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

To: Ibexx who wrote (6856)	1/28/1999 5:57:00 PM
From: Anthony Wong	Respond to of 9523

Bloomberg: Pfizer Wins FDA Panel Recommendation for Tikosyn Heart Drug Bloomberg News January 28, 1999, 5:11 p.m. ET Pfizer Wins FDA Panel Recommendation for Tikosyn Heart Drug Bethesda, Maryland, Jan. 28 (Bloomberg) -- Pfizer Inc., the fourth largest U.S. drugmaker, won the backing of a U.S. Food and Drug Administration advisory panel for its Tikosyn drug to treat potentially deadly irregular heart rhythms. The FDA panel voted to recommend approval of the drug for patients with problems including atrial fibrillation, a hard-to- treat condition in which contractions in the upper chambers of the heart cause irregular, rapid heart beats in the lower chambers. Panel members said they thought the drug could help some patients even though it does have risks. ''The data are going in the right direction,'' said Peter Kowey, a panel member and professor from Jefferson Medical College. He and other panel members are still discussing exactly which types of patients should receive the drug . If the FDA follows the advice of the panel, as it typically does, Pfizer could see peak annual sales of $300 million to $750 million for the drug, analysts said. Shares of the New York-based company, which reported $3.87 billion in revenue in the fourth quarter, rose 5 1/16 to close at 127. Earlier, Pfizer announced plans to hold a vote in April on splitting its stock 3-for-1. The drug would enhance Pfizer's stable of top-selling heart drugs, analysts said. More important for Pfizer are sales of drugs such as its anti-impotence pill Viagra 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. Recommendation Expected Before the meeting, analysts said they expected the FDA advisory panel would back Tikosyn, also known as dofetilide, because there are few good options for patients with the potentially deadly irregular heart rhythms known as arrhythmias. Studies supporting the drug have been adequate, even if they haven't been overwhelmingly positive, analysts said. ''We really need good treatments for atrial fibrillation,'' said Kenneth Nover, an analyst with A.G. Edwards. Approval would also ''show a positive trend'' for Pfizer at the FDA, he added. While Pfizer is considered a marketing powerhouse and has a host of profitable drugs, it has also had two significant setbacks at the FDA in recent years. Last year, the company failed to win an expected FDA 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. Few Good Treatments Pfizer representatives today told the panel that Tikosyn could both help bring patients back into a normal heart rhythm and also prolong the time between recurrences of atrial fibrillation. There are currently few good treatment options for the condition, which affects an estimated 2.2 million Americans, they said. To get doctors to prescribe Tikosyn, Pfizer will have to overcome the history of older anti-arrhythmia drugs, which in some cases have been shown to actually harm patients. Also, there was some evidence in Pfizer's own studies that Tikosyn could cause a different type of dangerous heart rhythms. Pfizer said the problem could be reduced by careful monitoring and control of the drug's dosing when it's first administered. If it wins final approval for Tikosyn, Pfizer is likely to have some competition from Cincinnati-based Procter & Gamble Co., the largest U.S. maker 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 1/2 to close at 87 13/16. --Kristin Jensen in Bethesda, Maryland with reporting from More News: PFE