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Allergan, the maker of Botox and Latisse sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

The impetus for the lawsuit is an FDA requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment. According to an Allergan spokesperson, "Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment." In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

Allergan estimates that 20% of Botox usage is off-label for unapproved indications. Because of this, the company believes that it is important to “proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique to ensure that physicians are equipped to treat patients as safely and successfully as possible. And, “without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution." 

It sounds to me like the lawsuit is more about increasing the annual sales of Botox for a growing number of unapproved indications rather than ensuring patient safety. These types of lawsuits have becoming increasingly popular because of previous legal precedent that extends an individual’s right to freedom of speech to corporations and other entities. However, more importantly, if Allergan is successful, it could signal the end of the regulations and ban on off label promotion of prescription drugs and devices. Is eliminating a few wrinkles from aging baby boomers (like me) worth all the trouble?

Until next time...

Good Luck and Good Job Hunting (hmm...maybe if I look younger I might be able to find a job?)

 

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As many of you may know, Ranbaxy was involved in a bitter patent dispute with Pfizer over Lipitor, Pfizer’s blockbuster multibillion, dollar anti LDL-cholesterol drug. Ranbaxy was challenging the validity of Pfizer’s intellectual property estate for Lipitor which would have extended patent protection for the drug until 2013 or longer. The patent dispute began after Ranbaxy filled an ANDA with the US Food and Drug Administration to sell generic Lipitor after uncontested Lipitor patents expire in early 2010.

Conventional wisdom suggested that Pfizer would ultimately lose the patent dispute and that Ranbaxy would be able to immediately flood the market with a much cheaper generic version of Lipitor. This would have an enormous negative impact on Pfizer’s financial stability and its future (Lipitor had $12.8 billion in sales in 2007). Nevertheless, untilDaiicho-Sankyo announced its intention to acquire Ranbaxy last week, Pfizer was willing to gamble and run the risk of losing the lawsuit. Apparently, Ranbaxy impending sale was enough of an impetus for Pfizer to settle the patent dispute which has grown increasingly acrimonious over the past year or so.

According to agreement (which needs to be approved by the US Federal Trade Commission), Pfizer was able to get Ranbaxy  to agree to delay the release of generic Lipitor until November 2011 — up to 20 months later than many analysts had been expecting (some insiders believed that generic Lipitor could reach the market as early as March 2010). Further, as part of the agreement, Pfizer will allow Ranbaxy to sell its version of Lipitor in Australia, Canada, Belgium, Germany, Italy, the Netherlands and Sweden two to four months before Liptor’s patents expire. This is likely the sweet part of the deal for Ranbaxy because all of the above mentioned markets are top sellers for anti-cholesterol drugs. Finally, because Ranbaxy was the first to file an ANDA for generic Lipitor with the FDA, it will get 6 months of market exclusivity guaranteed (in the Hatch Waxman Act) to a generic manufacturer that is first to file for generic production of a brand name drug nearing patent expiry.   However, after quickly perusing the terms of the deal, I think that it more closely resembles an authorized generics deal rather than a “true” competitive generics launch.

Currently, Lipitor costs about $2.50 to $3 a day. Analysts predict that Ranbaxy can sell its generic Lipitor for about 75 cents to $1 a day, or as low as 10 cents a day at some discount pharmacies. The potential drastic price reduction coupled with Daiichi-Sankyo’s intention to purchase Ranbaxy (which would have provided Ranbaxy with more money underwrite and press on with IP lawsuit, it what I believe forced Pfizer’s hand to act as quickly as it did to settle the suit. The deal, if approved, allows Pfizer to dodge a near fatal financial bullet and will provide it with a potentially lucrative revenue stream from it authorized generics deal that it struck with Ranbaxy. 

Nevertheless, given the financial stakes associated with the Lipitor franchise, it may make more sense for Pfizer to purchase Ranbaxy rather than enter into the pending deal. Also, a Ranbaxy purchase would allow Pfizer to enter the biologics and biotechnology fields—something that Pfizer executives have been talking about publicly to insure the company’s future. Like most other pharmaceutical generics manufacturers, Ranbaxy has active research programs on biosimilar and other biotechnology products. If I was driving the boat at Pfizer I would offer Ranbaxy a lucrative counteroffer to block its sale to Daiichi-Sankyo. I don’t know—the deal just makes sense to me. That said, not many recruiters have been calling me about CEO jobs lately!!!!!!

Until next time…

Good Luck and Good Job Hunting!!!!

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A federal judge ruled that Amgen Inc. must defend itself against charges that it misled investors about safety concerns with its flagship anemia drug, Aranesp.

A US district court judge dismissed charges against five of nine Amgen officers and directors but left plaintiffs 30 days to amend their complaint in order to include those defendants. The investors, led by Connecticut Retirement Plans and Trust Funds, assert that positive statements made by company officials regarding the safety of Amgen's two anemia drugs, Aranesp and Epogen, were knowingly at odds with clinical studies that had raised concerns.

The plaintiffs assert, according to court filings, that they unknowingly purchased artificially inflated shares, between April 2004 and May 2007. In one instance, during its fourth-quarter 2006 conference call, Amgen announced results of a clinical trial that tested Aranesp in 939 patients with anemia from cancer. The Food and Drug Administration, according to court filings, described the study as "demonstrat(ing) significantly shorter survival rate in cancer patients receiving (anemia drugs) as compared with those (sic) receiving transfusion support."

Describing the results of the study during the conference call, Roger Perlmutter, a defendant and executive vice president of research and development, said, "We did not see a statistically significant adverse affect of Aranesp on overall mortality in this patient population, and so we conclude that the risk/benefit ratio for Aranesp in these extremely ill patients with anemia secondary to malignancy is, at best, neutral and perhaps negative."

Sounds misleading to me! It is unfortunate that companies compromise their scientific integrity and corporate reputation simply to boost their stock price in the short term. I think companies are slowly learning that if they are dishonest or disingenuous with the American public that the public will soon lose confidence in them and their products. This, in turn, will lead to a decrease in sales and ironically a reduction in company stock price. As the old adage goes “Honesty is always the best policy!”

Until next time….

Good luck and Good Job Hunting!!!!!!!!!!!!

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It goes without saying that Amgen has had a run of bad luck over the past six months. But, just when you thought things couldn’t get much worse, two former Amgen sales representatives are suing the company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of its blockbuster drug Enbrel.

The ex-employees are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece. One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after he received a negative performance review.

A lawyer representing the ex- reps alleges the marketing scheme to increase sales of the drug started in 2005 or sooner, after new drugs competing with Enbrel came on the market. "Amgen stepped up their marketing practices to get all these people who were not indicated for Enbrel" to start taking the drug, she said.

Enbrel which is approved to treat rheumatoid arthritis and moderate to severe cases of psoriasis generated $3.0 billion in sale for Amgen last year. Enbrel treatment can cost as much as $20,000-$50,000 per patient per year depending upon disease severity. 

Stay tuned for the next installment of the ongoing Amgen saga!

Until next time….

Good Luck and Good Job Hunting (not in A Thousand Oaks)!!!

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I have to tip my hat to Merck. I thought it was silly that company executives decided not to settle all of the litigation surrounding the Vioxx debacle. Instead, the company decided to challenge all of the individual Vioxx lawsuits filed against it. That said, the New York Times reported today that the New Jersey Supreme Court rejected a bid by Vioxx plaintiff lawyers to bring a Vioxx class action suit against Merc which is based in Whitehouse, NJ. The state's highest court reversed two lower court rulings and decided that a nationwide Vioxx class action suit was not appropriate. The suit had been brought by a union health plan on behalf of all insurance plans that paid for Vioxx prescriptions, or about 80 percent of all Vioxx sold.

This was huge victory for Merck because New Jersey consumer fraud law allows for triple damages and the class action suit could have cost the company $15 to $18 billion. Further, the company’s strategy of fighting Vioxx lawsuit individually has also paid off. Of the cases that have reached verdicts, Merck has won 9 and lost 5. A new trial was ordered in one case and two ended in mistrials. To the objective observer, Merck is winning–possibly paving the way for the company to reintroduce Vioxx to the market with new restrictions for use.

After the ruling was made public, shares of Merck rose more than 2 percent to $50.47 on Thursday. For those of you who do not follow the stock market, Merck’s share price plummeted to the mid-twenties after the Vioxx situation developed close to two years ago. I guess that is why Mr. Clark and not I is the CEO of Merck.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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