Merck to expand packaging center in Wilson NC
Merck announced Tuesday that it will spend $15 million renovating and expanding its facility in Wilson NC.
May 17 – How to Survive PREDICT
The capital projects, which include overhauling existing manufacturing space and adding a cold storage facility for vaccine packaging, will not increase the company’s workforce at the site. Merck employs about 400 people at its 225-acre packaging center in Wilson, which opened in 1983.
Most of the Merck pharmaceutical products now packaged in Wilson are done so at room temperature.
Vaccines, which are a growing part of Merck’s business, require expansive cold storage space.
Merck has a vaccine plant in Durham that is poised to become the largest live-vaccine production facility in the world.
The rapidly growing lab, which makes chicken pox vaccine, employs about 850 and could expand to 1,000 workers at full production.
By 2013 Merck expects to be making at the Durham facility at least four vaccines for shingles, measles, mumps and rubella.
Read more here: http://www.newsobserver.com/2012/05/02/2038854/merck-to-expand-packaging-center.html#storylink=cpy
Category : News
Pfizer Coughs Up $450M to Brigham Young U. Over Celebrex
To put an end to what could have been an embarrassing and potentially costly episode, Pfizer has agreed to pay $450 million to Brigham Young University and endow a chair in the name of Daniel Simmons, a professor who claimed the drugmaker wrongfully cheated him out of money and credit for research that led to the discovery and commercialization of the best-selling Celebrex painkiller (see page 13 here). A trial had been scheduled to begin later this month.
Simmons maintained that he discovered the Cox-2 enzyme in 1991 that evolved into Celebrex and that the university signed a research agreement with Monsanto, which later became part of the big drugmaker. However, Simmons and BYU charged the deal was “fraudulently” ended without compensation, a former Monsanto chief scientific officer took credit for the discovery and that Simmons’ work was used as a roadmap for developing the painkiller (here is the lawsuit).
The trial was likely to generate some heat, because the proceedings may have pulled back the curtain on the dealings between the pharmaceutical industry and academia, which are increasing their ties as drugmakers turn to universities for help in replenishing their pipelines. For instance, BYU and Simmons charged that Monsanto engaged in such shenanigans as secretly testing a compound using confidential Simmons’ research, which they alleged was a breach of their agreement.
There was also the possibility of a financial impact on Pfizer, since BYU and Simmons sought sizeable damages. Celebrex has generated billions of dollars in sales over the years for Pfizer which was prompted, in part, to purchase Pharmacia in order to obtain the rights to the drug (Pharmacia merged with Monsanto, which had acquired GD Searle). Last year, Celebrex revenue exceeded $2.5 billion. And the pill notched $634 million in first quarter revenue this year. In other words, Pfizer coughed up sales that were generated in just 70 days in exchange for ending the lawsuit. Of course, this does not include legals fees racked up over several years.
But what took so long? Courtroom horseplay. In late 2009, a judge slapped Pfizer with more than $852,000 in attorney fees and other costs after finding the drugmaker stalled. In successfully arguing for the fine, BYU had pointed to repeated delays in providing it with evidence in the case and charged that some evidence had been destroyed. The judge chided Pfizer for “abuses and “repeated failures” in producing documents and ruled that “Pfizer has interfered with the judicial process
Category : News
Four killed, 17 injured in blast in pharma unit’s reactor
Four persons were killed and 17 others injured in a blast in a leading pharmaceutical company’s manufacturing unit at Basauli village near Lalru town in Punjab, Inida.
“The blast took place in the chemical reactor of the pharma unit which makes formulations for the antibiotics.
Seventeen persons were injured in the incident,” SSP, Mohali, G P S Bhullar said.
Two of those who died hailed from Uttar Pradesh, Lalru Police in-charge Gurbant Singh said, adding, the condition of three persons was serious.
Stating the blast took place in the morning shift, Gurbant said, a massive fire engulfed the factory premises when reactions were taking place in the reactors.
Preliminary investigations revealed that static charge resulted in the fire that led to the incident.
There was an explosion in one of the reactors, which caught fire and another adjoining reactor also exploded causing casualties and injuries.
A total of 34 people were said to be inside the unit at the time of the mishap, out of which 13 were safe.
Bhullar, who rushed to the site along with senior civil administration officials, said the injured were taken to various hospitals in the area.
Fire tenders rushed from Mohali and Derabassi to the site brought the flames under control after after three hours.
The deceased were identified as Nirankar Singh, shift-in-charge, Patra Khan and Sushil Kumar, both workers and office boy Bunty.
The incident took place at the bulk drug, antibiotic intermediate manufacturing plant of the company involved in making Active Pharmaceutical Ingredients (APIs) for bulk drugs used in formulations, mostly antibiotics.
Gurbant said that police had registered a case under Section 304 (negligence) of the IPC against the owners and management of the pharma facility.
Meanwhile, the company will give Rs 5 lakh compensation to the next of kin of the deceased and employment to one of the family members. The company has also announced Rs 1 lakh compensation to the injured.
Category : News
Astrazenca Former CEO Gets The Ultimate Golden Parachute
Now, that he is retiring after a spell of disappointments on the job, David Brennan may yet have reason to feel cheery. An unconfirmed report in The Sunday Times over the weekend suggests the outgoing ceo – who officially leaves on June 1 – will receive a $65 million exit package that includes an annual pension of approximately $1 million a year (back story).
One could argue this is overly generous, given the setbacks that occurred on his watch. These include continual struggles to replenish the product pipeline and the failure of the $15 billion acquisition of MedImmune five years ago to yield any substantive results. Nonetheless, Brennan saw his 2011 compensation rise 11 percent (see this).
However, an AstraZeneca spokesman notes that final details have not been determined and the package will reflect a long tenure that began decades ago in sales. “The exact terms of David Brennan’s package on retirement have yet to be agreed by the board, which we’ll disclose in due course. The figures used in media reports are entirely speculative at this stage,” he writes us. “The pension fund David has built up reflects a 36-year career with the company at increasingly senior positions.”
Whatever the final numbers, the package may become the subject of debate, if only because ceo compensation is such a hot-button issue these days, especially when companies have generated disappointments. Another example has been Bill Weldon, who is about to step down as ceo at Johnson & Johnson, but will remain chairman for an unspecified period of time.
The embattled Weldon will receive $143.5 million in retirement (read here), although his tenure has been pockmarked by repeated quality control lapses that led to embarrassing manufacturing gaffes, product recalls and a consent decree, which contributed to declining sales and a loss of standing among consumers.
Category : News
Abbott Submits Petition to FDA to Not Approve Biosimilar
In a move that is sure to raise debate about the path forward for biosimilars, Abbott Laboratories has filed a citizen’s petition with the FDA in which the drugmaker asks the agency not to approve any biosimilar for its Humira treatment for rheumatoid arthritis. On what grounds? Abbott argues that the FDA would have no choice but to use trade secrets submitted to the agency when approval for Humira was first sought.
“Under well-established Supreme Court jurisprudence, FDA’s use of the trade secrets in (Abbott’s) Biologics License Applications to support approval of competitor products would frustrate (its) investment-backed expectation regarding their property and would constitute a taking under the Fifth Amendment to the US Constitution that requires just compensation,” Abbott writes in its 30-page petition, which was filed on April 2.
The drugmaker goes on to note that at least three companies have begun pre-clinical or clinical testing of a Humira biosimilar. And so, Abbott writes the FDA should not “accept for filing, file, approve or discuss with any company, or otherwise taking any action indicating that the agency will consider any application or any investigational new drug application for a biosimlar” that cites the Humira BLA.
Not surprisingly, the logic is extended to refer to any drugmaker or biotech that submitted a BLA for product approval prior to the enactment of the Biologic Price Competition and Innovation Act of 2009, which is incorporated into the Affordable Care Act that was signed into law in March 2010. Abbott stresses, by the way, that previous court rulings found that data submitted to the FDA constitutes trade secrets (here is the citizen’s petition).
Abbott appears to have set the stage for this argument more than a year ago. Last August, The Food and Drug Law Journal ran an essay about the Constitutional protection of trade secrets under the Affordable Care Act that was written by Richard Epstein, who is a New York University School of Law professor and a senior lecturer at the University of Chicago. Abbott supported his research, although Epstein wrote that the conclusions were his own. Here is his summary…
“The Biologics Price Competition and Innovation Act of 2009 introduced an elaborate statutory bargain under which FDA may approve biosimilars that are ‘highly similar’ to a ‘reference product’ that has been approved by FDA through a full biologics license application. In exchange for this partial taking of its trade secrets, the reference product sponsor receives a 12-year exclusivity period and the opportunity for pre-market patent litigation. This statutory bargain is protected by strong constitutional constraints. In particular, the doctrine of unconstitutional conditions prevents Congress from simply announcing that FDA may take the pioneer’s trade secrets,” Epstein wrote (see here).
“Moreover, the statutory quid pro quo serves as the just compensation for the partial taking. Accordingly, FDA must use caution in implementing the Biosimilars Act so as to preserve this delicate balance. For example, biosimilar applicants cannot bypass the mandatory patent exchange process, and FDA should create procedures ensuring that the taking of the pioneer’s trade secrets does not exceed what is envisioned by the Act. The bargain also raises serious constitutional concerns if it is applied retroactively to pre-enactment products. In any event, FDA may not approve biosimilars of pre-enactment products given the lack of clear Congressional intent for a retroactive effect,” Epstein concludes.
Category : News
How the FDA Stifles New Cures, Part III: A Proposal for Reform
On Tuesday, the Manhattan Institute released a study I authored, entitled “Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials.” The paper discusses how outdated FDA policies are making drug development too expensive and too risky. In this excerpt, I describe the most promising avenue for FDA reform: a “conditional approval” process that would allow limited marketing of drugs after mid-stage clinical trials.
The French economist Frédéric Bastiat wrote in 1850 of “that which is seen, and that which is not seen.” Truer words could not be penned of the pharmaceuticals industry, whose great tragedy stems from that which is not seen: promising drugs that are not being prescribed because of the expense and risk of developing them.
When promising treatments are kept off the market, the patients who fail to benefit go unseen. This is especially true with common conditions such as obesity, where effective drugs would be used by millions of Americans. What is “seen,” by contrast, are concerns about drugs that were approved by the agency and later turned out to pose problems. When this happens, FDA officials are often hauled before Congress and asked to defend their decisions. At the agency, expeditious approval of innovative drugs is risky; excessive caution is not.
Hence, while it is important to encourage the FDA to streamline its regulatory process, it is even more important to consider ways that Congress can create the legal incentives for the FDA to approve more pharmaceuticals and permit more companies to enter the market.
Specifically, three aspects of the agency’s current approach are out of date and create significant costs and delays in the development of useful drugs.
First, the system is oriented toward acute diseases, like contagious infections, in which symptoms appear rapidly and the effect of medication is also relatively quick. Such diseases were the most prevalent menace to public health when the federal government began regulating drugs in 1906. Today, however, the greatest dangers to long-term public health are chronic non-communicable diseases such as heart ailments, diabetes, stroke, and cancer. These conditions can persist for decades. That makes it more difficult to measure the true effects of a medication in the time scale of even the most wide-ranging of clinical trials.
Second, the current approval system for a drug is “all or nothing”: if a medication is approved, it is judged effective for all patients at all times, and it may be marketed by all legal means. If, on the other hand, the drug is judged not effective enough to justify approval, it is withheld altogether from the public. Yet most victims of chronic illnesses have more than one medical problem, and their symptoms vary individually over time. Medication to treat heart disease, then, may be useful in some instances, for some people, in a way that is hard to capture by an either/or evaluation method.
Third, as we have documented in this paper, the current system is extremely costly to implement. This is due not only to its very high standard of proof for effectiveness but also to the FDA’s broad powers to determine what constitutes a satisfactory trial. Even after Phase I, II, and III trials are complete, the agency can, for example, demand answers to new questions or impose new criteria for success. As a result, a great deal of uncertainty hangs over even the most promising trial results.
More Balanced, More Effective: Expanding the Role of Conditional Drug Approvals
There is one step that government and industry can take to reduce dramatically the risks and cost of drug development: abandon the current black-or-white approval process in favor of an incremental, conditional one. In such a process, drugs could be provisionally approved after promising early-stage data, with the FDA retaining the option to revoke that approval later on, should unexpected data come to light.
A “conditional approval’’ approach would grant limited marketing authorization to new drugs after successful Phase II trials. Under conditional approval, patients most in need can benefit from a new drug, and companies can generate a modest amount of revenue that can help fund Phase III trials for full approval. A conditional approval for betrixaban, for example, would allow Portola to generate incremental revenues that could fund its Phase III program, dramatically reducing the risk that the company would lose everything if betrixaban failed to show a benefit in larger trials.
As we’ve mentioned, a conditional approval model already exists, in the FDA’s accelerated approval process. The accelerated approval process was instituted in 1992, after a decade of advocacy by HIV/AIDS patients. Because it often takes years for drugs to demonstrate definitive clinical benefit in traditional Phase III trials, the FDA created the process to approve a drug after Phase II studies if those studies show that it is “reasonably likely to predict a real clinical benefit.” For example, a cancer drug that causes tumors to shrink is “reasonably likely” to extend life. However, drugs can cause tumor shrinkage in a matter of months, whereas it may take years for a drug to definitively prove that it extends life relative to the old standard of care.
Unfortunately, the FDA severely restricts the accelerated approval process to serious, life-threatening diseases. Doctors and biopharmaceutical developers have long sought a broad expansion of the accelerated approval process. For example, Susan Desmond-Hellman, chancellor of the University of California at San Francisco, recently proposed a system in which companies could gain conditional approval in exchange for agreeing to a more restrictive marketing authorization. She specifically cited the experience of Arena’s Lorqess in her remarks:
You could have an approval process that started out with a low-level approval. You don’t get a sales force, you can’t promote that drug and you can’t put TV ads on it. But you could sell it. Then you increase your confidence. “We haven’t seen any heart attacks after five years—looking good. The ten pounds [of weight loss] is really holding up and in fact, some of the patients as they stay on the drug longer, lost 15 pounds. OK, maybe you can have a sales force. Still no ads on TV.” Then you gain more confidence; it gets to be eight years.
Is there a system where we could, as we increase our confidence in safety and advocacy, allow for broader distribution and more promotion? Not a yes or a no answer? I think that could really change two things. One is, the odds in the business model would be more stacked in favor of investing in difficult things like obesity, type 2 diabetes, [and] high blood pressure, which were at risk for no innovations.
An alternative approach would be to give companies the regular amount of leeway in the way they market conditionally approved drugs but require that any promotion include information that the drug had been only conditionally approved. The drug’s sponsors would face strict, contractual requirements requiring them to conduct well-controlled Phase III trials even as they marketed their pharmaceutical. The FDA could revoke a drug’s approval status if those trials were not satisfactory or, if in use, the drugs ended up proving to have an unfavorable risk-benefit profile.
How Reform Would Change Development Incentives for the Better
It’s worth considering how a conditional approval process could transform the economics of pharmaceutical innovation. Today, GLP-1 analogues achieve nearly $2 billion in annual sales per drug, and analysts project similar sales for approved antiobesity drugs. Using those figures, we modeled the impact of an FDA policy that offered conditional approval to such pharmaceuticals, restricting their use to the 10 percent of obese or diabetic patients whose conditions were most serious and most resistant to existing therapies. Selling to only 10 percent of a drug’s $2 billion market would yield a $200 million opportunity—not too far from the average cost of Phase III trials for antiobesity ($254 million) and GLP-1 ($187 million) drugs. In other words, a conditional approval approach would let companies largely recoup the costs of later Phase III trials.
Allowing these companies to gain revenues for their medicines in these severely obese or diabetic patients would allow them to fund Phase III trials with dramatically lower financial risk, while still demonstrating that their drugs were sufficiently safe and effective. (As we’ve mentioned, the costs of Phase I and II trials are far lower: we estimate that obesity companies spent an average of $24 million per drug on Phase I and II trials, and developers of GLP-1 analogues have spent an average of $15 million.) Companies could engage in research for new medicines. They would still be risking tens of millions of dollars in R&D spending. But they would not be risking hundreds of millions and their corporate lives.
Worth the Effort: The Impact of Reform on Public Health and Economic Growth
Reforms to address the cost of Phase III trials have no obvious constituency in industry or government. The FDA is averse to all risk, even when there are countervailing benefits. And large pharmaceutical companies benefit when smaller players are forced to partner with the giants in order to survive the Phase III process. The general public, though, has a strong interest in repairing a system that stifles medical innovation.
The social and economic benefits of pharmaceutical innovation are plain in health statistics. For example, between 1999 and 2005, the introduction of new heart drugs correlated with a 45 percent drop in coronary-artery disease patients dying of heart attacks in hospitals. Similarly, between 1995 and 1997, as new anti-HIV drugs became available, the annual death rate from HIV declined by 63 percent. The United States continues to lead the world in this important area, directly employing 655,000 Americans in the drug-development sector and supporting the employment of millions more.
Yet the industry faces significant danger. As described above, the costs and risks of new drug development are skyrocketing, making it more difficult to attract capital to start new biotech companies and raising questions about the ability of even large companies to sustain high levels of investment in drug research and development.
The biopharmaceuticals industry is a significant contributor to American R&D spending. From 2000 to 2007, drug companies spent $105,428 in R&D per employee, far more than any other American manufacturing industry. (Far behind, in second place, was the communications equipment industry, at $62,995 per employee.) For its contributions to the nation’s economic health, to say nothing of its literal health, this industry should be encouraged to continue innovating. Unfortunately, current regulatory practices have the opposite effect.
Conclusion
Our research has established that Phase III trials are, by far, the biggest expense, and the biggest risk, of new drug development. In fact, we have found that Phase III trials are even more expensive than is commonly thought. That expense distorts the drug-development system so that it does not efficiently and rationally allocate time and money to find new medications. Regulators block useful drugs from reaching patients. Researchers are discouraged from attempting to serve the most numerous populations of patients. And investors face the prospect of spending vast sums for nothing.
Hence, it is of paramount importance to mitigate the binary, yes-or-no nature of drug development. This black-or-white regulatory process discourages investment in new medicines. In contrast, if the United States adopted a flexible, conditional approval approach that allowed sponsors to recoup some of their R&D costs before, or during, large-scale clinical trials, we could dramatically lower the risk and cost of drug development. We believe that the consequence would be an explosion of private investment in medical research and development, providing a substantial boost to one of the largest sectors of our economy.
Congress, therefore, should create clear standards for conditional approvals and also give the FDA more flexibility to develop new regulatory tools that are better adapted to the rapid advances in basic science and that have the potential to accelerate patient access to safer and more effective therapies.
Along these lines, Senator Kay Hagan (D-N.C.) has introduced a bill titled “Transforming the Regulatory Environment to Accelerate Access to Treatments,” or TREAT. A draft version of this bill, encouragingly, sought to facilitate the “progressive and exceptional approval” of new drugs “to accelerate patient access to new medical treatments.” These include treatments that address a previously untreated disease; those aimed at patients who are failing existing therapies; and those that show unusual clinical promise.
Unfortunately, the FDA and other stakeholders opposed this measure, and it was taken out of the bill before its introduction. Instead, the current version of the proposed TREAT Act includes a modest expansion of the existing accelerated approval process—far short of what is needed to address the problem described in this paper.
The true policy solution is already clear, thanks to two decades of experience with the existing accelerated approval process. Today, the FDA’s incentives impel it to avoid the “seen” error of approving new medicines that later pose concern. By contrast, it has little incentive to avoid the “unseen” error of blocking new medicines that could ease the suffering of millions of people. Only Congress can correct this distorted incentive system, by granting the FDA the authority it needs to change.
Further Reading
(In case you missed it, Part I of this series described how the costs of drug development are rising overall. Part II discussed why Phase III trials comprise 90 percent of clinical trial costs.)
Follow Avik on Twitter at @aviksaroy.
UPDATE: Ron Bailey of Reason and Paul Howard of Medical Progress Today have additional useful thoughts on the “conditional approval” idea. Here’s Ron:
Roy is not alone in his advocacy for conditional approval. In a February 14 Wall Street Journal op-ed, former FDA Commissioner Andrew von Eschenbach argued that “after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.” Just such a system could be incubating in the FDA’s new Sentinel computer tracking system that looks for side effects in drugs once they’ve gone onto the market. Last year, some researchers asserted that the smoking cessation drug Chantix increased the risk of heart attacks. Based on its Sentinel analysis of the relevant databases, the FDA concluded this year that Chantix does not boost the risk of heart attacks.
Given the rapid evolution of bioinformatics, it might one day be possible to roll out most new pharmaceuticals after the equivalent of Phase II trials. Since medical and prescribing records will be online, drug researchers could compare people who choose take conditionally approved new drugs with a population that does not, matched for various confounders such as age, other medical conditions, behaviors, etc. Essentially, the health care system itself might become a gigantic Phase III trial for new treatments.
Delaying access to new drugs kills people. As Competitive Enterprise Institute general counsel Sam Kazman has observed [PDF], “Whenever FDA announces its approval of a major new drug or device, the question that needs to be asked is: If this drug will start saving lives tomorrow, then how many people died yesterday waiting for the agency to act?” Roy’s proposal is a good first step toward moving the drug approval process into the 21st century.
Paul makes some interesting points about the decline in products being advanced into Phase III:
By Phase III, companies should have a pretty good idea of what they’re looking at, in terms of the safety and efficacy profile of their candidates. But the number of projects failing in that late stage more than doubled over the last decade, according to CMR, from 26 to 55.
CMR also reported a decline in the number of new products entering Phase III trials, a 55% decline from 2007-2010. (Phase I and Phase II starts were down as well.) Oncology appears to be one of the few areas of where companies are increasing their investments.
Meanwhile, TheStreet.com’s Adam Feuerstein thinks I’m being too tough on the FDA:
Not everyone is in total agreement with Roy’s assessment, however. The Street’s Adam Feuerstein poked at Roy’s analysis in a Twitter posting, asking, “How much blame should be parsed to incompetent drug companies?”
Feuerstein further commented that “spiraling costs, delays and unproductive R&D” are unlikely factors to be pinned on FDA.
Category : News
New ED drug may work in 15 minutes
Look out Viagra – there’s a new erectile dysfunction drug in town.
It’s called Stendra (aka Avanafil) and it’s newly approved by the Food and Drug Administration, making it the first ED drug to come out in almost 10 years.
Although Stendra has not been tested against what is known as the “Little Blue Pill,” drug makers say that – for some men – it may work faster.
“If things are heated up, theoretically you can get improved function earlier, within 15 minutes, with this drug,” said Dr. Irwin Goldstein, director of sexual medicine at Alvarado Hospital in San Diego, and co-author of a recent study about Stendra in the Journal of Sexual Medicine.
“You can argue this is the first potential on-demand drug.”
The “on-demand” drug could end up in high demand for men with ED who do not respond to drugs like Viagra, Cialis and Levitra.
Goldstein, who has authored more than 300 studies in the field of sexual dysfunction, said that early data suggests Stendra may perform faster than other ED drugs, but that must be proven in a larger, real-world population.
Goldstein and his team studied 1,267 men who took a 50, 100 or 200 milligram dose of Stendra – or placebo – about 30 minutes before engaging in sexual activity.
The men filled out questionnaires indicating, for example, how long it took before they engaged in sexual intercourse or became aroused.
“For some men it works in 15 minutes, for some men it took longer,” said Goldstein.
To be clear, no one is suggesting that men should drop Viagra – or any other of the popular ED drugs– for Stendra.
“There is no drug that is the best,” said Dr. Laurence Levine, a professor in the department of Urology at Rush University Medical Center in Chicago, who was not a part of the Stendra study. “Each patient’s own chemistry may make one drug better than another. There are certain advantages and disadvantages to all of these drugs.”
Stendra is another option in a field of effective and safe drugs, said Levine.
A small minority of patients experienced side effects after taking Stendra, according to the study, including headaches, flushing, nasal congestion and back pain.
And overall, patients taking any ED drug – all of which work similarly – should be aware of rare side effects like sudden loss of vision or hearing, according to the FDA.
Category : News
FDA Cites 10 Companies For DMAA Products Sold Without Evidence Of Safety
Cracking down on dietary supplements containing a substance popularly known as DMAA, the U.S. Food and Drug Administration on Friday issued warning letters to 10 distributors and manufacturers, citing the companies for marketing the products without submitting evidence of their safety to the agency.
DMAA is dimethylamylamine, aka 1,3-dimethylamylamine, geranium extract, or methylhexanamine. It is frequently described as a so-called natural stimulant, the FDA said.
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law [i.e., the Dietary Supplement Health and Education Act of 1994] to provide evidence of the safety of their products. They haven’t done that, and that makes the products adulterated,” said Daniel Fabricant, director of the FDA’s Dietary Supplement Program.
The FDA warning letters advised the companies the agency is unaware of either evidence or history of use that indicates DMAA is safe.
The warning letters noted that DMAA is known to constrict blood vessels, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath to tightening in the chest to heart attack.
The FDA has received 42 adverse-event reports on products containing DMAA. Although these reports do not establish that DMAA was the cause of the events, some of these incidents were associated with cardiac disorders, nervous-system disorders, psychiatric disorders, and death.
Signed by Michael W. Roosevelt, acting director of the Office of Compliance in the Center for Food Safety and Applied Nutrition at the FDA, the warning letters were sent to the following companies (whose affected products appear in parentheses):
– Exclusive Supplements (Biorhythm SSIN Juice).
– Fahrenheit Nutrition (Lean Efx).
– Gaspari Nutrition (Spirodex).
– iSatori Global Technologies LLC (PWR).
– Muscle Warfare Inc. (Napalm).
– MuscleMeds Performance Technologies (Code Red).
– Nutrex Research (Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers).
– SEI Pharmaceuticals (MethylHex 4,2).
– SNI LLC (Nitric Blast).
– USP Labs LLC (Oxy Elite Pro, Jack3D).
Category : News
Targacept says it will eliminate 65 jobs
Drugmaker Targacept Inc. said Wednesday that it plans to eliminate 65 jobs, cutting its work force by almost half, as it looks for ways to save money after an experimental depression drug failed.
Targacept had 142 employees as of Feb. 29 and said it expects to save $12.9 million per year from the job cuts. The company said it is eliminating some jobs because it is focusing its resources of specific drug candidates in clinical and preclinical testing. It expects to report $2.4 million in restructuring and severance costs in 2012.
The company also said Chief Medical Officer Geoffrey Dunbar, who also is in charge of clinical development and regulatory affairs, will retire at the end of May. Targacept said Dunbar has been with the company for 11 years.
In March, Targacept and its partner AstraZeneca PLC ended development of a depression drug candidate called TC-5214 because the drug failed in clinical studies. In April it said a drug it was testing to treat asthma failed to meet one of its two goals in a clinical trial. Targacept had previously reported that the drug did not work as a treatment for diabetes.
Targacept said it will update its guidance when it reports its first-quarter results on May 3. The company said it has $220 million in cash and investments in marketable securities.
Category : News
Astrazeneca CEO Departs Amid Disappointing Quarter
Poor David Brennan. At the annual meeting of PhRMA in Boston only two weeks ago, he was stoutly defending his strategy as AstraZeneca ceo. Now comes the news that he is departing. As of June 1, the struggling drugmaker will be temporarily led by Simon Lowth, chief financial officer.
Ironically, just a month ago, Brennan received an 11 percent pay raise, despite concerns about pipeline problems and a looming patent cliff and cost-cutting that will include the elimination of 7,000 jobs (see here).
In March, AstraZeneca lost a bid to prevent generic competition to its multi-billion-dollar-selling antipsychotic drug, Seroquel. To help bolster its pipeline, the drugmaker earlier this week agreed to purchase Ardea Biosciences for $1.26 billion. It’s the biggest deal made under Brennan’s tutelage since buying Medimmune in 2007 for about $15.2 billion.
Not a lot has come out of the Medimmune acquisition, however, and AstraZeneca has since suffered disappointing clinical results for potential treatments for severe depression and ovarian cancer.
Brennan had a few stock words to say about his departure during a phone call with reporters about disappointing first-quarter financial results. “The time for reflection on what has been a long and rewarding career with AstraZeneca will have to wait until I hand over responsibilities,” he says. “For now, my attention remains and will continue to remain 100 percent focused on delivering our strategy. But I do want to say that I am proud of what we have achieved in my time as chief executive.”
Category : News
