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

To: Anthony Wong who wrote (8220)	10/6/1999 6:16:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 9523

Pfizer Wins U.S. FDA Approval for Tikosyn Heart Drug (Update1) 10/4/99 2:32:00 PM Source: Bloomberg News (Adds background in paragraphs 2, 4, 8-10.) Washington, Oct. 4 (Bloomberg) -- Pfizer Inc., the No. 2 U.S. drugmaker, won U.S. Food and Drug Administration clearance to sell Tikosyn, a new drug to treat potentially deadly irregular heart rhythms. The FDA approved the drug therapy for atrial fibrillation, a hard-to-treat condition in which contractions in the upper chambers of the heart cause irregular, rapid heartbeats in the lower chambers. There are currently few approved treatments for the condition, which increases the risk of stroke and even death. ''Approval comes at a good time for Pfizer. For a company with a reputation for good R&D they have had some problems lately,'' said Alex Zisson, an analyst with Hambrecht & Quist, who estimates the drug will have peak sales between $200 million and $500 million. Pfizer has suffered recent setbacks as concerns over the safety of its approved Trovan antibiotic -- once expected to become a blockbuster drug -- spurred the FDA to restrict use of the drug to the worst cases of infection or to hospitalized patients. And in August, Pfizer dropped development of its experimental drug Alond for use in treating the nerve damage caused by diabetes, after tests showed the drug didn't have a significant effect. Pfizer shares rose 5/16 to close at 37 5/8. Approval of Tikosyn was expected because Pfizer said in March that the drug had been deemed ''approvable'' by the FDA, meaning the agency planned to clear the Tikosyn after ironing out details like manufacturing issues. Tikosyn is likely to compete with drugs including Schering AG's Betapace, which is approved for use in treating a different type of irregular heart rhythm. Betapace received the recommendation of an FDA panel in April for use in controlling the atrial form of heart flutter. Tikosyn could also face competition from an experimental drug made by Procter & Gamble Co., called azimilide, which is under review at the FDA for use in treating atrial fibrillation. Atrial fibrillation, or an erratic heartbeat, affects an estimated 2.2 million Americans, Pfizer said, and can cause dizziness and weakness. It also occurs in about 30 percent of the 2.5 million Americans with congestive heart failure and can worsen symptoms of that disease and make movement uncomfortable. The FDA said the drug should only be used in patients with fibrillation so severe that there are marked symptoms, because Tikosyn can also trigger arrhythmias in the heart's lower chambers, or ventricles. The drug is approved for use in converting patients from an irregular rhythm to a regular heartbeat, as well as to prolong the interval between bouts of arrhythmia. -- Rachel Dodes in Washington (202) 624-1820 with Kristin Reed in Washington (202) 624-1858 and Brian Reid in Washington (202) 624- 1930 /mfr/tab