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

To: BigKNY3 who wrote (6914)	2/4/1999 7:11:00 AM
From: BigKNY3	Respond to of 9523

FDA recommends approval of Pfizer's Tikosyn February 4, 1999 Marketletter via NewsEdge Corporation : The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted seven to two to recommend approval of Pfizer's Tikosyn (dofetilide) to treat atrial fibrillation. However, the panel said that doctors need to use the drug very carefully, and that further studies on its potential to interact with other drugs should be conducted. In clinical trials, 60%-70% of patients treated with Tikosyn maintained normal heart rhythms for a year, said Jeremy Ruskin of Massachusetts General Hospital, who presented evidence on behalf of Pfizer. Only 25% of patients treated with a placebo reported the same results, he said. The drug does not pose any more risk than current treatments, such as quinidine, it was noted. The results of two major studies with about 1,100 patients showed that under the best case scenario, Tikosyn brought about 30% of patients back into normal heart rhythm versus 1% of patients given a placebo, Pfizer said. The only possible side effect, according to Pfizer, was inducement of another potentially life-threatening heart rhythm disturbance that showed up in a small percentage of patients during trials. Risks would be minimized if doctors monitored new Tikosyn patients in the hospital and followed dose instructions, the company added. Pfizer told panel members that the drug could improve the quality of life for people with chronic atrial fibrillation, prolong the time between recurrences of atrial fibrillation and produce no significant side effects. At an open meeting, Larry Sasich of Public Citizen's Health Research Group spoke out against approval, given the history of anti-arrhythmics which can potentially harm patients if not used correctly. Two currently available drugs were probably safer than dofetilide, he added. The drug could generate $200-$500 million a year for the company, according to Alex Zisson of Hambrecht and Quist. Other analysts feel that Tikosyn could have peak annual sales of $300-$750 million, if approved. However, none feel that the drug will be a blockbuster, with a major effect on the company's bottom line, and Richard Stover of Arnhold and Bleichroeder noted that commercially, and from an earnings standpoint, the co-marketing of Celebrex with Monsanto is much more important for Pfizer. While noting that good treatments for atrial fibrillation are needed, Ken Nover of AG Edwards said that approval would show a positive trend for Pfizer at the FDA. Others noted that Pfizer will have to overcome the side effect history of older anti-arrhythmia drugs, and pointed to the evidence in the company's studies that Tikosyn could cause a different type of dangerous heart rhythm. If the drug is approved, it will likely face competition from Procter & Gamble's Stedicor (azimilide) for which a New Drug Application was filed last December.