Chain Drug Review - Dr Reddy’s sued over Norvasc. (Digest).(by Pfizer, alleging patent infringement)(Brief Article)
NEW YORK — The withdrawal of Pfizer’s cholesterol drug torcetrapib from clinical trials was one of the biggest news stories to hit the medical field last year.
It was bad news for physicians and consumers, but also for the drug giant, which was banking on the drug replacing Lipitor, its top-selling blockbuster drug, when its patent expires in 2010. Immediately after the withdrawal announcement in early December, Pfizer shares plummeted by 15 percent to $23.65. The drug maker since has announced that it doesn’t expect to see any revenue growth until 2009.
In the wake of this, two other drug manufacturers have declared their plans to jump into the hole that will now be left when Lipitor’s patent expires.
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Merck’s president and chief executive officer, Richard Clark, said last month that it has a drug in Phase II trials that’s in the same class as torcetrapib. MK-0859 is a cholesterol ester transfer protein inhibitor, which raises HDL cholesterol and lowers LDL cholesterol. Merck declined to say when an NDA for this drug would be submitted to the FDA.
Roche also is developing a CETP inhibitor, R1658, already in Phase II clinical trials, and is being jointly developed by Roche and Japan Tobacco.
“R1658 is from a different chemical series than torcetrapib,” said Terence Hurley, a Roche spokesman. Now in Phase II clinical trials, it has not shown any adverse cardiovascular changes or increases in blood pressure as reported with torcetrapib.
Furthermore, he said, the adverse cardiovascular effects associated with torcetrapib have not been reported with any of the other CETP inhibitors currently in development. “Therefore, at this time, we believe the cardiovascular side effect associated with torcetrapib is most likely a compound-specific finding and not a class related effect.”
Pfizer was forced to withdraw torcetrapib due to the number of deaths that occurred during the clinical trials, and the company is facing a number of challenges.
Jason Napodano is a senior pharmaceutical analyst with Zacks Independent Research and at presstime, had a sell rating on Pfizer. “The loss of the main pipeline product for the company is not good news,” he said. He had a sell rating, he said, because the company also is facing a wave of patent expirations. These include Lipitor, Norvasc–its second best seller-Zoloft, Zytrec and Zithromax.
“I think a lot of people were holding onto their stock because they thought things would be better when torcetrapib came to the market, but in 2010 [when Lipitor expires], things are just likely to get worse.”
Before the withdrawal of torcetrapib, Pfizer intended it and Lipitor to be taken in conjunction–torcetrapib to raise HDL (good cholesterol) and Lipitor to lower LDL (bad cholesterol). The drug company would probably have eventually combined the two into one drug, Napodano pointed out.
With global sales in 2005 of $12.9 billion, Lipitor constitutes about 25 percent of Pfizer’s topline, he said, and when Lipitor loses its patent, it will lose 80 percent to 90 percent of sales in the first year. If torcetrapib had been successful, the company would have pushed for as many patients as possible to be transferred to it from Lipitor. “This is as bad as it is because [Pfizer doesn’t] just lose torcetrapib, but torcetrapib and the future extension of Lipitor,” Napodano said.
The withdrawal of torcetrapib will also mean it will be more difficult for a generic drug to come to market to replace Lipitor, predicted Dr. Anna Obolesnksy, pharma project manager for market research company visiongain in the United Kingdom. This is because they will have to prove that they don’t have the risks that the brand name &mg had which caused it to be pulled.
In a glimmer of hope, Pfizer has been working to promote a new combination therapy called Caduet, which contains both Lipitor and Norvasc, a treatment for high blood pressure. Pfizer researchers said they believe this could be a new comprehensive approach to battling cardiovascular disease.
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COPYRIGHT 2008 Gale, Cengage Learning