Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Ibexx who wrote (6848)	1/28/1999 3:43:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

Pfizer Tells FDA Panel Its Drug Can Treat Atrial Fibrillation Bloomberg News January 28, 1999, 2:02 p.m. ET Bethesda, Maryland, Jan. 28 (Bloomberg) -- Pfizer Inc. representatives told members of a U.S. government panel that the company's Tikosyn drug can fight a potentially deadly heart irregularity known as atrial fibrillation. The backing of the U.S. Food and Drug Administration advisory panel is crucial for Pfizer, the fourth largest U.S. drugmaker, in its bid to win U.S. approval of Tikosyn. The panel later will answer a series of detailed questions about the drug's potential safety risks and whether it's better or worse than older drugs used to treat the condition. Pfizer representatives told the panel that the drug doesn't pose any more risks than currently available therapies, such as the generic drug quinidine. Tikosyn, also known as dofetilide, can help patients retain normal heart rhythms, improving their quality of life, they said. ''Our current therapeutic options are limited and all of them are associated with measurable risk,'' said Jeremy Ruskin, a researcher from Massachusetts General Hospital. Tikosyn ''would provide a useful addition.'' Still, Tikosyn probably won't be a blockbuster if it's approved and therefore won't have a major effect on Pfizer, which reported revenue of $3.87 billion in the fourth quarter, they said. Analysts estimate Tikosyn could have peak annual sales of between $300 million and $750 million if approved. More important for Pfizer are sales of drugs such as its Viagra anti-impotence pill and marketing agreements such as the one it has with Monsanto Co. for the new painkiller Celebrex, analysts said. ''Commercially, and from an earnings standpoint, the co- marketing of Celebrex is much more important for Pfizer,'' said Richard Stover, an analyst with Arnhold & S. Bleichroeder. Shares of New York-based Pfizer rose 1 3/4 to 123 11/16 in midafternoon trading. Earlier, Pfizer announced plans to hold a vote in April on splitting its stock 3-for-1. Limited Options Pfizer will be helped in its bid to win approval of Tikosyn by the fact that there are limited options available for the estimated 2.2 million Americans with atrial fibrillation, analysts said. The company could face questions on safety, however, because studies have suggested the drug can in some cases actually cause a dangerous type of irregular heart rhythm. During an open public hearing, Larry Sasich of the watchdog group Public Citizen urged the panel to recommend against approval of the drug. Potential Risks Sasich said his group is worried about the potential risks of Tikosyn, especially given the history of anti-arrhythmic heart drugs which have the potential to actually harm patients if not used correctly. ''We do have serious concerns,'' he said. Pfizer representatives showed the panel results of two major studies involving about 1,100 atrial fibrillation patients with varying analyses. Under the best case scenario, Tikosyn brought about 30 percent of patients back into a normal heart rhythm compared to only about 1 percent of patients given a placebo. This ''conversion'' is one use the panel will consider today. The other use the panel will consider is ''maintenance,'' or reducing the recurrence of the irregular rhythms. In its best- case analyses, Pfizer found Tikosyn was able to keep between 58 and 66 percent of patients free of atrial fibrillation or so- called atrial flutter for a year. That's compared to between 21 percent and 25 percent of patients given a placebo. While Pfizer is considered a marketing powerhouse and has a host of profitable drugs, it also has had two significant setbacks at the FDA in recent years. Last year, the company failed to win an expected approval for its Zeldox schizophrenia drug. And in 1996, Pfizer stopped development of its tenidap drug for rheumatoid arthritis after an FDA advisory panel rejected it. If it wins final FDA approval for Tikosyn, Pfizer will face competition from Cincinnati-based Procter & Gamble Co., the largest U.S. marker of household products. The company, which is trying to increase its presence in the pharmaceutical market, filed for FDA approval of its azimilide drug in December. P&G shares rose 1 9/16 to 87 7/8 in recent trading. --Kristin Jensen in Bethesda, Maryland with reporting from