Press Releases II

Perrigo Announces Conclusion of the FDA Re-Inspection

ALLEGAN, Mich., April 12, 2011 /PRNewswire/ — Perrigo (Nasdaq: PRGO; TASE) today announced that the Detroit Office of the Food and Drug Administration (FDA) has concluded its re-inspection of Perrigo’s Allegan facility. The FDA has informed Perrigo that, effective immediately, the Company has an acceptable regulatory status, such that any pending export license and ANDA applications from this facility will once again be eligible for review and approval.

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Perrigo’s Chairman and CEO Joseph C. Papa stated, “On behalf of Perrigo, I want to thank the FDA Detroit District for making the re-inspection of our facilities a priority and for working cooperatively with us to resolve the issues previously raised in the Warning Letter. We are convinced that this process has made us a better company by enhancing the quality of our affordable healthcare products for our customers.”

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products. The Company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The Company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).

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High-Risk Medical Devices Fail to Get Adequate U.S. Scrutiny, GAO Reports

High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who donâ€™t monitor recalls when concerns arise during marketing, the Government Accountability Office found.

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The Food and Drug Administration has given expedited reviews to at least 67 devices such as pacemakers and hip joints since the GAO called in January 2009 for â€œimmediate stepsâ€ to increase standards or reclassify the potential risks, according to testimony from Marcia Crosse, the GAOâ€™s director of health care. The Senate Special Committee on Aging is scheduled to discuss the findings at a hearing today in Washington.

A series of device recalls led by Johnson & Johnson (JNJ)â€™s decision last year to pull 93,000 artificial hips from the market spurred lawmakers to scrutinize the agencyâ€™s approval process. FDA has been slow to implement a 1976 law requiring that all high-risk devices undergo a strict review. Many are still cleared with minimal tests under the so-called 510(k) program if companies prove theyâ€™re similar to existing products, said the GAO, the investigative arm of Congress.

â€œConcerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective,â€ Crosse said in written testimony for todayâ€™s hearing.

The 510(k) program, which clears about 3,800 to 4,000 products a year, is â€œcritical to a vibrant and successful device industry,â€ according to testimony for the hearing from David Nexon, senior executive vice president for the Advanced Medical Technology Association, a trade group. The process â€œhas an exemplary record of protecting the public from unsafe devices,â€ he said.
Lacking Oversight

The FDA requires extensive testing for less than one-tenth of devices. The GAO study focuses on high-risk devices, including those that are implantable or life sustaining. All but one of the 27 types of products cited in the 2009 report are still getting less-stringent reviews by the FDA, a preliminary GAO review of the process shows, Crosse said in her testimony.

Regulators also donâ€™t routinely analyze trends in device recalls or ensure that companies make promised fixes in the prescribed time frame, increasing the risk that unsafe products linger on the market, the GAO found.

Eighty-one percent of the 113 withdrawn devices deemed high-risk recalls by the FDA from 2005 to 2009 were approved under the less-stringent pathway, researchers said Feb. 14 in the journal Archives of Internal Medicine.
Heart Devices

Cardiovascular devices accounted for a third of the recalls, among them automated external defibrillators made by Minneapolis-based Medtronic Inc. (MDT), Zoll Medical Corp. (ZOLL) of Chelmsford, Massachusetts, and closely held Welch Allyn Inc., of Skaneateles Falls, New York, the researchers said. Defibrillators are devices that shock irregular or stopped hearts back into normal rhythms.

Senate Democrats say the FDA may need new authority, including mandatory device registration and recall power, to more quickly identify potential safety issues.

The FDA is conducting an internal audit of the 510(k) program and has sought the advice of the Institute of Medicine, an independent arm of the National Academy of Sciences. The agency in January announced 25 steps to improve consistency and transparency in the review process. More changes were referred to the institute, which plans to issue a report this year.

Jeffrey Shuren, director of the FDAâ€™s Center for Devices and Radiological Health, is scheduled to testify tomorrow at a separate hearing on medical device approvals with the House Oversight & Government Reform committee.
Hip-Product Failures

Among the devices recalled were 93,000 hip implants made by the DePuy Orthopaedics unit of New Brunswick, New Jersey-based J&J, including 37,000 in the U.S. In announcing the recall, J&J cited unpublished U.K. data showing that within five years as many as 13 percent of the hips failed and needed to be replaced.

Katherine Korgaokar, a J&J hip recipient, had her implant replaced after her doctor said excessive wear had released high levels of cobalt and chromium into her body, according to her written testimony for todayâ€™s Senate aging committee hearing. She said recovering from the second operation has been â€œsubstantially more difficult than the first,â€ and she may require more surgeries.

Before her implant, she thought devices were extensively tested by regulators.

â€œI had no idea that devices could be â€˜fast-trackedâ€™ by the FDA with little or no testing,â€ Korgaokar said according to her written testimony.

Precision Therapeutics’ ChemoFxÂ® Demonstrates Significant Role in Selection of Chemotherapy Doublets in Non Small Cell Lung Cancer

PITTSBURGH, April 12, 2011 /PRNewswire/ — Drs. Rodney Landreneau and Matthew Schuchert from the University of Pittsburgh presented a new non small cell lung cancer study at the 2011 Society of Surgical Oncology (SSO) conference in San Antonio, Texas. Dr. Landreneau is Director of the Lung Center at UPMC Shady Side Hospital as well as the Head of Thoracic Surgery at UPMC Passavant Medical Center and Director of the Division of Cardiothoracic Surgery at UPMC St. Margaret Medical Center. Dr. Matthew J. Schuchert is an Assistant Professor of Surgery in the Department of Cardiothoracic Surgery at the University of Pittsburgh Cancer Institute.

The study, titled, “Assessment of In Vitro Chemoresponsiveness to Platinum Based Chemotherapy Doublets Lead to Improvements in ‘Individualized’ Therapy for Resected Non Small Cell Lung Cancer (NSCLC),” demonstrates that while 35% of patient specimens evaluated in vitro are resistant to all three standard platinum doublets tested, 28% demonstrate a uniquely variable response, suggesting therefore that ChemoFxÂ® chemoresponse testing may help guide optimal selection of the platinum doublet for treatment, a factor that may be crucial to the patient’s outcome.

Christine Gan, Ph.D., a medical science liaison for Precision Therapeutics, noted, “Selecting the optimal platinum doublet for individual NSCLC patients is not straightforward when three equally efficacious options exist. ChemoFxÂ®, when used as a tool in conjunction with a physician’s clinical judgment, can potentially help guide the selection of therapy in this difficult to treat disease.”

According to recent statistics, lung cancer is currently responsible for 29% of cancer deaths in the United States, which represents more deaths than breast cancer, colon cancer, and prostate cancer combined. Lung cancer remains the leading cause of cancer deaths for both men and women.

About Precision Therapeutics

Precision Therapeutics, a life-science company based in Pittsburgh, Pennsylvania, is committed to improving outcomes of cancer patients. As leaders in the science of individualizing cancer therapy through the use of a proprietary and unique live-tissue platform, Precision develops novel markers to help guide treatment decisions based on the biological processes of each individual’s cancer.

Precision’s state of the art bioinformatics combined with the analysis of the live molecular, proteomic and genomic activity of each patient’s cancer offer an innovative foundation for further development and commercialization of novel predictive markers for cancer therapy.

ChemoFxÂ® is a proprietary drug response marker which measures an individual’s malignant tumor response to a range of standard therapeutic alternatives under consideration by a physician. Precision currently receives ChemoFxÂ® specimens from 271 top medical institutions including 20 of the 21 National Comprehensive Cancer Network (NCCN) Member Institutions, and 8 of the US News and World Report Top 10 Hospitals for Cancer Care. To date, ChemoFxÂ® Final Reports have been provided for over 56,000 patient specimens, using 105 unique chemotherapy treatments and combinations. For more information, visit www.precisiontherapeutics.com or www.chemofx.com

SOURCE Precision Therapeutics
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MiMedx Group Announces Launch of EpiFixâ„¢ and Hiring of Vice President, Wound Care

MARIETTA, Ga., April 11, 2011 /PRNewswire/ — MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products and bioimplants processed from human amniotic membrane, announced today the nation-wide launch of the Company’s latest product, EpiFixâ„¢, a biologic implant specifically processed to offer a wide variety of wound healing and wound care options. The Company also announces the hiring of Frank Burrows as its Vice President of Wound Care.

Parker H. “Pete” Petit, Chairman and CEO, stated, “EpiFixâ„¢, another of our products resulting from MiMedx Group’s proprietary PurionÂ® process, produces an allograft from amniotic tissue which is optimized for numerous wound care applications.. In our clinical studies, EpiFixâ„¢ has outperformed the competitive products.”

According to the 2010 iData report, the combined U.S. wound and tissue management market was valued to be in excess of $7.4 billion. “With the wound care market representing such a large opportunity, we have added another key executive to our organization. Effective today, Frank Burrows joins MiMedx in the newly created capacity of Vice President of Wound Care. Frank brings to MiMedx over 20 years of experience and expertise in developing and implementing sales and marketing programs that have created growth for numerous medical devices and pharmaceuticals in the areas of wound closure, wound healing, tissue engineering, and bio-active therapeutics. Frank’s expertise and in-depth command of the wound care, wound healing and tissue markets was gained through key roles at J & J Wound Management, Smith & Nephew, Advanced Tissue Sciences and Histogen Aesthetics,” added Petit.

MiMedx reported that EpiFixâ„¢ is the wound care branded tissue resulting from the Company’s proprietary PurionÂ® process. The amniotic tissue produced using the PurionÂ® Process has generated a growing demand for easy to use, minimally manipulated allografts and has experienced increased growth in the areas of ophthalmology, dental, spine and sports medicine. The Company’s tissues have been used in over 30,000 implants to date.

“Frank joins us today to spearhead the EpiFixâ„¢ launch and lead the Sales & Marketing of our wound care initiative. We have EpiFixâ„¢ inventory, and MiMedx expects EpiFixâ„¢ to generate revenues in the second quarter. Our wound care initiative, serving both civilian and military, will focus on wound care clinics, hospitals, general practice clinics, physicians and private label opportunities,” Petit said.

Bill Taylor, President and COO, stated, “With the substantial size of the market opportunity and the industry-leading amniotic tissue processing capabilities within our Surgical Biologics subsidiary, we believe that MiMedx has the potential to capture market share in multiple segments of this extremely large market. These segments include diabetic foot ulcers, bed sores, anti-scaring barriers, burn therapy, plastic surgery and several other clinical applications.”

Novartis Drug AfinitorÂ® Recommended by FDA Oncology Advisory Committee for Approval to Treat Advanced NET of Pancreatic Origin

– Committee votes unanimously in favor of everolimus to treat patients with advanced neuroendocrine tumors (NET) of pancreatic origin

– Phase III results showed everolimus more than doubled median progression-free survival from 4.6 to 11.0 months when compared with placebo in patients with advanced pancreatic NET(1)

– Everolimus represents a targeted approach for the treatment of patients with advanced pancreatic NET, for which there are limited options(1,2,3)

EAST HANOVER, N.J., April 12, 2011 /PRNewswire/ — Novartis Pharmaceuticals Corporation (“Novartis”) announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of AfinitorÂ® (everolimus) tablets for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin.

The recommendation was provided after presentation of data from the everolimus RADIANT (RAD001 In Advanced Neuroendocrine Tumors) trial program, the largest conducted in patients with advanced NET. The Phase III RADIANT-3 trial studied patients with advanced NET of pancreatic origin and showed a statistically significant improvement in progression-free survival with everolimus versus placebo(1).

The FDA can seek the advice of its advisory committees as it reviews and decides whether to approve treatments, although it is not obliged to follow the recommendation(4,5).

“We look forward to working with the FDA as it completes its review and we are encouraged by the advisory committee’s recommendation to approve everolimus for patients with advanced pancreatic NET,” said Herve Hoppenot, President, Novartis Oncology. “The study of everolimus in this patient population is an example of our commitment to identify targeted options for patients with critical unmet medical needs.”

When pancreatic NET becomes advanced, meaning the cancer has spread to other parts of the body, it is considered aggressive and difficult to treat(6). Approximately 60% of pancreatic NET patients are diagnosed with advanced disease, and the five-year survival rate for these patients is 27%(3,7).

Everolimus targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism(2). Preclinical and clinical data have established the role of mTOR in the development and progression of several types of tumors, including advanced pancreatic NET, for which there are limited treatment options(1,2,3).

Earlier this year, the FDA granted everolimus priority review designation for the application and proposed indication for the treatment of advanced NET of gastrointestinal (GI), lung or pancreatic origin. Based on feedback from the FDA, Novartis amended the proposed indication to focus on patients with one specific type of NET, advanced NET of pancreatic origin.

Priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 to six months(8). There is the potential that the outcome of an ODAC meeting could result in the FDA extending the review period.

Worldwide regulatory filings for everolimus as a treatment for advanced NET of GI, lung or pancreatic origin are being reviewed by health authorities.

About pancreatic neuroendocrine tumors (NET)

Neuroendocrine tumors arise from cells that can produce and secrete a variety of hormones that regulate bodily functions(9). These tumors can occur anywhere in the body; however, most are found in the pancreas, gastrointestinal tract or lungs(7,10). Pancreatic NET, also known as islet cell tumors, is a rare type of cancer that is different from pancreatic exocrine cancer, generally referred to as pancreatic cancer(6,11). There are currently limited treatment options for pancreatic NET patients(3).

About RADIANT-3

RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care (BSC) versus placebo plus BSC in 410 patients with advanced, low- or intermediate-grade pancreatic NET. Patients who met the study entry criteria were randomized 1:1 to receive either everolimus 10 mg once-daily (n=207) or daily placebo (n=203) orally, both in conjunction with BSC(1).

The primary endpoint of RADIANT-3 is progression-free survival (PFS). Secondary endpoints include safety, objective response rate (confirmed according to RECIST), duration of response and overall survival(1).

Results from the trial showed that everolimus more than doubled median PFS from 4.6 to 11.0 months when compared with placebo and reduced the risk of cancer progression by 65% (hazard ratio=0.35 [95% CI, 0.27 to 0.45]; p<0.001) in patients with advanced pancreatic NET(1). In the study, everolimus maintained a safety profile consistent with the prescribing information and previous studies of the drug. The most frequent all grade, drug-related adverse events (greater than or equal to 20%) were stomatitis/oral mucositis/ulcers (64% everolimus vs. 17% placebo; includes stomatitis, aphthous stomatitis, mouth ulceration and tongue ulceration), rash (49% vs. 10%), diarrhea (34% vs. 10%), fatigue (31% vs. 14%), infections (23% vs. 6%), nausea (20% vs. 18%), peripheral edema (20% vs. 3%) and decreased appetite (20% vs. 7%); most were grade one or two. Grade three and four adverse events (greater than or equal to 5%) include stomatitis/oral mucositis/ulcers (7% vs. 0%; includes stomatitis, aphthous stomatitis, mouth ulceration and tongue ulceration), anemia (6% vs. 0%) and hyperglycemia (5% vs. 2%). Median exposure to everolimus was 2.3-fold longer than exposure to placebo (38 vs. 16 weeks)(1). About Afinitor (everolimus) AfinitorÂ® (everolimus) tablets is approved in the US for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and in the European Union (EU) for the treatment of patients with advanced RCC whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. Afinitor is also approved in the US to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Afinitor is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been shown. Novartis has submitted marketing applications for everolimus for this use to the European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products (Swissmedic), and additional regulatory submissions are under way worldwide. Afinitor is available in the US in 2.5 mg, 5 mg and 10 mg tablet strengths. With once-daily dosing, Afinitor targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism. In the US, everolimus is available in different dosage strengths for the non-oncology patient population under the trade name ZortressÂ® for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. In the EU, everolimus is available in different dosage strengths under the trade name CerticanÂ® for the prevention of organ rejection in heart and kidney transplant recipients. Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents. Not all indications are available in every country. As an investigational compound the safety and efficacy profile of everolimus has not yet been established in pancreatic or any other type of NET. Access to everolimus outside of the approved indications has been carefully controlled and monitored in clinical trials designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for pancreatic or any other type of NET or any additional indications anywhere in the world. Important Safety Information for AfinitorÂ® (everolimus) tablets Patients should not take Afinitor if they are allergic to Afinitor or to any of its ingredients. Patients should tell their healthcare provider before taking Afinitor if they are allergic to sirolimus (RapamuneÂ®#) or temsirolimus (ToriselÂ®#). Afinitor can cause serious side effects including lung or breathing problems or infections. In some patients lung or breathing problems may be severe, and can even lead to death. Patients should tell their healthcare provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, difficulty breathing or wheezing. Patients may need to stop taking Afinitor for a while or use a lower dose. Afinitor may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe, and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they have a temperature of 100.5 degrees F or above, chills or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stool or dark urine, yellowing of the skin or pain in the upper right side. Afinitor can cause mouth ulcers and sores. In patients taking Afinitor for advanced kidney cancer, 44% of patients developed mouth ulcers/sores and in patients taking Afinitor for SEGA, 86% of patients developed mouth ulcers/sores. Patients should tell their healthcare provider if they have pain, discomfort or open sores in their mouth. Their healthcare provider may tell them to use a special mouthwash or mouth gel that does not contain alcohol or peroxide. Patients will have regular blood tests before they start and as needed during their treatment with Afinitor. These tests will monitor how their kidneys and liver are working, their blood sugar and cholesterol levels as well as the number of blood cells in their body. Patients who receive Afinitor for the treatment of SEGA will need regular blood tests to measure how much Afinitor is in their blood since this will help their doctor decide how much Afinitor they need to take. Afinitor may affect the way other medicines work, and other medicines can affect how Afinitor works. Using Afinitor with other medicines can cause serious side effects. Patients should tell their healthcare provider about all of the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements such as: St. John's Wort, and medicine for fungal infections, bacterial infections, tuberculosis, seizures, HIV-AIDS, heart conditions or high blood pressure and medicines that suppress their immune system. Patients should not drink grapefruit juice or eat grapefruit during their treatment with Afinitor as it may make the amount of Afinitor in their blood increase to a harmful level. Patients should not take Afinitor tablets which are broken or crushed. Patients should not chew or crush the tablets. The amount of Afinitor in the blood was increased in patients who had liver problems. Patients should tell their healthcare provider about all their medical conditions, including if they have or have had liver problems, diabetes or high blood sugar, high cholesterol levels, infections, hepatitis B or other medical conditions. Patients should tell their healthcare provider if they are scheduled to receive any vaccinations. Patients should not receive a live vaccine or be around people who have recently received a live vaccine during treatment with Afinitor. It is not known if Afinitor will harm an unborn baby. Women should use effective birth control while using Afinitor and for 8 weeks after stopping treatment. Common side effects of Afinitor in patients with advanced kidney cancer include mouth ulcers, infections, feeling weak or tired, cough and diarrhea. Common side effects of Afinitor in patients with SEGA include mouth ulcers, infections of the respiratory tract, sinuses and ears and fever. FDA Acts To Prevent Contamination Problems With Triad Antiseptic Products

Silver Spring, MD /PRNewswire-USNewswire/ – U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized more than $6 million in products distributed by Triad Group Inc., at the company’s facility in Hartland, Wis. 483 posted here.

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Triad Group and H & P Industries are owned and managed by the same parties. A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products, and raw materials.

“We took this action to stop Triad from continuing to distribute products, which may pose a risk to public health,” said Dara Corrigan, FDA associate commissioner for regulatory affairs.

The action follows the continued failure of H & P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations, which are intended to assure the safety, quality, and purity of manufactured drugs. Through this seizure, FDA seeks to prevent the company from distributing product that was manufactured in violation of federally mandated manufacturing requirements.

In connection with the seizure of the medical products and related items, the First Assistant United States Attorney for the Eastern District of Wisconsin, Gregory J. Haanstad, commended officials and staff of the Food & Drug Administration and the United States Marshals Service for their highly effective, focused, and collaborative work with the Office of the United States Attorney: “The seizures at the H & P Industries facility in Hartland reflect the continuing commitment of all federal law enforcement offices to ensure the safety and the security of our populationsâ€”and to safeguard against those whose disregard of professional obligations threaten to compromise public health and well-being.”

Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products.

FDA completed its most recent inspection of H & P Industries on March 28, 2011. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system; failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

Ningbo warning letter in line with FDA agenda

Ningbo Smart Pharmaceutical has felt the sting of an FDA warning letter over quality control problems and the company’s failure to register and list APIs it distributes in the U.S. CDER director Richard Friedman writes to company chairman Grant Wu about three violations concerning raw material and finished product testing.

There’s no doubt that the FDA is increasing foreign inspections. It conducted about 2,000 in 2010 and “evidence suggests this number will grow dramatically in FY11.”

The first two of the three concern raw materials released by the QC unit. Inspectors found that no testing was done for certain impurities and for material identity, yet documentation indicates the tests were done, and the materials met spec.

“This serious deviation raises concerns regarding the reliability and integrity of other data,” writes Friedman. He dismisses the company’s commitment to improve its quality control unit–stated in response to the Form 483 inspection report that followed the FDA visit–as inadequate to determine “the extent and impact of the problem.”

The remaining deviation cites a lack of testing in finished API lots that were released.

Serious GMP Deviations Noted in Ningbo Warning Letter:

FDA Warning Letter Text Below:

Specific deviations observed during the inspection include, but are not limited, to the following:

1. Failure of your quality unit to ensure that materials are appropriately tested and the results are reported.

For example, your Quality Control Unit (QCU) approved the release of four (b)(4) USP batches (#(b)(4)) without data to support that the test for organic volatile impurities (OVI) met release specifications.

While your Certificates of Analysis state that OVI levels conformed to specifications, the inspection found that no testing was done.

It is essential that your firm only report results to customers when you have actually performed the analysis.

This serious CGMP deviation raises concerns regarding the reliability and integrity of other data generated by your firm. While we acknowledge the commitment in your November 19, 2010 response to improve the QCU, we remain concerned that your investigation is not comprehensive enough to determine the extent and impact of the problem. A review of the (b)(4) OVI records of batches that were not previously tested is not sufficient. In your response, provide a complete corrective action plan that includes a retrospective review of the analytical data and batch records for all products manufactured at your facility that remain within expiration. In addition, provide the actions taken to prevent recurrence of the problem. Your investigation should be expanded to all other products manufactured at this site and include the establishment of a comprehensive training program for analysts and QC personnel.

2. Failure of your QCU to exercise its responsibility to ensure the APIs manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.

For example, the inspection revealed that your QCU released API lots to the U.S. without assuring that all required tests are performed. It is a basic responsibility of your QCU to ensure that all API lots produced meet specifications for quality and purity prior to being released. Your QCU also failed to detect that your COAs stated that OVI results conformed to specifications, although the test was not performed.

In addition to your failure to test (b)(4), USP, your QCU approved the release of (b)(4), USP batch # (b)(4) with no testing for OVI. This test is required under DMF (b)(4), submitted by your firm in 2005.

In your response, you stated that your former Head of Quality Control thought it was sufficient to test the organic volatile impurity in three (3) (b)(4) batches and then discontinue testing of future batches. We acknowledge that your firm has begun testing for organic volatile impurities.

Within fifteen (15) days of receipt of this letter please send us a list of all APIs (include lot numbers and dates) that were not tested. Also provide a copy of a complete investigation and retrospective review of all test results generated by your laboratory, and corrective actions to prevent recurrence.

Your response also indicates that you revised the procedure for releasing batches and trained the Quality Control and Quality Assurance personnel. Your response is inadequate in that it does not address the failure of your QCU to detect inaccurate reporting of laboratory results. It also lacks a description of any training program provided to prevent recurrence of the problem.

Please provide a comprehensive corrective action plan that describes your commitment, procedures, actions, and controls to ensure data integrity. This plan should include training to all managers, supervisors, and quality unit personnel in detecting data manipulation and questionable practices.

3. Failure to perform at least one identity test of each batch of incoming material.

For example, the starting material (b)(4) lot (b)(4), used for the production of (b)(4) USP, API lots (b)(4), was not tested for identity.

Please include a copy of your incoming raw material testing procedure and explain how your firm will assure all raw materials are tested prior to release for production in the future.

You are responsible for the accuracy and integrity of the data generated by your firm. A firm must maintain all raw data generated during each test, including graphs, charts, and spectra from laboratory instrumentation. These records should be properly identified to demonstrate that each released batch was tested and met release specifications. Appropriate record retention policies should also be in place. Our inspection reported that your firm has destroyed some old, but foundational records for your products. We recommend that your firm reconsider your record retention policy for application-related records. Should product quality or safety concerns arise in the future, the original records pertaining to batches listed in an application may be integral in providing reasonable assurances to the Agency regarding a product and integrity of data submitted to support it.

When destruction of documents is appropriate, you should follow a document destruction procedure that ensures documents are destroyed in a controlled manner. This would include, at a minimum, identification of the appropriate documents and retention timelines, documentation of what was destroyed, and the names and signatures of those who witnessed the destruction.

We recommend that you conduct a complete and extensive evaluation of your overall quality and manufacturing controls to ensure that all APIs manufactured at your facility meet the quality and purity characteristics they purport to possess. We highly recommend that you hire a third party auditor, with experience in detecting data integrity problems, who may assist you in evaluating your overall compliance with CGMP.

The deviations detailed in this letter are not intended to be an all-inclusive statement of deviations that exist at your facility. You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations. If you wish to continue to ship APIs to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.

Additionally, your firm is neither registered nor has it listed every API in commercial distribution in the United States with FDA, as required by 21 C.F.R. Â§ 207.40 and section 510(i) of the Act [21 U.S.C. Â§ 360(i)]. The FDA investigators discussed this issue with you during the inspection. Your response did not address this issue.

Qnexa Maker Vivus in Talks With FDA to Get Weight Loss Treatment to Market

Mary Williams wanted to lose weight and was ready to do the work.

“With a 5″ 5′ frame, 215 pounds was just too much,” Williams said. “I looked like the Nutty Professor.”

She tried dieting and exercising. She even tried phentermine, a drug approved for short-term weight loss, which helped her lose a measly four pounds.

Uninterested in bariatric surgery, Williams said she worried she had run out of options until a clinical trial at Duke University in Durham, N.C., opened a new door.

A daily dose of Qnexa — an experimental weight loss drug that combines phentermine with topiramate, a drug approved for epilepsy and migraine prevention — along with a diet and exercise helped Williams drop 38 pounds and six dress sizes in a year.

“When I would visit with friends and colleagues they would say, ‘Something has changed, you’ve lost weight.’ They were so impressed,” Williams said.

The average percent weight loss among 995 patients who received Qnexa in the phase 3 trial was 9.8 percent, compared to 1.2 percent among 994 patients who received a placebo. The trial findings were published April 9 in The Lancet.

But despite the promising results, the Food and Drug Administration rejected an application from drug maker Vivus to have Qnexa approved for the treatment of obesity, citing safety concerns. Qnexa was associated with a low but increased risk of psychiatric and cardiovascular adverse events. The FDA also wants Vivus to investigate the potential for Qnexa to cause birth defects.

“As clinicians and clinical researchers, we’d all consent that the FDA seem to have set a very different safety bar for drugs that treat weight loss compared to drugs that treat other conditions,” said Dr. Kishore Gadde, director of Duke’s obesity clinical trials program and lead author of the study.

Qnexa was one of three weight loss drugs nixed by the FDA in 2010.

“We need more options to treat obesity,” Gadde said. “In hypertension, you have about 40 to 50 drugs with different mechanisms. In obesity, when you try diet and exercise and it doesn’t work, you only have one drug before you jump to last resort, which is surgery.”

The single drug approved for the treatment of obesity — orlistat (Xenical or Alli) — acts by preventing the absorption of dietary fat. But it doesn’t quash hunger.

“People know they should cut down on calories. But if you only have orlistat, how do you deal with a patient who comes to you and says, ‘I know all this stuff but I cannot control my hunger?’ For that patient orlistat won’t work,” Gadde said.

Williams said Qnexa helped her feel less hungry and more energetic — a combination that helped her eat less and exercise more. After the trial ended, Williams started to gain some of the weight back.

“I do get a little lazy sometimes and do want to eat some of the goodies I see before me,” Williams said.

New Hope for Weight Loss Drug?

Vivus is in talks with the FDA to address any outstanding safety concerns, according to company president Peter Tam.

“We’re working diligently to resubmit the drug application,” Tam said. “We believe in this drug.”

Gadde and Tam said they think the FDA is being hard on weight loss drugs because of the number of Americans who would use them.

“Ultimately safety is the most important thing from FDA’s perspective,” Tam said. “For a drug like this that could be used by many Americans, safety has to be scrutinized.”

The FDA recently lowered the bar for lap band surgery, potentially expanding the eligibility from 13 million Americans to nearly 32 million — a move Tam hopes reflects some urgency within the FDA to do something about obesity.

“I think it’s all about risk-benefit assessment,” Tam said. “And [Qnexa] is a drug that has demonstrated a tremendous amount of benefit.”

Williams said she hopes the FDA will allow clinicians to weigh the risks and benefits of the drug for their patients.

“My doctor wants me to lose another 20 pounds,” Williams said. “It would be helpful for me if the FDA would pass it.”

Qnexa Yields Up to Nearly a 10% Weight Loss: Study

April 10, 2011 — The experimental weight loss drug Qnexa produces a loss of up to nearly 10% of excess weight, according to a study just published in the Lancet.

”The weight loss is impressive,” researcher Kishore M. Gadde, MD, director of the obesity clinical trials program at Duke University, tells WebMD.

The report published in The Lancet includes all the data that was already presented to the FDA last July by Vivus, the company developing the drug combination, Gadde says. However, he says, “this is the first time the data are presented in a peer-reviewed journal.”

In July, an FDA expert advisory panel recommended against approval of Qnexa.

Qnexa includes phentermine, a drug already approved for obesity, and topiramate, a drug already approved for epilepsy and to prevent migraine headaches.

Since the rejection by the FDA advisory panel, the company has been addressing the concerns, says Peter Tam, the president of Vivus, which funded the study.

One concern is the use of topiramate, linked with birth defects such as cleft lip and cleft palate, by women who may become pregnant. Vivus is in discussion with the FDA now about how to address those concerns, Tam says.

“Our goal is to resubmit the new drug applications by the end of 2011,” he says.

Qnexa: Study Details

For the study, researchers enrolled 2,487 participants, assigning them randomly to take either placebo pills or two different doses of the drug combination during the 56-week study.

In all, 2,448 patients were evaluated. This included 979 on placebo, 488 on the lower-dose regimen, and 981 on the higher dose. The lower dose included 7.5 milligrams of phentermine and 46 milligrams of topiramate. The higher dose was 15 milligrams of phentermine and 92 milligrams of topiramate.

To be eligible, patients had to have a body mass index of 27 to 45. No lower limit of BMI was in place for participants with diabetes. They also had to have two or more obesity-related conditions, such as high blood pressure or type 2 diabetes managed with lifestyle changes and/or the drug metformin.
Qnexa: Study Results

The average weight loss for those who completed the study was 28 pounds on the high dose, 22 on the low dose, and 4 pounds for those taking the placebo. The results meet criteria suggested by the FDA for weight loss products, Gadde tells WebMD.

Besides weight loss, Gadde tells WebMD, “this treatment led to significant improvement in excess weight-related diseases such as diabetes and high blood pressure and risk factors such as high cholesterol.”

Those on the drug had a greater reduction blood pressure and improvement in so-called good cholesterol, HDL cholesterol, than those on placebo. Those who had diabetes at the study start and took the drug were less likely to need an increase in diabetes drugs than those on placebo.

FDA will be ‘severely’ limited by shutdown

NEW YORK (CNNMoney) — A government shutdown will severely restrict food and drug inspections, an official with the Food and Drug Administration warned Thursday.

“We will be pretty severely limited. We’re hopeful that a resolution is reached before it comes to that,” the official said.

The FDA, which is an agency within the Department of Health and Human Services, consists of nine centers and offices and employs 13,000 workers.

The official did not say how many of those employees will be furloughed by a shutdown.

In the event of a shutdown, the agency’s Office of Regulatory Affairs, which oversees food inspections, won’t operate at full capacity but will have some inspectors on staff.

As a result, all FDA inspections of food processing facilities and drug manufacturing plants will be prioritized by risk. That means that inspections of high-risk plants which have a history of serious safety concerns will be prioritized ahead of routine plant inspections.

In the event of an emergency situation, such as a food borne illness outbreak, the FDA will able to call furloughed staff into work.
0:00 /02:27Impact of a government shutdown

The FDA’s current effort to monitor for radiation in food products coming from Japan – and for higher radiation levels in existing food products already in the market – will not be affected by staffing changes.

However, the FDA will not be able to conduct specific inspections of drug or medical device manufacturing facilities that are required when a manufacturer files for a new product application with the agency.

The FDA’s other centers, including the Center for Biologic Evaluation, Center for Veterinary Medicine, Center for Medical Devices and Radiological Health will also operate at reduced capacity.

Of the agency’s nine centers, only the Center for Tobacco Products, which employs 275 workers, will remain fully staffed in the event of a shutdown. That’s because it is funded by the tobacco industry.

Government Employees and Insider Trading: Surprisingly Rare

Last week, the SEC and DOJ both brought insider trading cases against a chemist employed by the U.S. Food and Drug Administration (FDA). The chemist, Cheng Yi Liang, allegedly used information he learned at the FDA about upcoming announcements of FDA drug approval decisions as the basis for insider trading that generated more than $3.6 million in illegal profits and avoided losses. The SEC claims Liang illegally traded in advance of at least 27 public announcements about FDA drug approval decisions involving 19 publicly traded companies.

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For example, a company called Clinical Data applied to the FDA for approval of a drug called Viibryd. Liang allegedly accessed a confidential FDA database that contained critical information about the FDA’s review of Clinical Data’s application, and relied on that information to purchase more than $700,000 worth of Clinical Data’s shares. The SEC alleges that after the FDA issued a press release approving Viibryd. Clinical Data’s stock price immediately rose by more than 67 percent, giving Liang a $380,000 profit.

Commenting on the case, Dan Hawke, Chief of the SEC’s Market Abuse Unit, stated that:

The insider trading laws apply to employees of the federal government just as they do to Wall Street traders, corporate insiders, or hedge fund executives. Many government agencies like the FDA routinely possess and generate confidential market-moving information. Federal employees who misappropriate such information to engage in insider trading risk exposing themselves to potential civil and criminal charges for violating the federal securities laws.

Commentators such as Professor Bainbridge have observed that this type of case against a government employee is extremely rare, and I believe that is correct. It is actually a bit surprising to me that such cases do not occur more often. After all, there are many federal and state employees that have access to market-moving information on a daily basis, such as:

* FDA employees (Duh);
* Patent and Trademark Office employees (access to nonpublic information about patent applications)
* SEC, DOJ and FBI employees (access to nonpublic information about ongoing investigations that may affect a company’s stock negatively when they become public);
* Federal and state judges, law clerks and administrators (access to nonpublic information about the outcome of cases. In fact, traders will sometimes have people sit in a courtroom during a trial so that they can race out and call them with the verdict in material litigation so that an early trade can be made);
* Federal Reserve employees (access to nonpublic information about interest rate changes);
* and so on….

Given that big firm lawyers, investment bankers, and Big 4 accountants who routinely possess inside information are commonly prosecuted and sued for insider trading, it is refreshing to realize that “government employee” cases are far more rare.

US FDA moves to protect data after trading charges

WASHINGTON, April 7 (Reuters) – The U.S. Food and Drug Administration is taking steps to strengthen protection of commercially sensitive information after an agency chemist was charged with insider trading, according to a memo provided to Reuters.

Food and Drug Administration Commissioner Margaret Hamburg said in the memo she had taken a “number of immediate steps to address potential vulnerabilities,” including a “new tracking system to better monitor employee access of data.”

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Hamburg also said she was creating a task force to review information technology security across the agency. The memo was sent to agency staff on Wednesday.

On March 29, an FDA chemist and his son were charged with using inside information about drug approvals to reap more than $3.6 million in profits.

Feds seize $6 million in medical products from wipe-maker

Federal officials on Wednesday seized more than $6 million in medical supplies distributed by a Wisconsin firm whose potentially contaminated drug products are blamed for serious infections and death. 483 is posted here.

U.S. Marshals, acting at the request of the federal Food and Drug Administration, seized a wide range of intimate care products manufactured and distributed by H&P Industries Inc. and the Triad Group of Hartland, Wis., FDA officials said.

They included povidone iodine and benzalkonium chloride antiseptic products, cough and cold medicines, nasal sprays, suppositories, medicated wipes, antifungal creams and hemorrhoidal wipes. Marshals also quarantined products that were still being processed as well as raw materials.

“We took this action to stop Triad from continuing to distribute products which may pose a risk to public health,” Dara Corrigan, FDA commissioner for regulatory affairs, said in a statement.

The move comes two days after H&P Industries officials confirmed that U.S. Marshals had entered the plant with seizure orders. In a letter to customers and vendors sent Tuesday and obtained by msnbc.com, firm officials said they wanted to avert such action.

“We had hoped and believed that our continued efforts to comply with corrective actions would allow us to continue to service the trade. That is not the case,” wrote Mary Aagesen, vice president for Triad Pharmaceuticals. “We are, of course, deeply disappointed in this outcome.”

FDA officials said the seizure follows the firm’s continued failure to comply with current good manufacturing practice or cGMP, regulations. The agency last week asked H&P Industries to voluntarily cease making and distributing drug products, but the firm did not heed the request.

FDA inspections at the plant led to three voluntarily recalls of Triad Group products since December 2010, including massive recalls of alcohol prep pads, povidone iodine prep pads and lubricating jelly because of problems with microbial contamination.

Investigators also found systemic problems that included issues with sterility and contamination and situations in which firm officials knew products were possibly tainted and sent them for public distribution anyway.

An inspection that concluded March 28 found problems with the firm’s air handling and water systems and “failure to take proper measures to ensure the quality of incoming components,” the FDA said.

Pad material, foil packaging are culprits

The investigation found that pad material and foil packaging were the source of contamination of alcohol prep wipes with the bacteria Bacillus cereus, which was later linked to serious infections caused by the same bacteria in wipes at a Colorado children’s hospital and in a Tennessee cardiac patient.

Parents of a 2-year-old Houston boy also sued the firm after the toddler died in December from an infection caused by Bacillus cereus they claim was transmitted by tainted wipes.

However, FDA officials knew about problems with contamination and sterilization at the Hartland plant dating back to 2009, inspection documents showed. They allowed H&P Industries officials to voluntarily correct problems because they believed there was no imminent public health hazard, according to Michael Rogers, the FDA’s acting director of the Office of Regional Operations.

The U.S. Marshals, the FDA and the U.S. Attorney for the Eastern District of Wisconsin cooperated in Wednesday’s investigation and seizure. The actual products are seized in place and quarantined at the site under court custody. The FDA’s investigation remains open, spokeswoman Shelly Burgess said Wednesday.

H&P Industries Inc. and Triad Group are firms owned and operated by brothers David Haertle and Eric Haertle of Wisconsin and their sister, Donna Petroff, of Antioch, Ill. The firms’ products are sold under the Triad Group label and under the private labels of many major drug stores and grocery stores, including Walgreens, CVS, Safeway and Walmart. They are also widely used in hospitals and clinics.

Precision Therapeutics Announces New Tumor Profiling Product to Augment Utility of ChemoFxÂ® and Further Personalize Cancer Treatment
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PITTSBURGH, April 7, 2011 /PRNewswire/ — Precision Therapeutics, Inc. announced that the launch of a new product line, BioSpeciFxÂ®, will help further the personalization of cancer treatments. BioSpeciFxÂ® is composed of carefully selected sets of well validated and clinically useful biomarker tests that identify critical molecular targets within a patient’s cell. By using the information generated by BioSpeciFxÂ® in combination with Precision’s sophisticated drug response marker ChemoFxÂ®, physicians may gain a more complete understanding of a patient’s tumor.

When combined, both products offer a complementary sum of information which will enable physicians to look at both the relevant molecular targets as well as the synergistic activity of drug combinations on the entire cell. BioSpeciFxÂ® provides proteomic and genomic information, while ChemoFxÂ® takes into account all of the functional characteristics of a tumor including those not captured by biomarker testing, providing both sensitivity and resistance information.

“The Comprehensive Tumor Profile developed by Precision presents the most complete offering available to cancer patients today, because it integrates both genomic and proteomic information with the functional profiling of ChemoFxÂ®,” says Sean McDonald, CEO of Precision Therapeutics. “We are very excited to provide physicians with a closer look at each patient’s tumor as we continue to develop products aimed at personalizing treatments for cancer patients.”

About Precision Therapeutics

For more information, visit www.precisiontherapeutics.com or www.chemofx.com.

SOURCE Precision Therapeutics
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Feds seize $6 million in medical products from wipe-maker

Family of dead toddler files lawsuit against Hartland’s Triad group

A Hartland company is facing multiple lawsuits, and a massive recall. The US Marshals, and the FDA appeared at the Triad Group to seize materials. 483 is posted here.

A once thriving company identified as the single largest manufacturer of alcohol prep pads, and swab sticks in the world is now virtually shutdown.

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H&P Industries of Hartland makes medical products under the name Triad group.

A lawsuit filed by the Texas parents of a two-year-old boy claims an alcohol wipe made by the company was contaminated with bacillus cereus, and used on the boy during medical care at a hospital.

Attorney Jim Perdue represents the family. He says, “After the FDA recall. The mother of this little boy who died realized that the reason for the recall was because of contamination with the exact same bacteria that killed her son…and that’s when the connection was made.”

Perdue says the family wants Triad group held accountable for the boy’s death. The FDA reportedly asked H&P Industries to stop production. A FDA inspection report outlines numerous problems at the plant.

The report said while investigating the bacillus cereus contamination of sterile, and non-sterile alcohol prep pads “the investigation identified the pad material and foil as potential sources.”

Plumbing issues were also sighted as a possible cause of contamination.

Perdue says since filing the suit on behalf of the two-year-old boy’s family, his firm is being contracted by five to ten people a day. They all say they’ve been affected by tainted alcohol pads and lubricating jelly.

There are reports of at least two other lawsuits against this company as well.

How Big Is Insider Trading Scandal for FDA?

Was greed the only motive for Cheng Yi Liang, the 57-year old chemist from Gaithersburg arrested last week along with his 25-year-old son Andrew in one of the Food & Drug Administrationâ€™s (FDA) biggest-ever scandals?

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May 19 – Warning Letter Update from Former FDA Chief Council Sheldon Bradshaw

April 12 – How to Prepare Yourself for 21 CFR Part 11 Audits
May 10 – Safeguarding Clinical Trial Activities: Prepare for GCP BIMO Inspections
May 11 â€“ 48 Hours Per Year to Quality Compliance – FDA Expectations of Sr. Management

To be sure, Liang, a mid-level career bureaucrat, must have enjoyed driving to work in Silver Spring in his snazzy new Infiniti sedan ($41K sticker price). He and his wife plunked down nearly $65,000 for a luxury Infiniti sedan and an Odyssey mini-van (bought at Hersonâ€™s Honda on Frederick Road) in just a couple of visits to car showrooms, according to court filings.

They also paid off credit card debt with the proceeds of the $3.6-million they allegedly gained illegally by trading on inside information of pending FDA drug approval decisions.

One thingâ€™s clear: the Liang case is a devastating blow to both the FDA and to investors who rely on a level playing field and honest and ethical dealings in the marketplace.

Liang used his position at the Center for Drug Evaluation Research in the Office of New Drug Quality Assessment to access inside information on approval of drugs, undermining the integrity of the entire process. He has worked at FDA since 1996 with an annual salary of close to $123,000 last year.

On perhaps his most shocking trade, Liang got advance word on a major FDA policy reversal that involved Vanda, a Rockville-based biotech outfit. In that case the FDA surprisingly approved Vandaâ€™s schizophrenia drug, called Fanupt, after first rejecting it.

Liang bought Vanda shares ahead of the announcement and watched them rocket from about one dollar to over $15 in just a matter of minutes. He sold at $9.40 per share and pocketed $l.04-million on that trade alone.

â€œWith investor suspicions as they are, and with growing discontentment with ethics in Washington by the population as a whole, the FDA wants anything but allegations of its personnel abusing their positions,â€ one stock market blogger noted in the affairâ€™s aftermath.

â€œLetâ€™s not fool ourselves,â€ they added. â€œNo one out there believes that Liang is the only one in that agency acting with the best interests of their own pockets at heartâ€”heâ€™s just the guy who got caught.â€

And beyond that: â€œIf a guy is willing to risk everything to make a few bucks from inside information, would he also be willing to alter information or put a folder at the bottom of a review pile in order to delay a decision that might benefit the new Porsche that he wants?â€

Something for FDA officials, stock analysts, investors and the general public to ponder.

Wipe-maker shuts doors after U.S. Marshals arrive on site

Wisconsin firm H&P Industries Inc., accused of making contaminated medical pads and wipes, has closed after U.S. Marshals arrived Monday with orders to seize products. 483 is posted here.

Contamination was detected in the firm’s antiseptic towlettes and in raw materials used to make over-the-counter fiber products often used as laxatives and to lower cholesterol, inspection reports found.

Contamination of povidone iodine prep wipes with different bacteria, Elizabethkingia meningoseptica, was detected on March 11 and led to an immediate recall of all lots of the product used to prep skin after scrapes and burns and before surgery, the report said.

In addition, inspectors found serious and systemic problems with the firm’s “high purity” water system.

“Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance,” inspectors wrote.

FDA officials found Triad BZK Towelettes, hygiene products made with the disinfectant Benzalkonium chloride, were contaminated with the bacteria Bacillus cereus, the same organism that led to a world-wide recall of the firm’s alcohol prep pads and wipes in early January.

Those wipes have been blamed in at least three lawsuits for serious infections and the death of a 2-year-old boy in Houston.

In the new FDA report, inspectors identified pad material and foil packaging used in the alcohol prep wipes as the potential cause of the contamination, with implications for other products.

“The impact to other products manufactured with the same or similar pad and foil was not assessed,” inspectors wrote.

In addition, investigators found that several batches of over-the-counter products failed to remain stable or failed to meet standards for active ingredients. They include hemorrhoidal suppositories and Triad PVP Swabsticks.

H&P Industries products are sold under the Triad Group label and under the private labels of many drugstores and grocery stores, including Walgreens, CVS and Walmart. They are also widely used in hospitals and clinics. For information about specific brands of recalled alcohol wipes, click here. For information about brands of recalled povidone iodine wipes, click here.

The firm also has recalled lubricating jelly and laxative suppositories.

Water supply problems

Problems with the plant’s water system include failing drains that could allow sewage to back up directly into the system and a “dead leg” in the water supply loop that could cause problems with heat sanitation, according to inspectors. Before March 2009, the firm failed to keep any records of sanitization of the water supply system, they added.

Last week, Michael C. Rogers, the FDA’s acting director for the Office of Regional Operations, said that the problems identified in the inspection report, the firm’s third in less than a year, prompted the agency to ask H&P Industries to stop manufacture or distribution of all drug products.

H&P Industries officials did not comply until the U.S. Marshals arrived on Monday.

Bennet, the Colorado senator, renewed his call for more oversight.

â€œTodayâ€™s events are a clear sign that the supply chain system for drugs and medical devices is broken,” Bennet said in a statement. “The last thing parents should have to worry about is a repeat of this sad situation that put thousands of families at risk, including a Colorado child who developed a life-threatening infection. As FDA reauthorization approaches in Congress, I will continue to fight for stronger oversight for industry, robust quality standards for manufacturers, and greater accountability from the FDA.â€

N.J. courts Bayer HealthCare to keep pharmaceuticals operation

Gov. Christie said that Pennsylvania was “eating our lunch” when it came to providing incentives to attract and keep companies.

It would appear that lunch is being served in the Garden State now.

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Bayer HealthCare Pharmaceuticals on Monday said it planned to consolidate its North Jersey locations in Wayne, Morristown, and Montville into one new complex in New Jersey and move its Tarrytown, N.Y., operation there as well.

Best-known for its Bayer aspirin, Bayer HealthCare said it employed a total of about 2,500 people at those four locations.

Just don’t ask Bayer where the new operation will wind up, because the company says it has not picked a specific location – only that several sites near its existing facilities are being considered.

Helping Bayer executives to choose New Jersey was the offer of public subsidies totaling about $35 million. In February, the pharmaceutical company was awarded a $14.1 million grant from the New Jersey Economic Development Authority’s Business Retention and Relocation Assistance Grant. In January, the state approved a grant of up to $21 million through its Business Employment Incentive Program.

Will it be taxpayer money well-spent? After all, the pharmaceutical industry has been restructuring for years now, cutting sales forces and eliminating overhead. When Merck & Co. Inc. bought Schering-Plough Corp. and Pfizer Inc. bought Wyeth, both in 2009, the resulting cuts fell hard on the New Jersey operations.

According to the Quarterly Census of Employment and Wages collected by the federal Bureau of Labor Statistics, employment in New Jersey’s pharmaceutical and medicine manufacturing sector peaked at 42,256

in 2007. It dropped to 37,957 in 2008 and 33,993 in 2009.

Just last November, Bayer AG said it planned to cut its global workforce by about 2,000, to 108,700 by 2012. About 4,500 positions, including 1,700 in Germany, were to be eliminated, while about 2,500 jobs would be created, specifically in emerging markets.

Last time I checked, neither New Jersey nor the United States was an emerging market. Bayer Corp., based in Pittsburgh, said annual sales in the United States “remained steady” at $9.4 billion in 2010. In all, Bayer Corp. had 15,100 employees at year’s end.

In a statement, Bayer HealthCare Pharmaceuticals Inc. president and CEO Mark Trudeau said the company was “very excited”

about the prospect for a new facility that would house employees from various divisions “under one roof.”

As soon as late 2011, some of those Bayer HealthCare employees are expected to begin moving into a new complex, presumably in North Jersey. Plans call for the relocation to be completed by the end of 2013.

The Christie administration said Bayer’s decision to stay in New Jersey “will help keep us the premier state in the nation for the pharmaceutical industry.”

Still, pharmaceuticals remain such a terrifically profitable business, it’s hard to swallow that New Jersey needed to offer so much to retain Bayer.

Read more: http://www.philly.com/philly/business/columnists/119232279.html#ixzz1Ie3Zi4wW
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Footstar Completes Acquisition of CPEX Pharmaceuticals, Inc.
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Olshan Grundman Frome Rosenzweig & Wolosky LLP served as legal advisor to Footstar.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS

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Chairman and Chief Executive Officer of Footstar, Inc.
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Technology Collaboration Between New England Biolabs and Sequenom Delivers First Product for Epigenetics
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IPSWICH, Mass. and SAN DIEGO, April 5, 2011 /PRNewswire/ — New England Biolabs, Inc. (NEB) and Sequenom, Inc. (NASDAQ: SQNM) jointly announce that they have signed a licensing and co-marketing agreement to commercialize research tools for epigenetics. This agreement is the result of a research collaboration between the two companies that has culminated in the development of the EpiMarkâ„¢ Methylated DNA Enrichment Kit from NEB.

(Logo: http://photos.prnewswire.com/prnh/20090921/NE79207LOGO-b )

The EpiMark Methylated DNA Enrichment Kit utilizes the innovative proprietary technology and intellectual property, methyl-CpG-immunoprecipitation (MCIp), acquired by Sequenom through an assignment of intellectual property rights from the University of Regensburg, Germany. The MCIp technology is based on the work of Prof. Michael Rehli at the Department of Hematology and Oncology. It is used to advance discovery and analysis of differentially methylated regions in biological samples, such as methylation differences between fetal and maternal chromosomes that can enable non-invasive prenatal diagnostics.

The EpiMark Methylated DNA Enrichment Kit incorporates the methyl-CpG binding domain of human MBD2, fused to the Fc tail of human IgG1. When coupled to magnetic beads, this antibody-like protein enables purification of methylated CpG DNA with superior sensitivity, accuracy and speed. NEB has enabled and optimized large-scale, high purity manufacturing of the protein and developed a user-friendly kit for the research community.

NEB will also be Sequenom’s first choice supplier if the technology should be utilized for prenatal diagnostic purposes in the future. Sequenom has retained all rights for diagnostic uses.

“Collaborations have always played an essential role in the development of innovative research tools at New England Biolabs,” states Dr. Salvatore Russello, Associate Director of Business Development at NEB. “This collaboration has been of great value to NEB and has facilitated the development of a novel tool to drive the discovery of epigenetic markers, an exciting new area of basic and applied research.”

Dr. Karsten Schmidt, VP of Business Development at Sequenom commented, “We are pleased that through a productive collaborative effort with NEB, we are able to make available to the research community a research reagent that should have broad applicability in the detection and analysis of differential DNA methylation.”

The EpiMark Methylated DNA Enrichment Kit is part of a suite of EpiMark validated products for epigenetics, which was launched by New England Biolabs at the AACR 2011 Annual Meeting (Orlando, FL; April 2â€“6, 2011). For more information, visit www.epimark.com.

About NEB

Established in the mid 1970’s, New England Biolabs, Inc. is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, cellular analysis, epigenetics and RNA analysis. Additionally, NEB is focused on strengthening alliances that enable new technologies to reach key market sectors. New England Biolabs is a privately held company, headquartered in Ipswich, MA and has extensive worldwide distribution through a network of exclusive distributors, agents and five subsidiaries located in Canada, China, Germany, Japan and the UK. For more information about New England Biolabs visit www.neb.com.

About Sequenom

Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.

SEQUENOM(R) is a trademark of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.

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Avandia Lawsuit Settlement News: ‘No News is Bad News,’ Says Plaintiffs
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First Quarter Comes and Goes Without Final Settlement Figures

NEW YORK, April 5, 2011 /PRNewswire/ — The latest news on the much publicized Avandia Settlement’s is: there is no news. After a Bloomberg report made public last summer that many of the Avandia suits were coming to a settlement range of approximately $86,000.00 per suit, no new news has come into the market. This has left many suffering Avandia plaintiffs with more confusion -and concern- when they will actually get their settlement money.

This has led to many Avandia Plaintiffs to seek lawsuit funding in order to receive some cash to pay bills today, prior to getting their actual settlements. Once industry that tracks the Avandia litigation is the “legal funding industry,” where in March one funding company, lawsuitssettlementfunding.com (Legal-Bay LLC), announced a substantial rise in Avandia lawsuit cash advances.

Dave Kole, CEO of Lawsuitssettlementfunding.com, spoke about the recent developments, “most of our clients tell us the same thing, they are frustrated with the process. They are confused because there has been no news in the marketplace about how much they will receive, or worse, when they will actually receive their money. Many of them were notified that they would have answers by the end of the first quarter, but now that we are in April, they simply can’t wait any longer. I only expect more and more Avandia Plaintiffs to seek lawsuit funding each day this drags on.”

Industry experts believe that the Avandia litigation is getting more complex based on the few articles released of late.

In January GlaxoSmithKline agreed to take a total of a $3.4bil charge on the expected Avandia settlement. This is an increase from the $2.4bil charge announced last summer. The increase raises more questions as to the magnitude of the total settlement; and if Avandia will surpass Vioxx as the largest Pharmaceutical settlement in U.S. History.

Also, in February the Louisiana AG Office sued GlaxoSmithKline for civil fraud involving Avandia. The increase in more litigation involving Avandia â€“and the subsequent delays- is now only hurting the people most affected by the drug. And that is the Avandia long suffering plaintiffs and their families waiting for their settlement money.

Contact and Source:
CNJ Enterprises LLC
Chris Janish, CEO
862-485-7655
Email: cnjenterprisesllc@gmail.com

SOURCE CNJ Enterprises LLC
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Optimer Announces that the U.S. Food and Drug Administration’s Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificidâ„¢ for Treatment of Patients with Clostridium difficile infection (CDI)
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Optimer to host conference call for investors on April 6 at 8:00 a.m. Eastern Time

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SAN DIEGO, April 5, 2011 /PRNewswire/ — Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) recommended that the FDA approve Optimer’s investigational antibiotic DIFICIDâ„¢ (fidaxomicin) for the treatment of patients with Clostridium difficile infection (CDI), a bacterial infection in the lining of the gut that can cause severe diarrhea, colitis and in some cases death. In a unanimous 13-0 decision, the AIDAC found that the clinical evidence submitted by Optimer demonstrated the safety and effectiveness of DIFICID for the treatment of CDI.

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“We view the vote of the FDA’s panel of expert advisors, with diverse backgrounds ranging from infectious disease to biostatistics, as a strong endorsement for approving DIFICID for the treatment of CDI. We are encouraged that the advisory committee recognizes the urgent need for new treatment options for CDI and the seriousness of the increasing incidence of these infections,” said Pedro Lichtinger, President and CEO of Optimer. “We are proud to be one step closer to providing patients, healthcare providers and physicians with a new treatment option for CDI, a serious and debilitating disease that can impact every aspect of a patient’s life.”

The FDA is not bound by the committee’s guidance but takes its advice into consideration. Optimer submitted its New Drug Application (NDA) for DIFICID on November 30, 2010. The FDA accepted the DIFICID NDA filing and granted a six-month Priority Review in January 2011, assigning a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011.

“In Phase 3 clinical studies, DIFICID was proven to be as effective as vancomycin in clinical cure, and was superior to vancomycin in global cure, defined as cure without a recurrence after 4 weeks of therapy. The advisory committee referred to the global cure outcome as 30-day resolution, which we believe is indicative of DIFICID’s benefit in reducing recurrences,” said Sherwood Gorbach, M.D., Optimer’s Chief Medical Officer. “While the advisory committee vote was split on how best to describe the recurrence benefit, the committee members overwhelmingly recognized that DIFICID at 30 days was superior to vancomycin. We appreciated the committee’s discussion and look forward to working with the FDA as it considers our DIFICID NDA.”

The AIDAC based its decision in part on the review of clinical evidence from the two largest, comparative Phase 3 clinical trials ever conducted against vancomycin in CDI. These multi-center, randomized, double-blind trials enrolled a total of 1,164 adults with confirmed CDI, who received either DIFICID (200 mg q12h) or vancomycin (125 mg q6h), the only FDA-approved product for the treatment of CDI. The objective of both studies was to show that a 10-day course of DIFICID was at least as efficacious (non-inferior) and safe as a 10-day course of vancomycin for the treatment of CDI. In both studies, DIFICID demonstrated a statistically significant reduction in the rate of recurrence compared with patients treated with vancomycin, reducing CDI recurrences by 47 percent, and was statistically superior to vancomycin in global cure rate (clinical cure without disease recurrence within four weeks). In addition, DIFICID met the primary endpoint of non-inferiority of clinical cure (defined as patients requiring no further CDI therapy two days after completion of study medication) compared to vancomycin.

DIFICID was safe and well tolerated in both studies, showing a similar incidence of treatment-related adverse events when compared to vancomycin.

Scheduled Conference Call

Optimer will host a conference call tomorrow at 8:00 a.m. Eastern Time (5:00 a.m. Pacific 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 DIFICIDâ„¢ (Fidaxomicin)

DIFICIDâ„¢ (fidaxomicin) is a new antibiotic with a novel mechanism of action, which inhibits the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile. The narrow-spectrum profile of DIFICID eradicates C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, have been shown to disrupt the gut flora. DIFICID facilitates the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence rates. In two Phase 3 trials for the treatment of CDI, DIFICID was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. DIFICID also demonstrated statistically significant reduction in recurrences and an increase in global cure rate, defined as cure without recurrence. Importantly, DIFICID reduced the risk of recurrence by 47% compared to vancomycin. 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.

About Clostridium difficile Infection (CDI)

Clostridium difficile infection (CDI), 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 rise in incidence of CDI, along with high rates of both treatment failures and recurrences with current therapies has resulted in greater awareness and concern about CDI among medical professionals and public health officials. Advancing age is one of the most significant risk factors for CDI and with the 65-plus population growing every year in the US, the incidence of CDI has the potential to increase in hospitals and long-term care facilities. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.

About Optimer

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, DIFICIDâ„¢ (fidaxomicin) and Pruvelâ„¢ (prulifloxacin). DIFICID is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company’s request for six-month Priority Review of DIFICID, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for DIFICID. 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.

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