligation of the sciatic nerve) 3 doses + vehicle + standard compound, 10 rats per dose, 2 compounds to be tested
Examples of regulatory classifieds submitted in January are:
* Israel Regulatory Consultant to advise on needed costs and time of registering dental medical devices in Israel. Need qualified agent in Israel to perform registration activities, maintain registration, and to license/allow multiple distributors to use these registrations to sell our products.
* Europe Pharmaceutical Consultant needed for Generation of CTA and regulatory advice for small molecule drug (NCE) in the area of Alzheimer’s disease to enter clinical phase I in Europe in second half of 2011.
* Oncology company needs Registered agent/Regulatory Consultant for EMEA or FDA GMP certification of products
Please submit your free laboratory or regulatory classified today at www.regulatoryretriever.com or www.laboratoryretriever.com.
Hologic Receives FDA Approval for First 3-D Digital Mammography (Breast Tomosynthesis) System
Selenia Dimensions 3-D technology addresses many of the limitations of conventional mammography
BEDFORD, Mass., Feb. 11, 2011 /PRNewswire/ — Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the Company received approval from the U.S. Food and Drug Administration (FDA) for its Selenia Dimensions digital breast tomosynthesis system (Dimensions 3-D).
Mammography systems using conventional 2-D imaging have limitations caused by tissue overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious. Clinical trials using Hologic’s Dimensions 3-D system showed measurable improvement in clinical performance over conventional mammography. These trials also showed significant gains in specificity — the confidence to rule out cancer without recalling the patient for further study — and other benefits including improved lesion and margin visibility and the ability to accurately localize structures in the breast. The combination of measurable improvements in accuracy and detection, and improved sensitivity, makes the Dimensions 3-D system a superior system vs. conventional digital mammography systems.
“We are extremely proud to be the first company to receive FDA approval of a 3-D digital mammography system and to offer women this ground-breaking , superior imaging technology,” said Rob Cascella, President and Chief Executive Officer. “Our Dimensions 3-D takes advantage of all of the benefits of digital mammography and quite simply makes it better with the combination of fast, high quality 3-D breast imaging. We believe tomosynthesis has the potential to change how screening and diagnostic mammography is performed, and over time will prove invaluable to the earliest possible detection of breast cancer and in the reduction of unnecessary diagnostic interventions.”
According to Jay Stein, PhD, Hologic co-founder and Chief Technology Officer, “Tomosynthesis scans can be performed quickly with Dimensions. This means enhanced performance not just for diagnostic problem solving, but in everyday routine screening. Over the next several years we view Dimensions as a platform technology for other imaging modalities to aid in the fight against breast cancer.”
Hologic’s Dimensions 3-D system is available commercially in more than 40 countries including countries in Europe, Latin America and Asia. In North America, commercial systems are already installed in Canada and Mexico.
About Breast Cancer
One in eight American women will develop breast cancer sometime in her lifetime.(1) In 2009, an estimated 192,370 new cases of invasive breast cancer were diagnosed among American women, as well as an estimated 62,280 additional cases of in situ breast cancer.(2) Over 40,000 American women died from breast cancer in 2009. (3) Only lung cancer accounts for more cancer deaths in American women. The stage at which breast cancer is detected influences a woman’s chance of survival. If detected early, the five-year survival rate is 98 percent. (4) At this time, there is no sure way to prevent breast cancer, which is why regular mammograms starting for most women at age 40 are so important.(5)
About the Dimensions 3-D System
The Company’s Dimensions 3-D mammography system is a new method for breast cancer screening and diagnosis. Unlike prior-generation mammography systems which generate two-dimensional images, breast tomosynthesis produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density. Tomosynthesis images are acquired with the breast held briefly in compression. The examination, which includes a 3-D tomosynthesis image in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram at a total exam dose within current FDA guidelines. The 3-D scan results in a stack of thin high-resolution image slices intended to provide clear rendition of structures in the breast and their spatial relationship with the surrounding breast tissue. The images are displayed on a standard diagnostic workstation for review by the radiologist.
Dimensions 3-D software is a purchasable option on existing Selenia Dimensions 2-D systems. Enabling the 3-D capability on a Dimensions 2-D system involves a software key and adjusting a PC-board setting. There is no need for new hardware. Upright stereotactic biopsy and computer-aided detection are already cleared for use on the Company’s 2-D Dimensions systems.
(1) National Cancer Institute Fact Sheet: “Probability of Breast Cancer in American Women”
(2) American Cancer Society: Breast Cancer Facts and Figures 2009-2010. Table 2, page 4
(3) American Cancer Society, Breast Cancer Facts and Figures 2009-2010. Table 2, page 4
(4) American Cancer Society, Breast Cancer Facts and Figures 2009-2010. Table 7, page 9
(5) www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-detection
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic’s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.
Hologic, Dimensions and Selenia, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves known and unknown risks and uncertainties, including statements about Hologic’s Dimensions 3-D mammography system, including the anticipated benefits of that system. The Company cannot assure that the system will achieve the anticipated benefits described herein, or that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Among other things, newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated. The risks and uncertainties included above are not exhaustive. Other factors that could adversely affect the Company’s business and prospects are described in the Company’s filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such data or statements are based.
Contact:
Deborah R. Gordon
Jim Culley
Vice President, Investor Relations
Director of Marketing
Hologic, Inc.
Hologic, Inc.
Tel: 781.999.7716
Tel: 781.999.7583
SOURCE Hologic, Inc.
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FDA Approves First 3-D Mammography Imaging System
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Selenia Dimensions System may boost accuracy in breast cancer detection, diagnosis
SILVER SPRING, Md., Feb. 11, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.
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A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.
The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.
“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.
As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.
While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.
The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.
According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.
The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
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FDA Clears Test to Help Patients With Kidney Transplants
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Test monitors level of a drug that helps prevent kidney rejection
SILVER SPRING, Md., Feb. 11, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.
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Everolimus, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.
Transplant patients are routinely given drugs that suppress the immune system (immunosuppressants) such as a regimen containing everolimus, cyclosporine, basiliximab, and corticosteroids. These drugs help prevent organ rejection, which occurs when the body’s immune system attacks and destroys a transplanted organ.
Some immunosuppressants are associated with toxic side effects that can injure transplanted kidneys. Balancing the levels of immunosuppressants is critical since transplant patients must take these drugs for the rest of their lives.
“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
QMS Everolimus is one of a number of FDA-cleared or -approved tests physicians can use to monitor and manage immunosuppressant levels, including tests for cyclosporine, tacrolimus, and sirolimus. These tests, along with careful monitoring of clinical signs and symptoms of organ rejection, tissue biopsies, and other lab tests, may increase the chance of having a successful transplant and possibly extend the survival of a transplanted kidney.
In addition to other evaluations, Thermofisher, the manufacturer of QMS Everolimus, demonstrated the performance of the test by comparing results from the new test to the results from everolimus reference tests used in the clinical trial of everolimus. When the clinical trial blood samples were tested with QMS Everolimus, the results, on average, were similar to those of the clinical trial reference test.
More than 87,000 patients are awaiting a kidney transplant in the United States, according to the Health Resources and Services Administration’s Organ Procurement and Transplantation Network.
QMS Everolimus is manufactured by Waltham, Mass.-based Thermofisher. Zortress is marketed by East Hanover, N.J.-based Novartis.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
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Sonoma Orthopedic Products® Announces Acquisition of Key NovaLign™ Orthopaedics, Inc. Assets
Acquisition Expands Flexible-to-Rigid Technology Portfolio
SANTA ROSA, Calif., Feb. 11, 2011 /PRNewswire/ — Sonoma Orthopedic Products announced that it has completed the acquisition of certain key assets of NovaLign Orthopaedics, Inc.
The acquired intellectual property, assets, and licenses relate to novel intramedullary designs for least invasive fracture fixation. Complementary to Sonoma’s proprietary WaviBodyâ„¢ Technology, it is another type of flexible-to-rigid science that allows implants to be inserted into bones in a flexible condition and then locked securely to hold fractures in place during healing. The acquired technology will be marketed under the TaperBodyâ„¢ brand. TaperBody implants can be inserted without violating surrounding joints and are especially useful for long bone fractures. Sonoma Orthopedic Products expects to begin rolling out TaperBody products in Q2 of this year.
About Sonoma Orthopedic Products, Inc.
Sonoma Orthopedic Products is a private orthopedic device company specializing in the development and marketing of least invasive, fracture specific implant systems for addressing problematic fractures. Located in Santa Rosa, CA, the company is bringing significant new treatment options to the orthopedic trauma market.
Contact: Glen Coleman, press@sonomaorthopedics.com
SOURCE Sonoma Orthopedic Products, Inc.
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Genentech’s CEO, Ian T. Clark, Named as the Healthcare Businesswomen’s Association’s 2011 Honorable Mentor
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FAIRFIELD, N.J., Feb. 11, 2011 /PRNewswire-USNewswire/ — The Healthcare Businesswomen’s Association (HBA) today announced that it has named Ian T. Clark, Genentech’s chief executive officer and head of North American commercial operations, as its 2011 Honorable Mentor. He will be formally recognized at the 22nd annual “Woman of the Year” (WOTY) Luncheon on Thursday, May 5, 2011 – the premier event of the year for the healthcare community, attended by over 2,000 industry leaders.
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“I am proud of Genentech’s longtime partnership with the Healthcare Businesswomen’s Association,” said Mr. Clark. “I am delighted to be named this year’s Honorable Mentor, and am committed to investing in the advancement of women in our healthcare industry.”
The HBA created the Honorable Mentor award eleven years ago to recognize one individual each year who demonstrates long-term support of the advancement of women in the healthcare industry, has a personal dedication to developing, mentoring and promoting women in the industry, and who has been supportive of the HBA.
“The Healthcare Businesswomen’s Association is pleased to recognize Ian Clark as our 2011 HBA Honorable Mentor, for his dedication to enhancing and accelerating the stature and accomplishments of women in healthcare,” said Deborah Coogan Seltzer, HBA president and life sciences practice member, Spencer Stuart. “Women at all companies would be very fortunate to have a champion like Ian Clark.”
Mr. Clark serves as chief executive officer and head of North American commercial operations at Genentech Inc, a member of the Roche Group, and sits on Genentech’s board of directors. Previously, he was chief marketing officer and head of global product strategy for Roche Pharma and Genentech. In an earlier role, Mr. Clark served as executive vice president of commercial operations at Genentech.
Before joining Genentech in 2003, he served as president of Novartis Canada, overseeing all of its country operations and, prior to this, as chief operating officer for Novartis in the United Kingdom. Mr. Clark worked in vice presidential roles in sales and marketing for sanofi-aventis and Ivax in the United Kingdom and Eastern Europe. He is on the board of directors of the Biotechnology Industry Organization (BIO). Mr. Clark earned a bachelor of science degree in Biological Sciences from Southampton University.
“Ian Clark is a dedicated champion of the advancement of women at Genentech,” said Carol Wells, Genentech’s senior director for commercial leadership and development and president of HBA’s San Francisco Chapter. “Through his leadership, Genentech has initiated an annual Women’s Leadership Summit on current issues for women in business today. With his passion for diversity and action-driven mentoring approach, he is a powerful voice in support of women leaders in general.”
About The HBA
The Healthcare Businesswomen’s Association (HBA; www.hbanet.org) is in its fourth decade as a global not-for-profit organization dedicated to furthering the advancement of women in healthcare worldwide. With 15 chapters and affiliates throughout the U.S. and in Europe, the HBA is headquartered in New Jersey with offices in Philadelphia and Research Triangle Park. The HBA provides educational opportunities for women and men to develop cutting-edge healthcare industry knowledge and leadership skills; recognizes outstanding women and men in the industry; provides opportunities for networking; creates greater visibility for women in the industry; fosters mentoring relationships and serves as a conduit and sponsor for research on career advancement issues. HBA has nearly 6,000 individual members and over 120 Corporate Partners. It is widely recognized as the catalyst for leadership development of women in healthcare worldwide. For more information, visit www.hbanet.org.
SOURCE Healthcare Businesswomen’s Association
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QuickExtenderPro.com Penis Extender Device Engineered for Quick, Safe and Effective Alternative to Penis Enlargement Surgery
NEW YORK, Feb. 11, 2011 /PRNewswire/ — Even with radical advances in medicine and technology emerging all the time, the Quick Extender Pro penile extender system is still the most effective and safest method to penis enlargement, says QuickExtenderPro.com, the leading provider of penis extender devices recommended by medical professionals worldwide.
With the emergence of the penile extender, procedures such as phalloplasty (penis enhancement surgery) are losing their foothold amongst the medical community. The Quick Extender Pro is based on the concept of penile traction. The penis extender works by applying a constant stretch to the penis throughout the day. It is worn discreetly underneath the pants and will not interrupt day-to-day life. There are a variety of programs available requiring as little as one hour a day up to eight hours for those looking for maximum gains.
“The Quick Extender Pro system is the only safe alternative to the costly and dangerous penis enlargement surgery known as phalloplasty,” said a Quick Extender Pro representative. “You can expect your gains to be permanent and you can discontinue use of the device when you are satisfied with your size.”
The Quick Extender Pro system is proven to give the results, safety and the solution men all over the world have been looking for. Based on proven science and backed by thousands of successful trials, the Quick Extender Pro penile extender is the number one alternative to surgery.
The penile traction method has been proven throughout the years and offers many additional benefits, including increased blood circulation resulting in larger and firmer erections within a few days of beginning treatment. In about a month’s time users generally notice an increase in penis size both in length and girth. The results are gradual and will not affect the normal function of the penis. There is no risk to the user and results are guaranteed through a six-month money back policy. The Quick Extender Pro is targeted to adult males and comes in three different packages to accommodate all budgets.
For a limited time Quick Extender Pro is offering a Valentine’s Day Special of an extra 10% off all purchases plus free shipping within the U.S. and Canada. For more information, visit: www.quickextenderpro.com.
Orexigen slashes staff as it ponders an uncertain future
February 10, 2011 — 8:01am ET | By John Carroll
Confronted by an FDA demand that it run a long and pricey cardiovascular study ahead of any formal decision on its application to market a new obesity treatment, Orexigen Therapeutics ($OREX) has started to bunker down, laying off 23 staffers–40 percent of the biotech’s employees–as it tries to map its next steps.
“We continue to believe in the potential of Contrave and look forward to discussions with the FDA,” said Mike Narachi, Orexigen CEO. “Unfortunately, given the near term uncertainty of Contrave approval, we felt it prudent to consolidate and focus our resources.”
Actually, there’s very little near term uncertainty about Contrave’s approval prospects. The FDA ignored an expert panel’s endorsement of the weight drug when the agency recently rejected the marketing application, confounding the San Diego-based biotech with a trial requirement that analysts estimate could take anywhere from one to two years to complete at a cost of $100 million to $200 million. While partnered on the program, Orexigen is on the hook for all trial expenses, spurring considerable speculation about its ability to fund that kind of work.
The FDA’s decision, one in a series of actions that has put the entire field of obesity drug research under a cloud, has spurred some considerable soul searching among researchers trying to fashion a new development strategy that could work with regulators. The San Diego Union-Tribune notes that developers could try to develop treatments that work for smaller, carefully focused patient populations. Others suggest shifting away from the psychological approach toward metabolic pathways. No matter what, though, analysts say that the idea of taking a mass-market weight drug to the FDA with a minimal amount of safety data simply won’t fly.
“The FDA has been really clear,” said 3D Communications’ Jim DiBiasi. “It’s all about safety. When companies come to the market with one year of (clinical trial data), the FDA says that’s not enough.”
Watson Announces Favorable District Court Ruling in Generic Mucinex® Patent Suit
MORRISTOWN, N.J., Feb. 9, 2011 /PRNewswire/ — Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the United States District Court for the Southern District of Florida has ruled that Watson’s generic versions of Mucinex®, Mucinex® D and Mucinex® DM (Guaifenesin, Dextromethorphan HBr/ Guaifenesin, and Pseudoephedrine/Guaifenesin) Extended-Release products, do not infringe U.S. Patent No. 6,372,252 (the “‘252 Patent”).
The Company said it is continuing to seek final FDA approval of the products.
In 2009, Reckitt Benckiser sued Watson Laboratories, Inc. for patent infringement related to the generic versions of Mucinex®. The Mucinex® products had total U.S. sales of approximately $500 million for the twelve months ending December 31, 2010, according to IMS Health and IRI and are indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women’s Health. Watson has operations in many of the world’s established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watson.com.
Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing information as of the date of this release. It is important to note that Watson’s goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson’s current expectations depending upon a number of factors, risks and uncertainties affecting Watson’s business. These factors include, among others, the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing and outcome of any appeal of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers’ facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s annual report on Form 10-K for the year ended December 31,2009 and Watson’s quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Mucinex® is a registered trademark of Reckitt Benckiser, Inc.
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CONTACTS:
Investors:
Patty Eisenhaur
(973) 355-8141
Media:
Charlie Mayr
(973) 355-8483
SOURCE Watson Pharmaceuticals, Inc.
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Lilly CEO Says Industry, Public Policy Must Pave Way For Innovation
Lechleiter Delivers Keynote Address at 2011 Pharma Summit
LONDON, Feb. 10, 2011 /PRNewswire/ — A new approach to research, along with public policies that support medical innovation, will help biopharmaceutical companies address stubborn diseases with potentially devastating personal and financial consequences, such as cancer and Alzheimer’s disease, according to John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company (NYSE: LLY).
Lechleiter made his remarks Thursday in London during a keynote address at The Economist’s 2011 Pharma Summit: Reinventing Pharma for a New Generation. During his talk, Lechleiter said two imperatives are needed to secure the future of the research-based pharmaceutical industry: changing the way companies conduct research, and public policies that promote an environment in which medical innovation can flourish.
The burden of several diseases is soaring in many countries, including the U.K.
According to the Alzheimer’s Research Trust, for instance, more than 800,000 people in the U.K. are directly affected by dementia at a cost of 23 billion pounds Sterling per year.
And yet, just when the world desperately needs more new medicines for diseases like Alzheimer’s, “our industry is taking too long, we’re spending too much, and we’re producing far too little,” Lechleiter told the audience.
Lechleiter said the case for biopharmaceutical research and new medications is compelling. Specifically, he noted that:
* Innovative medicines have proven themselves time and again to be the most effective way to reduce costs and improve quality in health care.
* Treatments for diseases that remain unconquered, like cancer and Alzheimer’s, most likely will come from laboratories of biopharmaceutical companies.
* Even diseases that are being treated today, like diabetes, require better solutions.
“Ironically, the crisis in our innovation model comes at a time when we have vastly more scientific knowledge and data than ever before,” Lechleiter said. “But unless we change the way we do research, we won’t translate this knowledge into advances for patients. In the face of diminishing results, we can’t simply perform the same old rituals and hope for a different outcome.”
Specifically, Lechleiter stressed the need for research-based pharmaceutical companies to be more networked, global, and entrepreneurial to bring innovative medicines to patients faster and at lower costs. Such a global network is enabling Lilly to strengthen its own R&D capabilities, while attracting molecules, funding, and expertise from partners – creating shared investment, risk, and reward, along with greater efficiencies.
Lechleiter said the new approach to research will be successful only if matched with regulations that support an environment of innovation.
“Even as we rebuild our R&D engine, we must build an environment where pharmaceutical innovation can thrive,” he said. “As pressures on health care systems around the world continue to grow, we will continue to make the case that innovation is imperative, and to advocate for reforms that promote innovation rather than penalize it.”
Currently, government leaders in the U.K. are debating health care reform options to ease the stress on tightening budgets. Lechleiter said the new approach to research will be successful only if matched with regulations that support an environment of innovation.
Biopharmaceutical research, Lechleiter said, has also preserved jobs in the U.K. and other developed countries. In the U.K., there are 72,000 direct jobs in the biopharmaceutical sector and 200,000 indirect jobs. At 12 million pounds each day, the biopharmaceutical industry invests more in R&D than any other sector in the U.K.
Equally important have been the medical advances: in the U.K. alone, average life expectancy increased by 30 years from 1901 to 1999.
“Indeed, encouraging medical innovation needs to be a key purpose of health care reforms in both the United States and the United Kingdom,” Lechleiter said. “We must continually make the case for innovation through our words, but more importantly, through our actions and the value we bring to patients through innovative medicines.”
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. C-LLY
Cell Medica Announces First Patient Treated in Cytomegalovirus~ACE/ASPECT Clinical Trial
LONDON, February 10, 2011 /PRNewswire/ —
– Leading Collaboration Between Cell Medica, Leukaemia & Lymphoma Research, University of Birmingham and NHS Blood and Transplant
Cell Medica, a leading UK cellular therapeutics company that develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, announces today that the first patient has been treated in the CMV~ACE/ASPECT trial at University College Hospital London. The Phase II randomised clinical trial is designed to demonstrate the efficacy of adoptive cellular therapy for the pre-emptive treatment of cytomegalovirus (CMV) infections in patients who have received a bone marrow transplant from an unrelated donor.
Adoptive cellular therapy has been shown to prevent viral diseases in patients post allogeneic haematopoietic stem cell (bone marrow) transplant[1,2]. These patients, typically leukaemia or lymphoma patients, have profoundly compromised immune systems and are at high risk of the reactivation of latent CMV infection, often manifesting as interstitial pneumonitis. CMV serostatus continues to be a risk factor which influences the survival outcome of bone marrow transplant patients and improving the treatment of CMV infections represents an important clinical need[3,4]. Patients undergoing bone marrow transplant from an unrelated donor are at particularly high risk of infection and efficacy in this patient group will add significantly to the market potential of the cell therapy.
The trial represents an important collaboration between leading players from industry, the charitable sector, academic research and the National Health Service with the shared aim of establishing adoptive cellular therapy as routine clinical practice for the treatment of patients at high risk of CMV infection following a bone marrow transplant.
Cell Medica is sponsoring the study and providing the majority of the cell therapy products for the patients being treated. Cell Medica is commercialising a proprietary form of the cell therapy referred to as Cytovir CMV.
Leukaemia & Lymphoma Research is a UK charity dedicated to research into blood cancers including leukaemia, lymphoma and myeloma. The charity is funding certain aspects of the trial.
The University of Birmingham is a research-intensive University and haematology expert Professor Paul Moss, Head of Cancer Sciences, has been pioneering the development of cellular immunotherapy.
NHS Blood and Transplant (NHSBT) is a Special Health Authority within the NHS with responsibility for optimising the supply of blood, organs and tissues and raising the quality, effectiveness and efficiency of blood and transplant services. NHSBT is providing the cell therapy products for two of the participating hospitals and analysing blood samples to determine patient responses to the treatment within this trial.
Trial Design
The CMV~ACE/ASPECT is a randomised, controlled study and will include 36 patients across ten UK hospitals. Patients in the trial’s treatment arm will receive CMV-specific memory T cells while patients in the control arm will receive only conventional antiviral treatment. The Chief Investigator is Dr. Karl Peggs at the UCL Cancer Institute. The study is expected to be completed by the end of 2012 with results published in 2013.
The CMV~ACE/ASPECT study is being carried out at the following hospitals in the UK, subject to final local approvals: University College London Hospital, Queen Elizabeth Hospital, Birmingham, University Hospitals Bristol, King’s College Hospital, Manchester Royal Infirmary, The Christie Hospital Manchester, Nottingham City Hospital, Churchill Hospital Oxford, St James’s Institute of Oncology, Leeds, and The Royal Free Hospital.
The trial will complement an ongoing confirmatory (Phase III) study, CMV~IMPACT, which is investigating the use of adoptive cell therapy in bone marrow patients whose donors are siblings. The CMV~IMPACT Study is also sponsored by Cell Medica and funded through a Translation Award from The Wellcome Trust.
Gregg Sando, CEO of Cell Medica, commented:
“Cellular immunotherapy represents a new approach for the treatment of infectious disease. In view of the important patient benefits, we are working towards bringing cellular immunotherapy into routine clinical practice as quickly as possible. We share this commitment with Leukaemia & Lymphoma Research, NHSBT and University of Birmingham and all the participating hospitals and look forward to working together on this exciting clinical trial.”
References:
[1] Peggs KS, Thomson K, Samuel E, Dyer G, Armoogum J, Chakraverty R, Pang K, Mackinnon S, Lowdell MW. Directly selected cytomegalovirus-reactive donor T cells confer rapid and safe systemic reconstitution of virus-specific immunity following stem cell transplantation. Clin Infect Dis. 2011 Jan;52(1):49-57.
[2] Peggs KS, Verfuerth S, Pizzey A, Chow SL, Thomson K, Mackinnon S. Cytomegalovirus-specific T cell immunotherapy promotes restoration of durable functional antiviral immunity following allogeneic stem cell transplantation. Clin Infect Dis. 2009 Dec 15;49(12):1851-60.
[3] Kroger N, Zabelina T, Kruger W, Renges H, Stute N, Schrum J, et al. Patient cytomegalovirus seropositivity with or without reactivation is the most important prognostic factor for survival and treatment-related mortality in stem cell transplantation from unrelated donors using pre-transplant in vivo T-cell depletion with anti-thymocyte globulin. British Journal of Haematology. 2001 Jun;113(4):1060-71
[4] Ljungman P, Brand R, Einsele H, Frassoni F, Niederwieser D, Cordonnier C. Donor CMV serologic status and outcome of CMV-seropositive recipients after unrelated donor stem cell transplantation: an EBMT megafile analysis. Blood. 2003; 102:4255-60.
Notes to Editors:
Background to the trial = building on the success of earlier clinical studies
Early-stage clinical trials conducted independently by members of Cell Medica’s Scientific Advisory Team and including over 40 patients have demonstrated that adoptive cellular therapy can be used to prevent specific infections in patients following bone marrow transplants. The CMV~ACE/ASPECT study will build on these data to determine the level of immunological benefit in a statistically robust manner. The study will also seek to characterise the pharmaco-economics of treatment with Cytovir CMV.
About T cell immunotherapy for the treatment of CMV infection
T cell immunotherapy involves harnessing the power and precision of the human immune system to treat disease. Extensive academic research in the field of clinical immunology has shown that T cells have the ability to recognise and eliminate infections and have the potential to be used in a safe and efficacious manner as an antiviral treatment. Latent infection of cytomegalovirus (CMV) is estimated in over 50% of all humans and reactivation of the virus is one of the leading causes of potentially life threatening illness in immunosuppressed patients, often manifesting as interstitial pneumonitis. Adoptive T cell immunotherapy is based on the selection of CMV-specific memory T cells from the same donor providing the bone marrow (and hence closely matched with respect to tissue type) and infusion of these cells in the patient to prevent or treat CMV infections following a bone marrow transplant.
About Cell Medica
Cell Medica is a clinical cellular therapeutics company engaged in the development, manufacture and marketing of cellular immunotherapy treatments for infectious disease and cancer. The Company’s lead cell therapy, Cytovir CMV, targets the prevention of infections in immunosuppressed patients following allogeneic bone marrow transplant. Certain cancers are also targeted through the Company’s antigen-specific T cell approach. Cell Medica focuses on the commercialisation of cell therapies which have demonstrated clear evidence of safety and efficacy based on Phase I/II clinical trials.
Further more information, please contact:
Pevion Appoints Didier Hoch, Former President of Sanofi Pasteur MSD, as Chairman of the Board
ITTIGEN, Switzerland and BERN, Switzerland, February 10, 2011 /PRNewswire/ — Pevion Biotech Ltd. today announced the appointment of Didier Hoch as Chairman of its Board of Directors. Until recently, Dr Hoch was President of Sanofi-Pasteur MSD, where he played a pivotal role in launching innovative vaccines, such as Gardasil(R), in Europe.
Prior to his position as President of Sanofi-Pasteur MSD from 2000 until 2010, Didier Hoch was Vice President Africa & Middle East at Aventis Pharma International, and before that he was Deputy General Manager at Rhone-Poulenc Rorer France. From 2003 until 2009 Dr Hoch was President of the European Vaccine Manufacturers Association (EVM) and was Vice-President in 2002 and in 2010. Furthermore, he is President of the Biotechnology Committee of LEEM (the French pharma industry association) and President of the Life Science Health Committee of MEDEF (the French global industry association). He graduated in Medicine from the University of Lyon, France.
“I eagerly look forward to helping Pevion’s team build on the successes it has achieved to date,” Didier Hoch said following his election to become Chairman of Pevion. “Innovation is clearly what the vaccine industry currently needs. Through its proprietary and partnered programs, Pevion is a pioneer in the field of mucosal vaccines with its clinical stage, first-in-class vaccines against candidiasis and HIV, respectively. Furthermore, Pevion has novel vaccine approaches in clinical development to address diseases with clear unmet medical needs.”
“We welcome Didier Hoch to his new position as Chairman and look forward to working with him,” said Evert Kueppers, CEO of Pevion. “I am convinced that Didier’s in-depth expertise in developing and launching innovative vaccines, such as Gardasil(R), will give us important input and added value for the further in-house development of our clinical stage Candida vaccine, for which we could recently announce excellent Phase I interim data.”
Pevion also announced that its shareholders have appointed Daniel Richner, BZ Bank, as new member of the Board, replacing Dr Joseph Manko. Dr Richner has been working in the financial industry for 24 years, among others for the Lombard Odier Immunology Fund and HBM Bioventures. He joined BZ Fund Management in 2010, where he coordinates investments in the life sciences.
About Pevion Biotech Ltd.
Pevion Biotech Ltd. is an independent Swiss vaccine company that develops innovative vaccines for unmet medical needs based on its clinically and commercially validated virosome technology. Its proprietary clinical pipeline includes a first-in-class candidiasis vaccine. A clinical stage malaria vaccine candidate has been successfully outlicensed, and the Company’s technology has been licensed for use as an HIV vaccine currently in human trials. Pevion has in-house development capability and expertise, including a state-of-the-art and industrially scalable GMP manufacturing process. Located near Bern, Pevion was founded in 2002 as an industrial spin-off of Bachem AG (SWX: BANB) and Berna Biotech, now Crucell, (SWX: CRX), and raised a total of CHF 45 million to date from its founders and investors, BZ Bank, Core Capital Partners and BB Biotech Ventures.
About Virosomes
Virosomes are the only regulatory and market-approved vaccine technology to fulfill carrier and adjuvant functions in one. Essentially, virosomes represent reconstituted empty influenza virus envelopes, devoid of the genetic material of the source virus. As such, virosomes do not replicate and are therefore an ideal combination of carrier plus adjuvant for almost any given antigen, including peptide or protein derived antigens. The technology allows the surface display and delivery of difficult antigens and thereby provides access to new indications and markets. Two virosome-based vaccines (Epaxal(R) and Inflexal(R) V, marketed by Crucell Switzerland AG) are licensed in over 40 countries, and more than 70 million doses of these vaccines have been commercially distributed, thereby providing a solid safety and efficacy track record.
Pevion Biotech Ltd.
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Switzerland
EMD Serono Holds Grand Opening Ceremony for New State-of-the-Art Research Center in Billerica, MA
$65 million investment demonstrates EMD Serono’s commitment to the future of the life sciences industry in Massachusetts
Rockland, Massachusetts, February 10, 2011 /PRNewswire/ — EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced the opening of a state-of-the-art research center in Billerica, MA, establishing it as a “hub†within the Merck KGaA research organization. Representing a $65 million investment, the Billerica research facility supports the company’s commitment to developing and discovering innovative treatments in oncology, neurodegenerative diseases and infertility. Nearly 100 new jobs will be added in Massachusetts as a result of the building expansion.
“This research expansion represents EMD Serono’s clear purpose of scientific and medical innovation, and solidifies the company’s presence in Massachusetts as a leading, global organization in the life sciences industry,†said Fereydoun Firouz, President and CEO of EMD Serono, Inc. “We are focused on retaining and attracting the best scientists to develop therapies that provide value and breakthrough solutions to people living with serious medical conditions such as fertility disorders, cancer and neurodegenerative diseases.â€
The new site’s proximity to Boston reinforces EMD Serono’s existing networks and scientific collaborations, which include academic institutions, research organizations, hospitals and healthcare institutions. In addition, this research expansion is a strong indication of EMD Serono’s commitment to supporting economic growth in Massachusetts.
“The Massachusetts economy is an innovation economy, and EMD Serono’s new facility is one of the best examples of how that innovation translates into jobs and scientific advancement,†said Governor Deval Patrick. “This new facility will enhance Massachusetts’ position of global leadership in the life sciences, and the research that goes on here will lead to improvements in human health. This is just the sort of growth that we envisioned when we proposed the Life Sciences Initiative back in 2007 and I am confident there will be many more announcements like this to come.â€
“EMD Serono is developing treatments for some of the toughest medical challenges that we face, including neurodegenerative diseases, metabolic disorders and infertility. This new facility reflects the tremendous success that the company is having with its pipeline of innovative new drugs and therapies,†said Dr. Susan Windham-Bannister, President & CEO of the Massachusetts Life Sciences Center. “I congratulate EMD Serono on this important milestone and thank them for their commitment to growing in Massachusetts.â€
The new site will accommodate approximately 200 scientists with expertise in cancer biology, cancer immunotherapy, oncogene signaling, medicinal chemistry, molecular modeling, protein engineering, therapeutic antibodies and manufacturing cell lines across the core therapeutic areas of neurodegenerative diseases, cancer and infertility.
“The research institute in Billerica will bring together EMD Serono scientists, researchers and stakeholders in our research network which allows for greater synergy, collaboration and development of innovative science,†said Dr. Bernhard Kirschbaum, Executive Vice President, Research and Development, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “In addition, the establishment of EMD Serono’s research facility center of excellence in Massachusetts provides an opportunity to tap into world-renowned academic and research institutions that are located in close proximity to our new facility in order to further collaborate with a common objective to drive science forward.â€
The Billerica facility is one of four Research & Development hubs within Merck Serono; other R&D centers are located in Germany, Switzerland and China. These state-of-the-art facilities foster enhanced collaboration and synergies to discover and develop innovative therapies. The research facility located in Billerica is focused on the therapeutic areas of infertility, oncology and neurodegenerative diseases. The R&D site in Germany is focused on the therapeutic areas of rheumatology and oncology, and the location in Switzerland is focused on neurodegenerative diseases and rheumatology.
The 140,000 square foot (sf) Billerica facility accommodates over 115,000 sf of lab and office space, consisting of: 25,000 sf of chemistry and screening labs; 25,000 sf biology and cell culture labs; 22,000 sf of general lab support space; 20,000 sf of office and conference rooms and 23,000 sf of mechanical space.
EMD Serono is committed to environmental responsibility and currently is working toward Leadership in Energy and Environmental Design (LEED) Gold certification at this facility within the following categories: indoor environment quality, sustainable sites, water efficiency, energy and atmosphere, and materials and resources.
EMD Serono worked with a number of Massachusetts businesses on this project. The architect on the research facility was Ellenzweig. The construction manager was Jones Lang LaSalle, a global real estate services and construction management corporation. The Mechanical Engineers of the facility were BR+A, LLC Consulting Engineers, the Civil Engineers were BSC Group and the Geotechnical Engineers were GEI Consultants.
About EMD Serono, Inc.
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people’s lives. The company has strong market positions in neurodegenerative diseases, with Rebif® (interferon beta-1a), as well as in endocrinology, with Saizen® (somatropin (rDNA origin) for injection), Serostim® (somatropin (rDNA origin) for injection) and EGRIFTATM (tesamorelin for injection). EMD Serono is a leader in reproductive health, with Gonal-f® (follitropin alfa for injection), Luveris® (lutropin alfa for injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection). In addition, EMD Serono is growing its expertise and presence in the area of oncology, with more than 10 projects currently in development. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono’s US footprint continues to grow, with more than 1100 employees around the country and fully integrated commercial, clinical and research operations in the company’s home state of Massachusetts.
For more information, please visit www.emdserono.com
Valeant Pharmaceuticals Announces Acquisition of Cholestagel® in Canada
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MISSISSAUGA, Ontario, Feb. 10, 2011 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has acquired the Canadian rights to Cholestagel® (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, from Genzyme Corporation (“Genzyme”). Genzyme will receive from BLS a $2 million upfront payment, to be followed by subsequent additional milestone payments totaling up to $7 million.
“Cholestagel® is a strong addition to our Canadian franchise,” said J. Michael Pearson, chief executive officer. “While this compound is currently pending marketing approval from Health Canada, the use of Cholestagel® has been shown to be effective as an adjunctive option in the treatment of high levels of cholesterol in the blood in the countries where it is currently marketed. This product will be promoted by our existing sales force in Canada and will be a complementary fit with our existing Tiazac® XC promotions.”
About Cholestagel® (colesevelam)
Colesevelam is a bile acid sequestrant administered orally. It is developed by Genzyme and marketed in the U.S. by Daiichi Sankyo under the brand name WelChol and elsewhere by Genzyme under the tradename Cholestagel®. Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia as monotherapy and combination therapy with a statin.
Unlike most other cholesterol-lowering agents, colesevelam is non-systemic, and therefore is not absorbed into the bloodstream. Colesevelam binds bile acids in the intestine, impeding their reabsorption. This process – called bile acid sequestration – results in an increased clearance of LDL-C from the blood. Colesevelam is also well-tolerated, with minimal gastrointestinal side effects similar to those seen with placebo, and has limited drug interactions.
Important Safety Information
In clinical trials with Cholestagel® (colesevelam), the most common (incidence > 2% and greater than placebo) adverse reactions with Cholestagel® included constipation, dyspepsia, and nausea. In the diabetes trials, the overall incidence of hypoglycemia was 3.0% in Cholestagel® – treated patients and 2.3% in placebo-treated patients.
Post-marketing ADR (adverse drug reactions) reports include bowel obstruction, dysphagia, esophageal obstruction, fecal impaction, hypertriglyceridemia, pancreatitis and increased transaminases. Additionally some interaction reports were received describing changes in phenytoin levels, reduced International Normalized Ratio (INR), and elevated thyroid-stimulating hormone (TSH). However, because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cholestagel® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Cholestagel® is contraindicated in patients with bowel or biliary obstruction. Cholestagel® is contraindicated in patients with serum triglyceride (TG) > 500 mg/dL and in patients with a history of hypertiglyceridemia-induced pancreatitis.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics. More information about Valeant can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information as defined under applicable Canadian securities legislation (collectively, “forward-looking statements”). These forward-looking statements relate to, among other things, the promotion of Cholestagel® in Canada and its fit with our existing products. Forward-looking statements can generally be identified by the use of words such as “believe”, “anticipate”, “expect”, “estimate”, “intend”, “continue”, “plan”, “project”, “will”, “may”, “should”, “could”, “would”, “target”, “potential” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things, the risk factors as detailed in Valeant’s most recent annual and quarterly reports filed with the Securities and Exchange Commission (“SEC”) and the Canadian Securities Administrators (“CSA”). Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
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Contact:
Laurie W. Little
Valeant Pharmaceuticals
949-461-6002
SOURCE Valeant Pharmaceuticals International, Inc.
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Caliper Life Sciences IVIS® Optical Imaging System Adoption Surpasses 1000 Units: Validated Drug Research, Discovery and Development Tool Enables Advances in Personalized Medicine
– Over 60 IVIS Systems sold in the Fourth Quarter of 2010 –
– 1000th IVIS System Installed at Northwestern University for Non-Invasive Cancer Research Imaging –
HOPKINTON, Mass., Feb. 10, 2011 /PRNewswire/ — Caliper Life Sciences, Inc. (Nasdaq: CALP), a leading provider of tools and services for drug discovery, life sciences research and molecular diagnostics, today announced it has installed the 1000th IVIS preclinical imaging system, a milestone event in the continued rapid adoption of Caliper’s proprietary in vivo imaging solutions. The Center for Advanced Molecular Imaging at Northwestern University purchased Caliper’s IVIS Spectrum to enable nano-particle technology research for the targeting of cancer tumors and non-invasive monitoring of tumor progression and therapeutic response in living subjects.
Caliper’s IVIS imaging technology is the leading tool in the rapidly growing field of preclinical non-invasive optical molecular imaging. The technology provides researchers with novel capabilities to explore the molecular basis of disease and response to drug therapies in individual animal models over time-course studies without the need for invasive procedures maintaining the relevancy of biological model at hand. The use of IVIS technology has assisted in the discovery and development of at least 13 compounds that have moved into clinical testing, 5 of which are FDA approved treatments, and in the generation of more than 2,650 peer-reviewed publications, attesting to the value of IVIS technology in a broad range of therapeutic areas, including biomarker discovery, cancer research, stem cells, infectious disease, inflammation, metabolic disease, neurology, cardiovascular disease and toxicology.
“The Center for Advanced Molecular Imaging at Northwestern facilitates research fueling a greater understanding of disease and treatment options, so it is critical that the Center offer the University research community reliable technology solutions that are innovative and fundamentally enabling. The IVIS Spectrum provides an unparalleled combination of bioluminescence and fluorescence optical capabilities in a single, state-of-the-art instrument,” said Dr. Thomas Meade, Director of the Center for Advanced Molecular Imaging (CAMI) in the Chemistry of Life Processes Institute at Northwestern University, Evanston Campus.
“Caliper’s preclinical imaging solutions have gained rapid acceptance throughout the pharmaceutical and academic research communities. Researchers around the world rely on IVIS to provide meaningful, impactful molecular insights that simply could not be achieved through conventional means,” said Kevin Hrusovsky, President and Chief Executive Officer of Caliper. “Placing the 1000th IVIS system at a prestigious institution such as Northwestern University is a testament to Caliper’s partnership within the research community and our ability to commercialize leading-edge technology in strong collaboration with them. As evidenced by our recent acquisition of CRi, which adds multiplexed tissue analysis to our portfolio, we are continuing to invest in building out our vision of being the premier platform partner to enable personalized medicine.”
For additional information on Caliper’s portfolio of imaging systems, please visit http://www.caliperls.com/IVIS
About Caliper Life Sciences
Caliper Life Sciences is a premier provider of cutting-edge technologies enabling researchers in the life sciences industry to develop life-saving and enhancing medicines and diagnostic tests more quickly and efficiently. Caliper is aggressively innovating new technology to bridge the gap between in vitro assays and in vivo results that translate into potential cures for a range of diseases. Caliper’s portfolio of offerings includes state-of-the-art microfluidics, lab automation & liquid handling, optical imaging technologies, and discovery & development outsourcing solutions. For more information please visit www.caliperLS.com.
Caliper and IVIS are registered trademarks of Caliper Life Sciences, Inc.
SOURCE Caliper Life Sciences, Inc.
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Americord Becomes Only Family Cord Blood Bank Headquartered in New York City to Hold State Cord Blood License
License Paves the Way for Americord to Offer Cord Blood Banking Across the Country
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NEW YORK, Feb. 9, 2011 /PRNewswire/ — Americord Registry, a pioneer in cord blood and placenta stem cell preservation, is proud to announce that it has obtained a provisional human tissue cord blood banking license from the New York State Department of Health, becoming the first private umbilical cord blood bank headquartered in New York City with the authority to collect umbilical cord blood in the state of New York.
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“The New York State licensing requirements are very rigorous and the license is one of the most difficult accreditations to earn. Only the highest quality cord blood banks, such as The New York Blood Center, which operates the oldest and largest public cord blood bank, are able to meet these very strict requirements,” said Martin Smithmyer, President and CEO of Americord.
Most states only require that cord blood banking organizations register their in-state laboratories. New York, on the other hand, licenses the organizations themselves, and requires them to follow meticulous protocols before their labs can collect cord blood. With this license, Americord is currently is able to accept cord blood from nearly all 50 states, as well as many international locations.
For more information about Americord Registry, or to speak with Mr. Smithmyer, please contact Dana Taormina at 973-732-3521 or dana@jcprinc.com.
About Americord Registry
Americord Registry is a pioneer in cord blood and placenta stem cell preservation. Americord collects, processes, and stores newborn stem cells from umbilical cord blood for future medical or therapeutic use, including the treatment of more than 75 blood diseases such as sickle cell anemia and leukemia.
Founded in 2008, Americord is registered with the Food and Drug Administration and is licensed in New York and New Jersey. The company’s laboratory is accredited by the AABB, and complies with federal CLIA laboratory standards. Americord is based in New York. To learn more, visit www.americordregistry.com
Rcadia COR Analyzer System Receives Expanded FDA Clearance to Rule Out Coronary Artery Disease in Coronary Branch Vessels
NEWTON, Mass., Feb. 9, 2011 /PRNewswire/ — Rcadia Medical Imaging announced today that it has received FDA 510(k) marketing clearance for an enhanced version of its COR Analyzer® System to assess coronary branch vessels in addition to main coronary arteries in patients with suspected coronary artery disease (CAD). The clearance is the third for the COR Analyzer System, a unique clinical decision support tool that automatically detects significant (50 percent and over) stenotic lesions in coronary arteries from Coronary CT Angiography (cCTA) studies.
“The enhanced version expands the benefits of the COR Analyzer System as a powerful complement to cCTA in evaluating suspected CAD patients,” said Shai Levanon, President and CEO of Rcadia. “By providing rapid detection of stenotic lesions our system enables expanded use of cCTA to enhance patient care and reduce unnecessary costs.”
The FDA clearance follows the recent publication of the first clinical study evaluating the COR Analyzer’s enhanced version. The study, published (online) in Academic Radiology in January 2011 by researchers at Thomas Jefferson University, demonstrated that the “COR Analyzer provides a high negative predictive value for the absence of coronary disease in branch vessels as well as the major coronary arteries.”
The retrospective study, conducted by Ethan Halpern, MD, and David Halpern, compared 207 cases evaluated by the COR Analyzer System with expert interpretation. The final clinical interpretation identified 48 patients with significant (over 50 percent) stenosis. The COR Analyzer System demonstrated a sensitivity of 92 percent and a negative predictive value of 97 percent. In the study, the system’s specificity was 70 percent and the positive predictive value was 48 percent.
The investigators noted that the “high negative predictive value will be most useful in a population with a low prevalence of coronary disease – such as the emergency room chest pain population – where the COR Analyzer might be used to facilitate the rapid discharge of a majority of patients who have normal coronary CTA studies during all hours of the day or night.”
About Rcadia Medical Imaging
Rcadia Medical Imaging Ltd. develops and markets proprietary computerized systems that automatically detect clinical abnormalities in digital medical images, particularly for patient triage in emergency, life threatening conditions. The company’s first FDA-cleared product, the COR Analyzer® System, provides fully automated, real-time analysis of Coronary CT angiography to enable the practical application of cCTA in detecting significant coronary artery disease. The COR Analyzer improves the utility of Coronary CTA studies in the emergency department to triage chest pain patients and optimizes work flow in cardiology and radiology departments. Learn more at www.rcadia.com.
SOURCE Rcadia Medical Imaging
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NOVAVAX to Present H1N1 VLP Influenza Vaccine Clinical Data at 7th World Health Organization (WHO) Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials
ROCKVILLE, Md., Feb. 9, 2011 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX) a clinical-stage vaccine company, announced today that Dr. Gregory Glenn, Chief Medical Officer of Novavax, will be presenting safety and immunogenicity data from its pivotal 2009 A/H1N1 virus-like particle (VLP) pandemic influenza vaccine clinical trial in Mexico, at the invitation-only 7th WHO Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials. The meeting is being held February 17-18, 2011 at the WHO headquarters in Geneva, Switzerland where Dr. Glenn will be part of a session entitled: “Pandemic and Potentially Pandemic Vaccines Developed Using New Technologies.” Dr. Glenn’s presentation is entitled: “Rapid Response during the 2009 (H1N1) Pandemic in Mexico with an Influenza VLP Vaccine.” The presentation will be available at www.novavax.com under the Investors/Events tab after the event.
About Novavax
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs it’s cutting edge technology to create next generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary VLP technology and unique disposable system enables rapid vaccine development and production where and when it’s needed, worldwide. For more information about Novavax, please visit www.novavax.com.
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PARI Respiratory Launches New Website
MIDLOTHIAN, Va., Feb. 9, 2011 /PRNewswire/ — Today, PARI Respiratory Equipment launched an updated company website at www.pari.com. In addition to providing visitors with a beautiful new interface, the website includes easy access to:
* Continuing Education classes
* Product instructional videos
* Frequently asked questions and answers for patients
* Product instructions for use
* Information on how to access and differentiate between various types of nebulizers, compressors, holding chambers, masks, and sinus nebulizers
“In our continuous commitment to patients, caregivers, and physicians, we decided to modify pari.com to provide enhanced respiratory care and product information,” said Geoff A. Hunziker, president of PARI Respiratory Equipment. “It is easier than ever to determine which gold standard PARI nebulizer fits a patient’s needs, how to use that nebulizer and the compressor that powers it, and view additional options for care.”
“We are excited to include a new technology in the video section that is really unique. With flowplayer, we provide easy access to videos and animated shorts showing how PARI nebulizers, sinus nebulizers, and our exclusive Timestrip indictor work. This is a fun way for kids, parents, and adults to learn the technical ins and outs of nebulizers, and it helps clinicians explain why compliance makes a difference in the effectiveness of therapies,” said Ashley Weigand, marketing manager for PARI Respiratory Equipment.
Check out all the fun features at www.pari.com.
About PARI Respiratory Equipment, Inc.
PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. PARI’s worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them.
Maker of the world’s leading breath-enhanced reusable nebulizer, the PARI LC PLUS, and the new PARI LC Sprint nebulizer line, PARI also manufactures the award winning PARI TREK S compact compressor, Bubbles the Fish II aerosol mask, and durable PARI PRONEB Ultra II. PARI’s Vortex anti-static valved holding chamber improves the aerosol deposition of metered dose inhalers (MDIs). PARI’s North American headquarters is in Midlothian, VA with worldwide headquarters in Starnberg, Germany.
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PRA Expands Operations in Europe and Middle East
Continued Growth Prompts New Office Openings
RALEIGH, N.C., Feb. 9, 2011 /PRNewswire/ — PRA International, a leading Clinical Research Organization, announces the opening of new offices in Israel and the Ukraine to accommodate the firm’s continued global expansion and enhance our offerings for clients. This growth demonstrates PRA’s commitment to meet the increased demand for services in the Middle East and Eastern Europe.
PRA’s Israel office is conveniently located in Tel Aviv and will enhance local staff members’ availability to provide services in this area to our clients. PRA established an initial presence in Israel in 2007 through partnerships with local contractors. As demand increased, the company began hiring employees to advance operational capabilities there. Over the past several years, PRA has built a staff of 17 full-time employees, including clinical research associates, clinical team managers and various other positions needed to conduct full-service Phase II through IV clinical trials.
In the Ukraine, PRA has established an office in Kiev. Located in the business district of Podil, the facility is ideally situated to provide quality clinical research services in the country. PRA currently employs 15 staff members in the Ukraine, including 10 clinical research associates. With a population of nearly 50 million, the Ukraine has emerged as an attractive location for global studies.
“We are pleased to be able to provide an increased level of staffing through new offices in these two countries,” said Dr. Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia-Pacific and Africa. “These facilities bolster our offerings by providing centralized support for local teams to serve our clients in these regions.”
In addition to enhancing PRA’s abilities to manage a broad range of clinical trials across varying therapeutic indications, the new facilities further strengthen the company’s global presence.
About PRA
PRA conducts clinical trials across all therapeutic areas in more than 80 countries and provides services in all phases of clinical development through its 39 global offices.
PRA’s therapeutic expertise, global reach and project experience combined with its extensive local knowledge and differentiating philosophy—THE PERSONAL ELEMENT— enable its project teams to deliver consistent and on-time performance. This unique PRA philosophy recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to be innovative and to use their personal commitment to accelerate the development life cycle.
To learn more about PRA International, please visit www.PRAinternational.com, email Endpoints@PRAintl.com or call our Global Headquarters at +1 (919) 786-8200.
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FDA Says Drug Firms Didn’t Finish Follow-Ups
Federal officials Tuesday questioned companies that make six cancer drugs about their failure to complete follow-up studies they promised to conduct in exchange for accelerated approval.
The issue is one of the most sensitive for the FDA, which says it wants to speed potentially lifesaving drugs onto the market while also making sure there’s evidence the drugs work. The agency faces pressure from patients and doctors who say it’s better to provide fast access than to wait for full data.
In a compromise dating from the early 1990s, the FDA has granted accelerated approval several dozen times to cancer drugs based on preliminary evidence. Companies then promise to confirm the evidence in follow-up studies.
The FDA can fine companies millions of dollars or revoke approval if the evidence isn’t forthcoming. At Tuesday’s meeting, FDA officials stopped short of making those threats against the companies making the six drugs—which include Amgen Inc., GlaxoSmithKline PLC and Eli Lilly & Co.—but spoke generally about the value of timely confirmation.
“These confirmatory trials are as important—if not more important—than the initial trials leading to the accelerated approval,” said Richard Pazdur, the head of the FDA’s cancer division. He said some companies have taken more than six years to complete the trials.
The meeting took place in the shadow of a recent announcement by the FDA that it intends to revoke the accelerated approval of the blockbuster drug Avastin for use in treating breast cancer, a move that has jolted the industry and provoked outrage among many women across the country who have asked Congress to intervene.
The FDA said follow-up studies by Avastin maker Genentech, a unit of Roche Holding AG, failed to show that the drug significantly delays the spread of tumors in breast-cancer patients. Genentech is appealing the decision and says the FDA misinterpreted the studies.
Former FDA Deputy Commissioner Scott Gottlieb, who now invests in and consults for drug companies, was critical of some of the FDA mandates and said the result might be to delay badly needed drugs.
“The oncology division has long felt that the accelerated approval provisions were too permissive and have worked over a period of about eight years to unwind the spirit of the statute,” he said.
Others said the bar for accelerated approval was too low. “We are willing to accept drugs with the most minimal evidence,” said Silvana Martino, who runs the breast-cancer program at the Angeles Clinic and Research Institute in Santa Monica, Calif.
It was the first such meeting at the FDA since 2005. Dr. Pazdur said the agency wants to hold the gathering every year because there’s “nothing like the light of day” to show where companies need to perform. He also said that if companies aren’t confident they can complete follow-up studies on time, they may want to avoid seeking accelerated approval in the first place.
Several companies said Tuesday that they had difficulties finishing some of the mandated studies because they could not find enough patients to generate reliable results.
One drug, Glaxo’s Bexxar, was initially approved in 2003 for a specific lymphoma. It got accelerated approval in 2004 for use in patients with a rarer form of the cancer who, in most cases, had exhausted other treatment options, said a Glaxo spokesman. With smaller patient pools, it can be hard to recruit the numbers needed to conduct the trials, he said.
Lilly said it has met with the FDA to discuss data for the drug Erbitux in some types of colorectal cancer. The company said it continues to “work diligently to fulfill the remaining postmarketing commitment for Erbitux, which we expect to do later this year.” Amgen said it met its commitments with due diligence.
The FDA has agreed that some trials promised by companies can’t be carried out because the treatment protocols they were designed to test became outdated.
European regulators have a program similar to accelerated approval except that the conditional approval is granted only for a year, after which it can be renewed. That means companies have to show consistently that they are making progress toward meeting their commitment.
In five cases, studies failed to confirm benefit and drugs were withdrawn or faced new restrictions, according to the FDA. That happened in 2005 to AstraZeneca PLC’s lung-cancer drug Iressa, which failed to show survival benefit in a large trial and was pulled except for patients already on the drug.
“We expect a small percentage of products to fail to confirm a benefit. This is the trade-off for earlier availability of promising agents for severe and life-threatening diseases,” said Dr. Pazdur.
A.P. Pharma Provides Update on APF530 Program and NASDAQ Listing
REDWOOD CITY, Calif.–(BUSINESS WIRE)–A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical company, today provided an update on its progress toward responding to the Complete Response Letter for APF530 that the Company received from the U.S. Food and Drug Administration (FDA) in March 2010. The Company also announced that it has met with the NASDAQ Listing and Qualifications Panel (Panel) and is now awaiting its decision regarding A.P. Pharma’s eligibility for continued listing.
“A.P. Pharma’s management team has focused its efforts on addressing the issues included in the APF530 Complete Response Letter and we have arranged Type B meetings with the FDA for later this quarterâ€
“A.P. Pharma’s management team has focused its efforts on addressing the issues included in the APF530 Complete Response Letter and we have arranged Type B meetings with the FDA for later this quarter,†said John Whelan, A.P. Pharma’s acting chief executive officer. “We intend to discuss our plans for addressing the issues raised by the FDA, and to obtain clarification on what should be included in a resubmission of the program’s New Drug Application. Following the meetings with the FDA, we expect to be in a position to determine the resources and timeline needed for resubmitting the New Drug Application for APF530.â€
Although specific meeting times have been scheduled with the FDA, there can be no assurance that these dates will not be changed or the meetings cancelled.
The Company recently met with the Panel to discuss the Company’s plans for regaining compliance with Listing Rule 5550(a)(2). The Company received a second letter from NASDAQ on November 17, 2010 noting that the minimum bid price of its common stock price continued to close below $1.00 per share, making it subject to delisting. A.P. Pharma requested a hearing and met with the Panel to present the Company’s plan for regaining compliance. The Panel may decide to allow the Company to remain listed in order to regain compliance per the plan presented, or decide to delist the Company. There can be no assurance that the Panel will grant the Company’s request for continued listing on The NASDAQ Stock Market. In the event that the Panel determines to delist the Company’s securities from NASDAQ, the Company’s common stock may be eligible for trading on the OTC Bulletin Board, which is operated by FINRA, or the OTCQB, which is operated by OTC Markets.
As previously announced, the Company is actively seeking debt or equity financing to fund its operations. The Company is taking additional actions to conserve its capital such that it anticipates having sufficient funds to operate into the second quarter of 2011. Multiple factors, including market conditions, may prevent the Company from obtaining adequate financing to support its operations, or obtaining financing on terms favorable to A.P. Pharma or its stockholders.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomerâ„¢ polymer-based drug delivery technology. The Company’s primary focus is on its lead product, APF530, for the prevention of chemotherapy-induced nausea and vomiting. A.P. Pharma received a Complete Response Letter on the APF530 New Drug Application in March 2010 and is in the process of preparing a resubmission responsive to the deficiencies listed in the Complete Response Letter. The Company has additional clinical and preclinical stage programs in the area of pain management, all of which utilize its bioerodible injectable and implantable delivery systems. For further information, please visit the Company’s web site at www.appharma.com.
FDA approves 1st pacemaker designed to work safely during some MRI exams
The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.
Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.
About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI’s magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker’s use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.
“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI.”
The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.
Revo is manufactured by Medtronic Inc. of Mounds View, Minn.
Shire Strengthens Specialty Pharmaceuticals Team With Senior R&D Appointments
NYON, Switzerland and PHILADELPHIA, Feb. 8, 2011 /PRNewswire/ — Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the appointment of two senior Research & Development executives to its Specialty Pharmaceuticals business. Lawson Macartney, DVM, PhD, FRCPath, has been appointed Senior Vice President of the Emerging Business Unit and Mario Saltarelli, MD, PhD, has been named Senior Vice President of Clinical Development and Medical Affairs.
“The experience and expertise that Drs. Macartney and Saltarelli bring to the Shire team will help us advance our pipeline, more effectively manage the lifecycle of our medicines, and provide growth opportunities – all in the spirit of helping patients with life-altering conditions to lead better lives,” said Jeffrey M. Jonas, MD, Senior Vice President of Research & Development for Shire’s Specialty Pharmaceuticals business and to whom Drs. Macartney and Saltarelli will report.
As leader of Shire’s Emerging Business Unit, Dr. Macartney is responsible for the early pipeline and development efforts of Shire’s Specialty Pharmaceuticals business, which is centered on attention deficit hyperactivity disorder (ADHD) and gastrointestinal diseases. Based initially in Shire’s Wayne, PA office and transitioning to Shire’s Nyon, Switzerland office, Dr. Macartney will direct the Research & Development evaluation of new product opportunities and explore new therapeutic areas for Shire’s Specialty Pharmaceuticals business.
Dr. Macartney brings to Shire a wealth of global drug development and commercialization experience. He spent nearly 20 years working with GlaxoSmithKline (GSK) where he most recently served as Senior Vice President of Global Product Strategy and Project/Portfolio Management. Throughout his time at GSK, Dr. Macartney held leadership roles in the Cardiopulmonary Therapeutic Area, from Project Leader to Global Head for Cardiovascular, Metabolic and Urology. Prior to his experience at GSK, he worked at AstraMerck and Astra Pharmaceuticals in leadership roles in operations, marketing and customer service. Dr. Macartney is trained as a veterinarian and received his Ph.D. from Glasgow University Veterinary School in Scotland where he was a Royal Society Research Fellow.
In his role as Senior Vice President of Clinical Development & Medical Affairs for Shire’s Specialty Pharmaceuticals business, Dr. Saltarelli will be based in Shire’s Wayne, PA offices and provide overall scientific and professional leadership as well as clinical and medical strategies for Shire’s global drug development programs.
Dr. Saltarelli’s diverse background spans nearly two decades across medical science, clinical drug development, and the scientific and regulatory aspects of clinical program design. He joins Shire from Abbott Laboratories where he served as the Divisional Vice President directly accountable for all aspects of clinical development, medical affairs, and development strategy for Global Neuroscience and Anesthesia products. Prior to that, Dr. Saltarelli spent seven years at Pfizer Global Research and Development in Connecticut, ultimately as Executive Director of the CNS Early Clinical Development Group, and he served for four years as an Assistant Professor of Neurology at Emory University School of Medicine. Dr. Saltarelli earned a BS in Psychology from the University of Illinois at Urbana-Champaign, an MD in Medicine and a PhD in Neuropharmacology from The Johns Hopkins University. Dr. Saltarelli was an intern at the University of Maryland Medical Center and spent his Neurology residency at Johns Hopkins Hospital.
Notes to editors
SHIRE PLC
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
SOURCE Shire plc
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Pervasis Receives FDA Fast Track Status for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Novel Cell-Based Therapy Addresses Serious Unmet Medical Need, Aims to Reduce Need for Repeat Surgical Procedures and Improve Patient Outcomes
CAMBRIDGE, Mass., Feb. 8, 2011 /PRNewswire/ — Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).
Vascugel, a novel endothelial cell-based therapy and Pervasis’ lead development program, aims to regulate the body’s healing response following surgical interventions to create vascular access points which are necessary for ESRD patients undergoing hemodialysis, reducing the need for repeat surgical interventions and improving overall patient outcomes.
FDA established Fast Track to facilitate the development and accelerate the pre-market review of treatments for serious and life-threatening conditions, so that these products can reach approval more rapidly. To receive Fast Track designation, a product must address a serious unmet medical condition, and be supported by strong results from pre-clinical or clinical testing demonstrating the product potential.
Vascugel has demonstrated clinical proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access for hemodialysis. In these trials, Vascugel exhibited an excellent safety profile and encouraging efficacy trends were observed, including improved duration of patency (or unimpeded blood flow) and a delay in time to first intervention as compared to placebo.
“The fact that these very sick patients must endure serious complications and repeat surgical procedures so that they can continue undergoing hemodialysis represents a significant unmet medical need—one that Vascugel is uniquely able to address,” stated Frederic Chereau, president and CEO of Pervasis. “Fast Track designation from the FDA further validates Vascugel’s potential as a safe and effective therapy for patients with end stage renal disease, and will help accelerate the pace by which we can develop and deliver this potentially transformational cell-based therapy to improve patient outcomes.”
In May 2009, Pervasis received Orphan Drug Designation from the FDA for Vascugel in patients with ESRD. Last year, Pervasis announced that it had reached an agreement with the FDA for a Phase 3 clinical trial of Vascugel under the Agency’s Special Protocol Assessment (SPA) procedure. Through the SPA procedure, FDA formalized its agreement that the design of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval. Pervasis is also awaiting official Orphan Drug Designation from the European Medicines Agency (EMA) after receiving a positive opinion on its application from The Committee for Orphan Medicinal Products (COMP) late last year.
Failure of Hemodialysis Access Points Leads to Poor Outcomes
ESRD is an advanced and irreversible condition treated mainly by hemodialysis or kidney transplantation. It is estimated more than 350,000 Americans with ESRD receive hemodialysis, a blood purification therapy designed to replace critical kidney functions – such as filtering waste.
During hemodialysis, blood is removed from the body, filtered through a dialyzer, or artificial kidney, and then returned to the body. Patients must undergo a surgical intervention to create a vascular access point that enables blood to flow from the body to the dialyzer and back to the body. AV fistulae (created by directly joining an artery and vein) and AV grafts (created using a synthetic tube to join an artery and vein) are the two primary types of hemodialysis access points.
Due to an inflammatory cascade triggered by surgical intervention, these vascular access points often have difficulty healing, and quickly become unusable or clot rapidly, prompting the need for additional, recurring surgeries to create new access points and also leading to multiple complications. Up to 60 percent of all arteriovenous (AV) grafts require re-intervention after one year.(1,2) AV access failure is the most common reason for hospitalization among hemodialysis patients and can lead to anemia, infection, weight loss, jaundice, prolonged bleeding, and other serious complications.(3)
Vascugel – Combating Inflammation and Promoting Healing
Pervasis’ novel approach to cell therapy uses adult-differentiated allogeneic endothelial cells (donor endothelial cells with a highly targeted biologic function) embedded in a patented polymer matrix to enhance the body’s natural healing response. The endothelium is the thin layer of cells that lines the interior surface of blood vessels in the body. Endothelial cells are critical to tissue repair and health, and have a well-understood role in regulating many of the body’s healing processes, including those associated with vascular repair.
Vascugel, which utilizes Pervasis’ patented endothelial cell-based platform, is placed on the outside of the blood vessel at the AV access site during the surgical intervention to create the AV access point. The endothelial formulations in Vascugel secrete several factors that combat inflammation and promote proper vascular healing, reducing thrombosis (or clotting) and the formation of intimal hyperplasia, or a thickening of the blood vessel wall in response to injury. After approximately four to eight weeks, Vascugel is safely resorbed by the body.
The company’s other areas of clinical investigation include improving outcomes in patients with peripheral artery disease (PAD) following surgical procedures such as percutaneous transluminal angioplasties (PTAs) with stenting, the failures of which result in serious complications and a significant increase in medical costs. Last month, Pervasis announced it has also embarked on an oncology development program using its proprietary endothelial cell-based platform to prevent solid tumor growth, cancer recurrence and metastatic disease.
About Pervasis
Pervasis Therapeutics, Inc. is a clinical stage company developing a broad portfolio of biologically active therapeutics. Building on its deep understanding of the specialized role that the endothelium plays in regulating natural healing and repair processes associated with disease, Pervasis is advancing groundbreaking new therapies to dramatically improve the outcomes of common vascular interventions, such as arteriovenous access, angioplasties, stents, and peripheral and coronary bypass grafts – the failure of which result in serious complications and a significant increase in medical costs. The company’s most advanced program, Vascugel®, has demonstrated proof of concept and safety in two Phase 2 trials in patients undergoing vascular access for hemodialysis. In addition, Pervasis is pursuing a cell-based oncology program focused on targeting and regulating cell stroma in order to prevent key processes that play a role in advancing solid tumor growth and survival. Pervasis is also applying its platform technology to develop products in other key therapeutic areas including inflammatory disease and orthopedic injury.
Pervasis is a privately held company with funding from Flagship Ventures, Polaris Venture Partners, Highland Capital Partners and the Richter Family Fund. For more information, please visit www.pervasistx.com.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such statements are only predictions and the company’s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the timing of clinical trials, the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in clinical trials and the risk that the company will not obtain approval to market its products.
(1) Dixon et al. DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009; 360: 2191-2201.
(2) Hayashi et al. Vascular access for hemodialysis. Nat Clin Pract Nephrol 2006; 2: 504-513
(3) Castner D. Recommendations for tracking arteriovenous access complications using a charting-by-exception model. Anna Journal, 1998; 25(4): 393-396.
Company Contact:
Margaret O’Toole
Pervasis Therapeutics, Inc.
617-871-1201
motoole@pervasistx.com
Media Contact:
Liz Falcone
Feinstein Kean Healthcare
617-256-6622
liz.falcone@fkhealth.com
SOURCE Pervasis Therapeutics, Inc.
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Medical Device, Renewable Energy, and Web Services Ventures Named Among Semi-Finalists in Zell Lurie Institute’s Annual Michigan Business Challenge
Multi-phase Business Development ‘Boot Camp’ Supports Action-based Approach to Entrepreneurial Education
ANN ARBOR, Mich., Feb. 8, 2011 /PRNewswire-USNewswire/ — The Samuel Zell & Robert H. Lurie Institute for Entrepreneurial Studies at the University of Michigan Ross School of Business today announced that eight teams have advanced to the semi-finals of this year’s Michigan Business Challenge. The multi-round business plan competition is a cornerstone of the Institute’s action-based educational programming, which enables students to put their entrepreneurial passions into practice while studying and provides them the resources necessary to transform promising business ideas into successful ventures.
Now in its 28th year, The Michigan Business Challenge has evolved from a one-day competition to encourage entrepreneurship and business development among students into a four-month event that exposes students across the University to the rigorous business development and planning process required to commercialize a great idea. Nearly half of the competing teams include students from Engineering, Medicine, Law, and other areas of study, and all teams are provided with training and invaluable feedback at each phase from judges, which include seasoned business leaders and professional leaders.
“In the past decade alone, the Michigan Business Challenge has engaged over 500 teams, many of which have gone on to grow into successful ventures here in Michigan and far beyond,” said Tom Kinnear, Executive Director of the Samuel Zell & Robert H. Lurie Institute for Entrepreneurial Studies. “Many students come here eager to bring their own business ideas to fruition, leveraging coursework and programs such as this one to fine-tune plans, develop go-to-market strategies and establish important relationships. It is the opportunities created by this action-based education that sets the Institute apart from other entrepreneurial programs out there.”
The 2011 semi-finalist teams represent sectors including medicine, life sciences, high technology and web services. They are:
* Brio Device – a medical device company whose flagship product, SmartAirway, is designed to improve the success of emergency intubations.
* IRIZ Technologies – a company that looks to revolutionize cancer treatment by producing and selling micro-fluidic assays (drug-testing environments) to research organizations and pharmaceutical companies.
* MEMStim – an original design manufacturer selling MEMS electrode leads to medical device companies for integration into their targeted nerve stimulation devices.
* ReGenerate – a company that designs, markets and leases on-site anaerobic digesters to food service operators to transform unwanted and costly organic waste into a renewable source of energy and nutrient-rich compost.
* Reveal Design Automation – a technology provider that solves the chip verification scalability challenge, enabling chip design firms to eliminate more bugs in more complex designs with less time and with fewer people.
* STIgma Free – a point-of-care medical diagnostics firm focused initially on the rapid diagnosis of sexually transmitted infections (STIs).
* SurveyBroker – a website that will match businesses and consultancies with survey fieldwork companies that can best meet their market research needs.
* Thoosa – an international freight brokerage specializing in container shipments that identifies the best shipping options in terms of ocean carrier availability, cost, service level, and carbon production rates.
Many teams go on to participate in national intercollegiate competitions, where they often earn enough seed funding to fuel the initial stages of business growth and at times, attract sizable Series A investments. During 2009-2010, Michigan teams alone took home $464,000 in prize money at intercollegiate and U.S.-based competitions.
“The support and mentorship provided throughout the competition proved critical in turning an innovative technology into a promising business with real market potential,” said Scott Hanson, a post-doctoral Fellow at the College of Engineering and CEO of Ambiq Micro, winner of the Pryor-Hale Award for Best Business at the 2009-2010 Michigan Business Challenge which has since closed a seed round of funding from DFJ Mercury Venture Partners. “The initial prize money, coupled with the opportunity to hone our investment presentation skills on the national business plan competition circuit, were essential to get our business off the ground and take it to the next level.”
The semi-final and final rounds of the competition are being held on Friday, Feb. 18, and will award over $60,000 in prize money to participating teams. The competition awards presentation and Dare to Dream Grant recipient announcement is open to the public and will take place at 5:30 p.m. at the Ross School of Business 6th Floor Colloquium. For more information on the Michigan Business Challenge and participating teams, please visit www.zli.bus.umich.edu.
About the Samuel Zell & Robert H. Lurie Institute for Entrepreneurial Studies
The Institute and its Center for Venture Capital and Private Equity Finance bring together a potent mix of knowledge, experience and opportunities from the front lines of entrepreneurship and alternative investments. The student learning experience is further enhanced through internships, entrepreneurial clubs and events that serve to provide viable networks and engage the business community. The School’s three student-led investment funds, with over $5M under management, immerse students in the business assessment and investment process. Founding Board Members include Samuel Zell, Chairman of Equity Group Investments and Eugene Applebaum, Founder of Arbor Drugs, Inc. For more information, visit the Institute at www.zli.bus.umich.edu.
SOURCE The Zell Lurie Institute
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Tufts University today announced the public launch of the Tufts Institute for Biomedical Partnerships website/HUB: www.tuftspharmapartners.org
The Institute is university-wide, global pharmaceutical partnering initiative designed to create and manage a diverse portfolio of drug discovery and development partnerships.
The Institute was developed and is managed by Tufts University School of Medicine and Tufts University’s Advancement Division.
“Our objective is to form innovative drug discovery and development alliances between Tufts and the pharma industry based on existing assets of strategic interest, while generating revenue streams to benefit the university and industry alike. To this end, we’re focused on establishing a global brand for Tufts drug discovery and development expertise,†said Lawrence J. Botticelli, Ph.D., Founder and current Chief Business Officer of the Institute.
The Institute’s website is an interactive web medium, or “HUBâ€, custom-developed and designed to educate and engage pharma partners, qualify partners and create distinctive alliances. The website functions as the Institute’s principal commercialization portal, communication vehicle, strategic market resource, and information repository. It is designed to facilitate a distinctive approach to raising industry knowledge and awareness of Tufts’ established expertise and the formation of important strategic alliances. Current information in the HUB includes five thematic areas of expertise derived from five different schools and one center. The site provides immediate access to nearly 60 research activities driven by more than 50 participating faculty members with navigable information in more than 300 categories.
“The creation of the HUB and the Tufts Institute for Biopharmaceutical Partnerships represents a landmark event and presents an exciting opportunity to those of us engaged in the discovery and innovation process,†said Ira Herman, Ph.D., Professor and Director of the Program in Cellular and Molecular Physiology, Center for Innovations in Wound Healing Research at Tufts University School of Medicine. “We hope that this new portal will enable us to establish meaningful partnerships focused on delivering novel therapeutics and cutting edge technologies, as well as significantly extend current standards of care and clinical practice, locally and globally.â€
In his recent review of the website/HUB, David Damassa, Ph.D., Dean, Information Technology, Tufts University School of Medicine, commented, “The recently-published Institute for Biopharmaceutical Partnerships website, with its innovative Global Pharma Strategy & Project Development HUB, is a wonderful new resource benefitting both the global pharmaceutical industry and Tufts University. The design of the site and its theme areas of “Discover | Collaborate | Innovate†truly capture the unique culture of Tufts University… Particularly compelling are the advanced search features of the HUB and its ability to create individual profiles so that use can be proactively connected with research and people of interest. The new site will undoubtedly raise industry knowledge and awareness of Tufts’ established expertise and ability to form strategic alliances with industry, resulting in the development of important new drugs and technologies.â€
The Institute website/HUB introduces the pharma industry to a range of thematic areas of drug discovery and development expertise:
 Innovative Therapies (Cancer, Infectious Disease, Cardiometabolic and Pulmonary Disorders, Neurological and Psychiatric Disorders),
 Technology Platforms (Biomaterials and Biological scaffolding, Genetics, Genomics and Cell Function, Translational and Clinical Pharmacology, Functional Tissue Engineering, Functional Proteomic Screens)
 Discovery & Development Services (Target Identification and Validation, Structural and Chemical Biology-Based Drug Design, Metabolic Analysis of Drug Candidates, In Vitro Models of Drug Transport, Experimental and Spontaneous Models of Disease),
 Drug Development Science (Drug Disposition and Clinical Pharmacokinetics, Clinical Pharmacology, Drug Development and Regulation, Protocol Design and Complexity, New Models of Pharmaceutical Innovation, Pharmaceutical Economics)
 Research Constellations (Establishment of non-traditional networks of robust research activities, including Regenerative Medicine, Biology and Aging, and Inflammation).
“The website/HUB is not simply an electronic repository of individuals, but a cogent, strategic expression of potential commercialization opportunities,†said Dr Botticelli.
Researchers and companies interested in learning more about the University’s drug discovery and development capabilities and how best to enter into a collaborative relationship with Tufts, can access information by navigating through the introductory “Institute†overview and learn about the Institute’s focus, leadership, business model, and research, technology, and science, as well as research constellations that it represents. Upon entering the “HUB,†users can obtain relevant information regarding therapeutic areas, technology platforms, discovery and development services, drug development science, and robust non-traditional research networks, including specific Tufts University practitioners engaged in such activities. Under “Faculty Member Profiles†detailed information on principal investigators can be obtained, including biosketches, areas of research interest, intellectual property estates, industry experiences, and relevant scientific publications.
About Tufts University School of Medicine and the Sackler School of Graduate Biomedical Sciences
Tufts University School of Medicine and the Sackler School of Graduate Biomedical Sciences at Tufts University are international leaders in innovative medical education and advanced research. The School of Medicine and the Sackler School are renowned for excellence in education in general medicine, biomedical sciences, special combined degree programs in business, health management, public health, bioengineering and international relations, as well as basic and clinical research at the cellular and molecular level. Ranked among the top in the nation, the School of Medicine is affiliated with six major teaching hospitals and more than 30 health care facilities. Tufts University School of Medicine and the Sackler School undertake research that is consistently rated among the highest in the nation for its effect on the advancement of medical science.
FDA throws curve to new diet drug
WASHINGTON, D.C.; February 6, 2011 (WPVI) –– A few weeks ago, it appeared a new diet drug combo could be in pharmacies by spring.
However, the Food and Drug Administration has reversed the decision of its expert panel, and put a hold on the drug Contrave until more tests could be done.
The delay runs the risk of quashing development of the drug entirely, by draining the financial resources of the small company developing it.
In its ruling, the Food and Drug Administration expressed concerns abvout the heart side effects of Contrave.
Contrave, which combines an anti-addiction drug to suppress appetite with an antidepressant, was the most promising in a class of new diet drugs. Several others in that field have already been rejected.
Temple University’s Center for Obesity Research and Education led local trials of the drug. And officials there were impressed with its performance. Four out of 10 patients taking Contrave for a year lost at least 5 percent of their body weight. Those results narrowly met FDA’s guidelines for effectiveness.
The FDA’s ruling was its third rejection of a weight loss drug in recent months, raising questions about whether ANY weight loss drug will pass agency muster.
For Orexigen, the FDA rejection touched off a stock market sell-off which wiped out three-quarters of the company’s market value. the cardiac tests can take years to conduct, and will cost millions of dollars. However, company executives say they want to cooperate with the FDA, to get Contrave approved.
Bristol-Myers Squibb Says FDA Approves Labeling Update For REYATAZ Capsules
(RTTNews) – Bristol-Myers Squibb Co. (BMY: News ) announced that it has received approval by the U.S. Food and Drug Administration or FDA for an update to the labeling for REYATAZ to include dose recommendations in HIV-infected pregnant women.
In HIV combination therapy, treatment with the recommended adult dose of REYATAZ 300 mg, boosted with 100 mg of ritonavir, achieved minimum plasma concentrations during the third trimester of pregnancy comparable to that observed historically in HIV-infected adults, the company noted.
Bristol-Myers added that REYATAZ should be used during pregnancy only if the benefit outweighs the risk and HIV-1 strains are susceptible to atazanavir. REYATAZ should not be used without ritonavir in pregnant or postpartum women.
Atazanavir has been evaluated in a limited number of women during pregnancy and postpartum and available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate, the company said.
Health Robotics Re-Enters the Italian Market With its World-Leading Robotics and Software Automation Tools
BOZEN, Sud-Tirol, Italy, February 7, 2011 /PRNewswire/ — Health Robotics today announced that it recently decided to re-start sales and service operations in Italy, after a three-year absence in connection with a prior agreement with Gruppo Loccioni. With over 60 hospital customers under contract carried forward from the company’s 2006-2007 presence in the Italian market, Health Robotics is on the brink to replicate its worldwide success within its home country of Italy. The company’s All-Digital solutions, including Oncology Care, will continued to be showcased at its pre-2008 installations: Campus Biomedico University Hospital, La Maddalena Cancer Center, Ospedale di Treviso, Gruppo Auxologico in Milan, and Bolzano General Hospital.
“Everybody at Health Robotics is quite excited about the prospects of finally returning to our home market, housing over 70% of our employees, and the genesis of our Research and Development Center and new factory operations in Trieste. I look forward to building in Italy a marketing and service channel strategy that rivals the unprecedented success we have already experienced in America, Middle-East, Asia-Pacific, and rest of the European Union. Additionally, it is indeed rewarding that many representatives of the Italian Hospital Pharmacy Sector have expressed their relief that Health Robotics returns to support their unmet needs. After 3 years of focusing on worldwide expansion and new product development, the late-2010 expiration of the prior agreement to temporarily assign Italian market operations to Gruppo Loccioni makes possible our return home,” stated Gaspar DeViedma, Health Robotics’ Executive Vice President.
Starting with the hosting of an Open House Event this Spring, and culminating with our July 2011 Annual Worldwide Training, both to be held in Trieste’s Area di Ricerca [Research and Development Park], Health Robotics will shortly select a combination of regional direct sales, local agents, and medical distributors amongst some of the well-established Italian medical equipment regional and national specialists that have already expressed strong interest in representing our unique robotics and software automation solutions and filling the void in the market. Health Robotics expects to quickly re-establish the Italian market momentum in the IV Robotics Sector to pre-2008 levels.
About Health Robotics:
Health Robotics is the undisputed global leading supplier of life-critical intra-venous medication robots, providing over 170 hospital installations in 5 continents with robotics technology and software automation solutions deployed utilizing virtual high-availability technology. Its world-leading solutions CytoCare(R) [hazardous IVs], i.v.STATION(R) [non-hazardous IVs], i.v.SOFT(R) [workflow engine for manual compounding], MEDarchiver(R) [life-critical clinical information system], and TPNstation(TM) [totally-automated parenteral nutrition] have and will greatly contribute to ease hospitals’ growing pressures to improve patient safety, increase throughput and contain costs. Through the effective and efficient production of sterile, accurate, tamper-evident and ready-to-administer IVs, Health Robotics’ solutions help hospitals eliminate life-threatening drug and diluent exchange errors, decrease other medical mistakes and sterility risks, work more efficiently, reduce waste and controlled substances’ diversion, and diminish the gap between rising patient volume/acuity and scarce medical, nursing, and pharmacy staff. For more information, please visit: http://www.health-robotics.com
Josephine Martin Joins PhRMA as Exec VP of Public Affairs
WASHINGTON, Feb. 7, 2011 /PRNewswire-USNewswire/ — The Pharmaceutical Research and Manufacturers of America (PhRMA) today announced that Josephine Martin has been named Executive Vice President of Public Affairs, effective March 1, 2011. Martin will report directly to PhRMA President and CEO John J. Castellani.
In her new role, Martin will be responsible for leading and managing PhRMA’s communications and alliance development functions. She comes to PhRMA from Ketchum, where she served as Senior Vice President, Public Affairs.
“We are thrilled to have Josie join our team at PhRMA. She brings extensive and successful experience in DC public affairs – with a particular strength in health policy communications,” Castellani said. “We all look forward to working with her in the years ahead to best position the biopharmaceutical sector during a critical juncture of challenge and opportunity.”
“There are few if any American industries that positively impact people’s lives in so many ways – from improving health and productivity to providing good jobs to strengthening local and national economies – as the biopharmaceutical sector,” Martin said. “I am excited to join such an energized, impactful organization as PhRMA, and I relish the chance to bring my experience to bear as we work to best convey the tremendous value of this innovative sector.”
Prior to building a health care practice and team at Ketchum, Martin served in leading public affairs positions at Golin Harris and National Media, Inc. Earlier in her career, she gained in-depth health policy communications experience as Senior Vice President, Public Affairs for the Federation of American Hospitals, and Vice President of Communications at the American Red Cross.
Martin began her career on Capitol Hill, serving as communications director and press secretary for the Senate Finance Committee and Senator John Chafee.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $45.8 billion in 2009 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.3 billion in 2009.
PhRMA Internet Address: http://www.phrma.org
ConvaTec Announces New Appointments to Leadership Team
Changes Align with Company’s Commitment to Growth
SKILLMAN, N.J., Feb. 7, 2011 /PRNewswire/ — ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, today announced the appointment of several executives to new positions within the company.
Nino Pionati has been appointed President, Intercontinental in a newly aligned region that will include Asia Pacific, Latin America and Canada. These markets continue to be a strategic focus for growth for the company. He will continue as a member of the Executive Committee and will serve as the Executive Sponsor for the company emerging markets growth initiatives.
Jorgen Hansen has been appointed Senior Vice President, Global Marketing and Business Development. In his role, Hansen will be responsible for expanding access to, and commercialization of, critical innovations to drive growth. Hansen will serve as a new member of the Executive Committee.
Robbie Heginbotham has been named interim Vice President, Global Manufacturing and Supply Chain following the departure of Cheryl Capps. In this role he will focus on developing best-in-class quality and service initiatives while maximizing operational effectiveness of the global manufacturing process and network. Heginbotham will act as an interim member of the Executive Committee.
“I am confident that these changes in leadership will help to further accelerate our growth and maintain our agility and responsiveness to the ever-changing market needs,” stated David Johnson, CEO, ConvaTec. “Each of these leaders brings a tremendous depth of experience and knowledge to their important new roles.”
About ConvaTec
ConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key focus areas – Ostomy Care, Wound Therapeutics, Continence and Critical Care, and Infusion Devices – ConvaTec products support healthcare professionals from the hospital to the community health setting. For more information, please visit www.convatec.com.
Contacts
Nimisha Savani
ConvaTec
908-904-2522
nimisha.savani@convatec.com
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FDA Orders Postmarket Surveillance of Certain TMJ Implants
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Agency wants data on length of time before removal, replacement
SILVER SPRING, Md., Feb. 7, 2011 /PRNewswire-USNewswire/ — Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.
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The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.
The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, make all of the currently approved TMJ devices marketed in the United States. The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.
TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy.
The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.
The FDA is not recommending any changes on use of the implants. The agency may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies. Patients who have or are considering a TMJ implant should consult with their health care professional.
TMJ implant manufacturers were required to collect postmarket data on their implants as part of the approval process. However, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.
The TMJ implant postmarket surveillance studies must address the following:
* Time between initial implant and removal/replacement
* Association between patient diagnosis and the timeframe between implant and removal/replacement
* For replacement implants, the time between implant and subsequent removal/replacement
* Reasons for removal/replacement of the implant
* Associations between patient demographic and clinical data and the need or removal/replacement
* Assessment of devices that have been removed from patients
As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.
For more information:
522 Postmarket Surveillance Studies
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
522 Postmarket Surveillance Studies – Frequently Asked Questions
Danaher to Acquire Beckman Coulter, Inc.
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ORANGE COUNTY, Calif., Feb. 7, 2011 /PRNewswire-FirstCall/ — Beckman Coulter, Inc. (NYSE: BEC), a leading developer, manufacturer and marketer of products that simplify, automate and innovate complex biomedical testing, and Danaher, a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers, announced today that they have entered into a definitive merger agreement under which Danaher will acquire all of Beckman Coulter’s outstanding common stock for $83.50 per share in cash (without interest), representing an approximate 45% premium over the closing price of Beckman Coulter’s common stock on December 9, 2010 before rumors of an acquisition entered the marketplace. The transaction is valued at approximately $6.8 billion, including debt assumed and net of cash acquired.
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An affiliate of Danaher is expected to commence a tender offer (the “Offer”) for all of Beckman Coulter’s outstanding common stock within the next seven business days and will remain open for a minimum of 20 business days following commencement of the Offer. The Offer is expected to be conditioned upon, among others, at least a majority of the outstanding Beckman Coulter shares being tendered, as well as the satisfaction of other customary conditions. The transaction is structured as a tender offer for all outstanding shares of Beckman Coulter followed by a merger. Approval of the transaction by Danaher shareholders is not required. The transaction is expected to be completed in the first half of 2011.
Bob Hurley, Beckman Coulter’s President and Chief Executive Officer, said, “Following a very comprehensive and competitive process, the Board of Directors voted unanimously to accept Danaher’s proposal. We believe this transaction maximizes Beckman Coulter shareholder value while strengthening the company’s position as a leader in biomedical testing to the benefit of our customers and their healthcare patients around the world. Our company’s rich history, strong brand, broad product portfolio and long-standing customer relationships are major sources of value in the transaction, enabling us to leverage our global commercial infrastructure and installed base to expand opportunities in both mature and emerging markets around the world. Longer term, we will have significant opportunities to leverage our relationships across our large installed base of automated systems in hospital laboratories with that of Danaher.”
Beckman Coulter would become part of Danaher’s Life Sciences & Diagnostics segment, joining Danaher’s Leica, AB Sciex, Radiometer and Molecular Devices businesses.
Danaher’s President and CEO, H. Lawrence Culp, Jr., said, “Beckman Coulter is an iconic company with a great brand, broad reach and technology leadership; well positioned in the markets it serves. Beckman provides an excellent complement to our existing Life Sciences & Diagnostics businesses. Being part of Danaher, Beckman associates will have the opportunity to leverage the power of the Danaher Business System, including the processes by which Danaher accelerates growth through new product innovation and driving sales, marketing and service, as well as its strength in continuously expanding margins.”
Advisors
Goldman, Sachs & Co. is acting as financial advisor to Beckman Coulter in connection with the transaction. Latham & Watkins, LLP is serving as legal counsel to Beckman Coulter in connection with the transaction.
Investor Webcast Event
Danaher will host a conference call to discuss the transactions on February 7, 2011 at 8:30 AM ET. The U.S. dial-in number is 800-967-7134; the international dial-in number is 719-325-2490; with reference ID Code 3770892. A telephone replay will be available by dialing 888-203-1112 in the US; and 719-457-0820 internationally; with ID Code 3770892. The replay will be available through February 14, 2011. The conference call and replay will also be available via webcast in the Investor section of www.danaher.com.
Optimer Pharmaceuticals and Astellas Announce Collaboration to Commercialize Fidaxomicin for Clostridium difficile infection (CDI) in Europe and Certain Other Countries in Middle East, Africa and CIS
Helix Medical to Open a New Manufacturing Facility in Costa Rica
CARPINTERIA, Calif., Feb. 7, 2011 /PRNewswire/ — Helix Medical, LLC, a global manufacturer for the medical device and healthcare industries, will soon begin construction on a new medical manufacturing facility in Costa Rica. Helix Medical signed a leasing agreement in The Coyol Free Trade Zone and Business Park in Alajuela, Costa Rica, just outside of San Jose. The company will invest more than $4M in the new plant that will soon employ more than 100 people. Helix Medical expects this new facility to begin production in the first quarter of 2012.
“We chose Costa Rica to be close to our customers in Latin America,” said Andy Becker, Vice President and General Manager, Carpinteria and Costa Rica at Helix Medical, LLC. “The country offers a large medical device community with a skilled workforce as well as a good reputation for security and infrastructure.”
Helix Medical Costa Rica will offer contract manufacturing services which include silicone extrusion, silicone molding, thermoplastic molding, and assembly operations. Additionally, the facility will be ISO 13485 certified with Class 7 & 8 cleanrooms.
About Helix Medical, LLC
Helix Medical, a division of the Freudenberg Group, is a global custom manufacturer for the medical device, pharmaceutical, biotech, and IVD industries with six manufacturing operations worldwide. Medical manufacturing capabilities include silicone and thermoplastic molding and extrusions, complex catheter systems, assembly, packaging, and engineering services. Helix Medical operates an FDA-registered medical device facility, certified ISO 13485 with Class 7 & 8 cleanrooms. Established in 1984 and headquartered in Carpinteria, California, Helix Medical currently manufactures in California, Massachusetts, Germany, Ireland, and China.
www.helixmedical.com
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Optimer Eligible to Receive Milestone Payments of up to $224 Million including $68 Million Upfront Cash Payment, and Double-Digit Royalties on Sales in the Territory
Optimer to Host Conference Call Today at 6:00 a.m. Pacific Time (9:00 a.m. Eastern Time)
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SAN DIEGO & STAINES, England, Feb. 7, 2011 /PRNewswire/ — Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) and Astellas Pharma Europe Ltd. (“Astellas”) announced today the signing of an exclusive collaboration and license agreement to develop and commercialize fidaxomicin, an investigational antibiotic for CDI, in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (CIS).
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In return for an exclusive license to fidaxomicin in the territory, Astellas is obligated to pay Optimer an upfront cash payment of approximately $68 million. Optimer is also eligible to receive additional cash payments totaling up to approximately $156 million upon the achievement of certain regulatory and commercial milestones. Furthermore, Astellas is obligated to pay tiered double-digit royalty payments on net sales of fidaxomicin in the Territory. Astellas will be responsible for all future costs associated with the development, manufacturing, and commercialization of fidaxomicin in the territory including the costs of the ongoing Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
“We believe the combined strengths of Astellas’ world-class anti-infective business capabilities, including established relationships with payers and hospitals in Europe and certain other markets, combined with Optimer’s novel therapeutic for CDI, represents the most effective way to address a serious, unmet health need,” said Mr. Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd. “We look forward to bringing fidaxomicin to these markets to help patients and providers address this serious life threatening disease.”
“We expect the Astellas collaboration will help Optimer realize the full potential of fidaxomicin and will help position this medication in these countries as the first line of treatment, both for treating CDI and reducing recurrences,” said Pedro Lichtinger, Optimer’s President and CEO. “CDI poses a significant cost burden on the healthcare system and we believe, if approved, fidaxomicin will provide a cost-savings opportunity for hospitals and payers, especially when used in populations at risk of recurrence such as the elderly, patients with a prior episode, those taking concomitant antibiotics, immuno compromised patients or those with renal impairment.”
Fidaxomicin is an orally administered macrocyclic antibiotic with a new mechanism and narrow spectrum of action being developed for the treatment of CDI. In two Phase 3 trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. Most importantly, fidaxomicin was statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47%. The New England Journal of Medicine has published results from the first Phase 3 trial in an article titled, “Fidaxomicin versus Vancomycin for Clostridium difficile Infection,” which appeared in the February 3, 2011 issue. Optimer has filed marketing applications in the U.S. and the EU for fidaxomicin.
Optimer’s exclusive financial advisor for this transaction was J.P. Morgan Securities LLC while Cooley LLP was its legal advisor. Astellas’ legal advisor in the transaction was Wragge & Co LLP.
Scheduled Conference Call
Optimer will host a conference call today at 6:00 a.m. Pacific Time (9:00 p.m. Eastern Time) to discuss this announcement. To participate in the conference call, please dial (877) 280-7280 from the U.S., or (678) 825-8232 for international callers. Please specify to the operator that you would like to join “Optimer’s Conference Call.” The conference call will be webcast live under the Investors section of Optimer’s website at www.optimerpharma.com, where it will be archived for 30 days following the call. Please connect to Optimer’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Clostridium difficile Infection (CDI)
Clostridium difficile infection, commonly referred to as “C. difficile” or “c-diff”, has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S. It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.
Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.
Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The increasing incidence of CDI, along with higher rates of both treatment failures and recurrences with current therapies have resulted in greater awareness and concern about CDI among medical professionals and public health officials. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.
About Astellas
Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 3,900 staff across these regions. For more information about Astellas Pharma Europe, please visit www.astellas.eu.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvelâ„¢ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection. The FDA granted Optimer’s request for a six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Optimer has also filed a MAA with the European Medicines Agency (EMA) for fidaxomicin. Pruvelâ„¢ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Fuisz Pharma Announces Patented Communication of Analyte Information Between Microchip Containing Smart Tablet and a Body Fluid Analyzer
MIAMI, Feb. 7, 2011 /PRNewswire/ — Based on U.S. Patent 7,824,612 (“Body Fluid Analyzer and System including Same and Method for Programming Same”), Fuisz Pharma today announced the use of their patented Technology to create a new class of microchip containing smart tablets that communicate with personal body fluid analyzers.
These tablets wirelessly inform a body fluid analyzer of acceptable analyte values for body fluids, set by the drug company so that the analyzer can provide alerts where the patient’s results exceed a threshold value.
Joseph Matus Fuisz, CEO of Fuisz Pharma, states, “We are seeing extraordinarily exciting developments around the use of microchip enabled smart tablets that can wirelessly communicate pertinent information to receiving devices. At the same time, we are seeing further growth in the capabilities of personal body fluid analyzers and a greater appreciation for their use in drug development and personalized medicine. Thus, we see the use of our patent 7,824,612 to enable the value added connection of tablet smart chips together with personal analyzers to convey a broad spectrum of pertinent information. This enhances the function of smart tablets and analyzers alike.”
About Fuisz Pharma:
Fuisz Pharma (www.fuisz.com) is a private pharmaceutical technology company originated by the Fuiszes. The Fuiszes have made substantial contributions in drug delivery including orally dissolving tablets and novel particle coating systems at Fuisz Technologies; inventing and developing thin film drug delivery technologies at Kosmos Pharma and MonoSol Rx, as well as independently developing extruded sheet technology, and have extensive experience working with big and specialty pharma.
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General Dynamics Plans to Collaborate with McKesson for a Military Electronic Health Record Solution
FAIRFAX, Va., Feb. 4, 2011 /PRNewswire/ — General Dynamics Information Technology, a business unit of General Dynamics (NYSE: GD), has entered into a letter of intent with McKesson Provider Technologies to collaborate in offering an Electronic Health Record (EHR) solution known as the “Way Ahead” to the Department of Defense (DoD). The EHR solution can be used by each military service to maintain a centralized record for its medical beneficiaries and provides for a seamless transition from legacy systems and rapid incorporation of future innovations.
McKesson Provider Technologies (MPT) is part of McKesson Corporation, a healthcare services and information-technology company and a leading provider of commercial EHR, patient/physician connectivity and health information exchange (HIE) solutions.
General Dynamics plans to leverage its systems integration expertise and DoD medical information-technology knowledge to develop a comprehensive, consolidated solution for DoD healthcare providers. The companies can deploy, sustain and support the distinct EHRs worldwide for dispersed personnel.
“The ability of the Department of Defense to provide a centralized electronic health record for its medical beneficiaries will streamline and improve healthcare by reducing testing, minimizing surgery and avoiding deadly drug interactions,” said Dan Johnson, president of General Dynamics Information Technology. “General Dynamics’ experience supporting the Medical Communications for Combat Casualty Care (MC4) program allows us to combine the proven capabilities of McKesson’s EHR solution with the systems integration and IT operations and maintenance expertise needed for optimal deployment in DoD facilities.”
“As the largest provider of healthcare services and IT, McKesson has deep expertise in what’s required to deploy clinical systems, drive adoption and improve outcomes, and we believe our knowledge can benefit the military health community,” said James Walsh, senior vice president at McKesson. “Through the proposed relationship with General Dynamics, we are excited about the opportunity to offer a single solution with the capability to modernize how the DoD provides care to its millions of beneficiaries.”
McKesson Provider Technologies is part of McKesson Corporation, currently ranked 14th on the FORTUNE 500. McKesson is a healthcare services and information technology company dedicated to helping its customers deliver high-quality healthcare by reducing costs, streamlining processes, and improving the quality and safety of patient care. Over the course of its 178-year history, McKesson has grown by providing pharmaceutical and medical-surgical supply management across the spectrum of care; healthcare information technology for hospitals, physicians, homecare and payers; hospital and retail pharmacy automation; and services for manufacturers and payers designed to improve outcomes for patients. For more information on McKesson, visit http://www.McKesson.com.
For more information about General Dynamics Information Technology, please visit www.gdit.com.
More information about General Dynamics is available online at www.generaldynamics.com.
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The Zacks Analyst Blog Highlights: Roche Holdings Ltd., Eli Lilly & Co., Bristol-Myers Squibb Co., Genzyme Corp. and GlaxoSmithKline plc.
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CHICAGO, Feb. 4, 2011 /PRNewswire/ — Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Roche Holdings Ltd. (RHHBY), Eli Lilly & Co. (LLY), Bristol-Myers Squibb Co. (BMY), Genzyme Corp. (GENZ) and GlaxoSmithKline plc (GSK).
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Here are highlights from Friday’s Analyst Blog:
Roche Misses on Tamiflu Decline
Roche Holdings Ltd.’s (RHHBY) earnings increased 7.81% to $3.07 per share for the fiscal year 2010, but fell short of the Zacks Consensus Estimate of $3.22. However, revenues for the year declined 0.8% to $45,642 million and even missed the Zacks Consensus Estimate of $47,844 million.
Despite lower revenues, earnings went up due to a decline in research and development expenses.
Revenues for 2010 experienced a decline due to lower Tamiflu sales, the impact of health care reform and European pricing pressure.
Annual Details
Roche records revenues under two segments – Pharmaceuticals Division and Diagnostics Division.
The Pharmaceuticals Division sales declined 2% primarily reflecting a considerable reduction in Tamiflu (73%) sales, decline in CellCept (15%) sales due to loss of US patent protection in May 2009, US health care reforms, European austerity measures and price cuts in Japan. These factors more than offset the robust growth of Avastin (9%), MabThera/Rituxan (9%), Herceptin (7%), Xeloda (17%) and Tarceva (6%). Sales of newly launched drugs like Actemra/RoActemra (up 177%), Mircera (up 51%) and Lucentis (up 27%) also helped boost revenues in 2010.
The conclusion of the influenza A (H1N1) pandemic, a relatively mild influenza season and the completion of most government stockpiling orders resulted in the fall of Tamiflu sales.
We note that the Pharmaceuticals Division is on track to achieve pretax annual synergies of about 1 billion Swiss francs from the Genentech merger by the end of 2011. Roche has already achieved synergies of over 800 million Swiss francs in 2010.
Revenues from the Diagnostics Division shot up 8%, with an 11% increase in the Professional Diagnostics segment and a 4% growth in the Diabetes Care segment.
Roche’s operating profit increased 7%, driven by cost synergies from the Genentech integration and productivity improvements. Operating profit margin increased 170 basis points to 34.9% for fiscal 2010.
The company plans to pay a dividend of 6.60 Swiss francs per share for 2010.
Outlook for 2011
In addition to releasing 2010 results, the company also provided a projection for 2011. For 2011, Roche expects total revenue and revenues from the Pharmaceuticals Division to grow at low single-digit rates. The growth rate excludes revenues from Tamiflu but includes the impact of US health care reform and European pricing pressure.
While Pharmaceuticals sales are expected to grow in line with the market, sales from the Diagnostics segment are expected to surpass the market. The performance of the Diagnostics segment is expected to be driven by the launch of new products.
Roche anticipates earnings and dividend for fiscal 2011 to grow at a high single-digit rate.
Further, Roche expects to reduce debt progressively and return to a net cash position by 2015.
Operational Excellence Program
The Operational Excellence Program is expected to generate annual savings worth 1.8 billion Swiss francs in 2011 and 2.4 billion Swiss francs from 2012 onwards. During the course of the implementation of the program (2010 to 2012), Roche expects to incur restructuring costs of 2.7 billion Swiss francs, which includes cash-related costs worth 1.5 billion Swiss francs.
During 2010, the company incurred 1.3 billion Swiss francs related primarily to severance payments and impairments of intangible assets. Of this, the Pharmaceuticals Division accounted for 1.2 billion Swiss francs and the Diagnostics Division accounted for the balance.
Roche, which competes with companies like Eli Lilly & Co. (LLY), Bristol-Myers Squibb Co. (BMY), Genzyme Corp. (GENZ) and GlaxoSmithKline plc (GSK), currently carries a Zacks #3 Rank (short-term Hold rating).
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Medisafe 1 Technologies Corp. Announce Significant Progress on the Discussions With The State of Israel’s Nationwide Blood Banks to Adopt Medisafe 1 Technologies Corporation’s Pre-Matching Drug Safety Administration Technology
JERUSALEM, February 4, 2011 /PRNewswire-FirstCall/ — Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today a significant progress on the discussions to implement the company’s safety pre-matching locking device technology for blood transfusion vials with Israel’s national Emergency Medical Services Provider who oversee the entire Nation’s Blood Banks.
Israel’s Magen David Adom, or Red Shield of David, is the international equivalent of the Red Cross or Red Crescent. Magen David Adom are responsible for and overlook all of the national blood banks that provide blood to Israeli hospitals and other Medical Clinics in Israel.
Discussions are to focus on implementing Medisafe 1 Technology’s patented pre-matching safety locking device on blood bags and vials. Using the technology, a barcode reader would need to electronically confirm that a particular patient was being administered the appropriate and correct blood type prior to the release of the blood from the vial .
Medisafe 1 have had similar discussions with blood banks in the United States.
“We are hopeful that the future implementation of the technology in Israel Blood Banks will lead to its implementation in other countries,” said Jacob Elhadad, CEO of Medisafe 1 Technologies.
Medisafe 1 Technologies has already developed its locking device technology for syringes in hospitals. It is estimated that the application of the technology for infusion bags will be ready for demonstration within three months’ time.
About Medisafe 1 Technologies
Medisafe 1 Technologies seeks to effectively prevent unauthorized administration of a drug or medicinal substance by hypodermic needle. Medisafe’s patented technology is a medical assembly with a locking mechanism that is intended to ensure the substance cannot be released from the hypodermic needle without positive pre-matching between the substance and its intended patient.
Forward-Looking Statements
This letter contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended and Section 21E of the Securities Exchange Act of 1934 as amended. All forward-looking statements are inherently uncertain, based on current expectations and assumptions concerning future events or future performance of Medisafe 1 Technologies Corp., and its technologies. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release, as actual results may differ materially from those indicated. Medisafe 1 Technologies Corp. public filings may be viewed at http://www.sec.gov.
Contact: Jacob Elhadad CEO +972-524440000 Jacob.elhadad10@gmail.com
Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 Count, Lot Numbers T150G10B, T120J10E and T023M10A
HUNTSVILLE, Ala., Feb. 5, 2011 /PRNewswire/ — Qualitest Pharmaceuticals today issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.
As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naive patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
No injuries have been reported to date.
Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.
The recall includes the following products:
* Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
* Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
These lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are large (approximately 16.5 mm in length), pink, capsule-shaped tablets, debossed (3600) on one side, and debossed (V) on the reverse side; Phenobarbital Tablets are small (approximately 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Phenobarbitol manufactured by Qualitest, are asked to double check the identity of their tablets.
Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.
Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.
Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.
* Telephone: 1-800-444-4011
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178
About Qualitest
Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com).
US Oncology Research First-in-Man Trials Expand to Dayton, Ohio
Dr. Robert Raju brings US Oncology Translational Oncology Program to Kettering Medical Center to provide cutting edge clinical trials to cancer patients
THE WOODLANDS, Texas, Feb. 3, 2011 /PRNewswire/ — US Oncology, Inc., a division of McKesson Corp. and a leading integrated oncology company, announced today that Robert Raju, MD, FACP has brought US Oncology Research to Kettering Medical Center in Dayton, Ohio. The new program, built from the ground up, expands the US Oncology Research Translational Oncology Program (TOP) which conducts trials for patients with advanced cancer. This center will also include first-in-man trials, which can lead to exciting breakthroughs in cancer research. US Oncology Research is a unique program enabling independent community-based oncologists to run cutting edge trials through one of the nation’s largest community-based cancer research networks so that patients can have access to the latest cancer therapies in their own hometown. To date, physicians participating in the US Oncology Research Network have contributed to the development of 43 drugs approved by the FDA.
(Logo: http://photos.prnewswire.com/prnh/20100517/DA06089LOGO)
“We look forward to resuming our Phase I clinical trials at Kettering Medical Center in association with the Kettering Health Network’s Innovation Center, which is dedicated to testing new technologies,” said Dr. Raju, medical oncologist, Kettering Medical Center and US Oncology Research. “This unique research program will provide patients and physicians in our community access to advanced clinical trials that are not otherwise available locally. This program is a tribute to the courageous patients who participated in our prior clinical trials, so we could learn and improve cancer care for the future.”
TOP is run by a select group of physicians who participate in Phase I research studies with US Oncology Research. Phase I trials are the beginning of clinical trial work – testing ideas and theories that could go on to save lives or improve the quality of life for patients. These innovative Phase I trials, including many first-in-man trials, will test new cancer therapies to provide novel therapeutic modalities for treatment and support to patients as early as possible. They often include the capability to examine the pharmacokinetic aspects of the investigational agent as well as the pharmacogenetic variations among different patient populations to predict response. Elements of a Phase I trial help investigators understand how a drug is absorbed, distributed, metabolized and eliminated in the body so that toxicity can be closely monitored. This information is used to help bring the trial into Phase II, the next step in proving a new therapy’s value in cancer care.
As a founding member of US Oncology TOP and a physician who has enrolled more than 50 patients to US Oncology TOP trials, Dr. Raju is looking forward to bringing cutting-edge therapies to patients in their own community. Investigators affiliated with the US Oncology Research Network are independent community-based oncologists who bring their past academic research experience to local communities across the country. The network includes thought leaders in specific tumor types including rare cancers such as pancreatic, bladder and other genitourinary tumors.
US Oncology Research Fact Sheet:
US Oncology Research is physician-led and physician-driven with a successful history of clinical depth and expertise.
Since its inception in 1992, more than 47,000 patients have participated in more than 1,100 trials through the US Oncology Research Network.
* More than 1,000 have been enrolled in Phase I trials.
* In less than two decades, US Oncology Research has played a role in the development of 43 cancer therapies approved by the FDA.
* The US Oncology Research Network includes more than 90 practices in 200 locations across the U.S.
* The network supports 14 sites that offer Phase I trials, including first-in-man trials.
* At any given time, the network has more than 90 open clinical trials and more than 200 active trials.
* Leadership at US Oncology Research consists of experts in a wide variety of cancer specialties including breast cancer, developmental therapeutics, gastrointestinal cancer, hematologic cancer, gynecologic cancer, genitourinary cancer, lung cancer, and radiation therapy.
* 66 manuscripts from investigator-initiated studies have been published in peer-reviewed journals.
* US Oncology Research supports one of the nation’s largest research networks specializing in both investigator- and sponsor-initiated Phase I-IV oncology clinical trials.
* Trials bring innovative therapies to patients in local communities across the nation.
* To find a clinical trial or to join the US Oncology Research Network or the United Network of US Oncology, visit the US Oncology website.
About US Oncology
US Oncology, Inc., a division of McKesson Corp., is a leading integrated oncology company. By uniting one of the largest community-based cancer treatment and research networks in America, US Oncology expands patient access to high-quality care and advances the science of cancer care. Headquartered in The Woodlands, Texas, US Oncology is affiliated with 1,400 community-based oncologists, and works with patients, hospitals, payers, and the medical industry across all phases of the cancer research and delivery continuum. By promoting the use of innovative technology, clinical research, evidence-based medicine and shared best practices, US Oncology improves patient outcomes and offers a better patient experience. For more information, visit www.usoncology.com.
CardioGenics to File for 510K Clearance With the United States Food and Drug Administration by Q4 2011
CardioGenics Expects to Go Head-to-Head with Analyzer Manufactured by Siemens
MISSISSAUGA, Ontario, Feb. 3, 2011 /PRNewswire/ — CardioGenics Holdings Inc. (CGNH.OB) announced today final plans for testing of its QL Careâ„¢ (QLCA) Analyzer. The data that will be collected from the testing at 4 hospitals in North America will be used as a key component of the Company’s 510K application with the United States Food and Drug Administration. The 510K application will allow the FDA to determine whether the QLCA is equivalent to another device that is currently approved by the FDA for commercialization. Upon approval of the application, CardioGenics will begin marketing the QLCA throughout the United States.
The Company has determined that it will use the Siemens ADVIA Centaur Analyzer and its related Troponin-I test as the reference standard for its clinical testing. CardioGenics has already identified four hospitals that use the Siemens ADVIA Centaur and will obtain approval from these hospitals to conduct comparative clinical testing of its QL Careâ„¢ Analyzer and Troponin-I test at their sites. The goal of this comparative testing is to confirm that the results from the CardioGenics QL Careâ„¢ Analyzers and the Siemens ADVIA Centaur systems are equivalent. CardioGenics expects to begin enrolling patients in this comparative trial upon approval of the Institutional Review Boards, which approvals it expects to receive by May 2011. The comparative trials will take approximately 45 days to complete.
Upon successful completion of clinical confirmation, the Company will then finalize protocols and commence trials for the FDA application for approval of its QL Careâ„¢ Analyzer and Troponin-I test. This final testing is expected to start during early Q3 2011 and complete two months later.
Yahia Gawad, MD, Chief Executive Officer of CardioGenics Holdings Inc. said, “Over the past few months, we have completed development of the QL Careâ„¢ Analyzer. We have solved many of the technological challenges that still affect the performance of other point-of-care devices on the market today. Our goal has always been to create test products at the point of care that compare favorably to the large and expensive lab-based machines.”
Dr. Gawad continued, “Originally, we had planned to test our device and related tests against Beckman Coulter’s Access II analyzer and their AccuTnl Troponin test kit. It is our understanding that this option is no longer available to us as, according to Beckman Coulter’s SEC filings, Beckman Coulter is in the process of resubmitting a renewed application to the FDA for commercialization. Therefore, Siemen’s product offering which is on the market was the logical choice.”
Dr. Gawad concluded, “We would like to thank our shareholders for their continued support through the development and approval process. We are glad to deliver the news of these positive developments.”
About CardioGenics Holdings Inc.
Through its operating subsidiaries, the Company develops ultra-sensitive analyzers and other products targeting the immunoassay segment of the Point-Of-Care IVD testing market. It has developed the QL Careâ„¢ Analyzer, a proprietary and ultra-sensitive Point-Of-Care immuno-analyzer, which will run a number of diagnostic tests under development, the first of which will be a series of cardiovascular diagnostic tests. As part of its core proprietary technology, the Company has also developed a proprietary method for silver coating paramagnetic microspheres (a fundamental platform component of immunoassay equipment), which improve instrument sensitivity to light. The Company’s principal offices are located in Mississauga, Ontario, Canada. For more information please visit www.cardiogenics.com.
Safe Harbor Statement – Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and may contain forward-looking statements, with words such as “anticipate, “believe,” “expect,” “future,” “may,” “will,” “should,” “plan,” “projected,” “intend,” and similar expressions to identify forward-looking statements. These statements are based on the Company’s beliefs and the assumptions it made using information currently available to it. Because these statements reflect the Company’s current views concerning future events, these statements involve risks, uncertainties and assumptions. The actual results could differ materially from the results discussed in the forward-looking statements. In any event, undue reliance should not be placed on any forward-looking statements, which apply only as of the date of this press release. Accordingly, reference should be made to the Company’s periodic filings with the Securities and Exchange Commission.
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Hospira Announces FDA Approval of Topotecan Injection
— First solution formulation of oncolytic approved in United States —
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LAKE FOREST, Ill., Feb. 3, 2011 /PRNewswire/ — Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of Topotecan Injection, the first solution formulation of the oncology drug approved in the United States. The medication is a generic version of Hycamtin®, which had 2010 U.S. sales of more than $140 million. Hospira’s topotecan is indicated for treatment of small cell lung cancer (SCLC) sensitive disease after failure of first-line chemotherapy.
The solution formulation of topotecan, with a concentration of 4 mg/4 ml, is designed to improve caregiver convenience and safety, and Hospira expects to launch the product by the end of February.
“Hospira’s solution version of topotecan expands our portfolio of value-added generics,” said Thomas Moore, president, U.S., Hospira. “We’re excited to offer the medical community access to a lower-cost, more convenient version of this key oncolytic.”
Hospira’s specialty injectable pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as ADD-Vantageâ„¢ drug delivery system and iSecureâ„¢ prefilled syringes. Therapeutic segments include analgesia, anesthesia, anti-infectives, cardiovascular, oncology, emergency and other areas. Hospira also has robust pipelines of both generic and biosimilar drugs.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellnessâ„¢. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.
Tacere Therapeutics Reacquires Rights to Develop and Commercialize its Hepatitis C Compounds in Asia
SAN JOSE, Calif., Feb. 3, 2011 /PRNewswire/ — Tacere Therapeutics, Inc., an RNA interference (RNAi)-based therapeutics company, announced today that it has reacquired the development and commercialization rights to its Hepatitis C Virus (HCV) compounds throughout Asia from its strategic partner, Tokyo-based Oncolys BioPharma Inc.
“We are very happy to have regained control of the Asian development and commercialization rights to our family of HCV compounds,” said Sara Hall Renison, Chief Executive Officer of Tacere. Mike Catelani, Chairman, President and CFO, added, “With the continued promising development of our lead HCV compound in partnership with Pfizer, holder of the non-Asian worldwide development and commercialization rights, we believe that we are well-positioned to commence regulatory activities in Asia.”
About Tacere’s family of HCV compounds
Tacere’s family of HCV compounds, are novel therapeutic products containing three separate RNAi elements targeted against the Hepatitis C virus itself and encapsidated in an adeno-associated virus (AAV) protein coat. AAV delivery methods have demonstrated clinical safety, and preclinical animal studies with TT-034, the lead compound in the family, have shown the ability to penetrate hepatocytes (the site of HCV replication) at high levels following a single intravenous administration. In preclinical animal studies, this “cocktail in one drug” monotherapy targeted and cleaved the Hepatitis C virus itself at three different sites simultaneously without toxicity.
About Tacere Therapeutics, Inc.
Tacere is an innovative biotechnology company focused on developing therapeutics to treat human diseases using its proprietary knowledge in the development of RNAi therapeutics. Tacere is located in San Jose, California, USA. For additional information, please visit www.tacerebio.com.
Onyx Pharmaceuticals Appoints Bill Ringo to Board of Directors
Selects Industry Veteran with Broad Commercial Oncology Experience
EMERYVILLE, Calif., Feb. 3, 2011 /PRNewswire/ — Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that it has named Bill Ringo to its Board of Directors. Mr. Ringo currently serves as Executive Partner at Sofinnova Ventures, a venture capital firm based in Silicon Valley and as a Senior Advisor to Barclays Capital.
“Bill’s impressive industry knowledge, commercial oncology experience and broad sector expertise will be invaluable as we look to expand our commercial presence with a potential second marketed product, carfilzomib, and continue to broaden our development pipeline,” said N. Anthony Coles, M.D., president, chief executive officer and member of the board at Onyx.
Mr. Ringo has 38 years of experience in the pharmaceutical, biotechnology and med-tech industries. Prior to his most recent assignments, he served as senior vice president of strategy and business development for Pfizer, retiring in 2010. He also spent 28 years at Eli Lilly & Company, serving as product group president for oncology and critical care, president of the infectious diseases business unit, vice president of sales and marketing for U.S. Pharmaceuticals, and as a member of the corporate operating committee. Mr. Ringo was the former president and chief executive officer of Abgenix, a biotechnology firm focused on developing human antibodies to treat cancer that was acquired by Amgen in April 2006. He is the current chairman of Sangamo BioSciences and serves as a director on the Alvine Pharmaceuticals, Inc. and BioCrossroads boards. Mr. Ringo holds a bachelor’s degree and masters in business administration from the University of Dayton.
“It is an honor to join the Board of Directors at a time when Onyx is making the transition into a leading biotechnology company with a strong commercial presence and long-term growth opportunities through its pipeline,” said Ringo. “I believe Onyx will continue to raise the bar in providing innovative and effective treatment options for cancer patients in need.”
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company’s website at www.onyx-pharm.com.
Teva gets FDA warning letter for Jerusalem plant
TEL AVIV, Feb 3 – Teva Pharmaceutical Industries (TEVA.O) has been notified in a warning letter of weaknesses at its Jerusalem oral solid dosage plant (OSD) after an inspection last year by the U.S. Food and Drug Administration.
The FDA cited deficiencies related to laboratory reporting and systems in a letter received Jan. 31, the world’s biggest generic drugmaker said on Thursday.
The FDA inspected the plant in September and then issued Israel-based Teva (TEVA.TA) observations, to which the company responded in October.
Teva said it believed it has addressed the observations and has been working to resolve FDA concerns listed in the warning letter, which does not restrict production or shipment of the company’s products from this facility.
“However, unless and until the company is able to correct outstanding issues to the FDA’s satisfaction, the FDA may withhold approval of pending drug applications listing the Jerusalem OSD facility,” the statement said.
“The FDA may also withhold permission to export products manufactured at the facility into the United States.”
Citi analyst John Boris said the facility, which manufactures 35 molecules, accounted for less than 3 percent of Teva’s estimated $16.3 billion in 2010 sales.
“After reviewing the letter, we do not expect the deficiencies to materially affect production or shipment from this facility,” Boris wrote in a clients’ note, adding he expects Teva to respond in two to three months, including a risk management plan for the facility.
The plant has 600 employees and mainly supplies North America.
“Based on IMS sales data, the two molecules cited for violations, glyburide metformin (generic Glucovance) and zolpidem tartrate (generic Ambien), accounted for 2010 sales of $18 million and $19 million, respectively,” Boris said.
