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

To: Joe S Pack who wrote (7679)	5/13/1999 7:24:00 PM
From: Little Gorilla	Read Replies (1) \| Respond to of 9523

FOCUS-Novartis gets approvable letter for Exelon Thursday May 13, 5:54 pm Eastern Time EAST HANOVER, N.J., May 13 (Reuters) - The U.S. unit of Swiss pharmaceuticals company Novartis AG on Thursday said it has received an approvable letter from U.S. regulators for Exelon to treat mild to moderate Alzheimer's disease. Novartis Pharmaceuticals Corp. said it expects final clearance for the drug by the end of the year. An approvable letter is usually the final step before a product receives U.S. Food and Drug Administration clearance for marketing in the U.S. If approved, Exelon would compete with Aricept, made by Japan's Eisai Co. Ltd. and distributed by Pfizer Inc.(PFE - news), and with Cognex, developed by Warner-Lambert Co. (WLA - news). They are the only two Alzheimer's drugs on the U.S. market. ''Novartis will work very closely with the FDA to discuss various aspects of the approvable letter including labeling and final timelines. We expect approval by the end of this year,'' the company said in a statement. Exelon is expected to reach peak sales of $550 million worldwide in 2003, with about 60 percent of those sales in the United States, according to drug analyst Terrence Norchi, M.D., of Sanford C. Bernstein. ''I suspect Exelon will do reasonably well,'' said Dr. Norchi. ''It's an important drug but not a blockbuster for Novartis because it is such a huge company.'' The analyst added that there are several drugs to treat Alzheimer's Disease in company pipelines that will start to hit the market in 2001 and 2003. ''You can't assume which one will be superior because they have not been tested against the other. But you can assume that the new ones coming out will be the same or incrementally better,'' he said. Aricept and Exelon are considered the second generation of drugs to treat the incurable brain disease that affects up to about four million people in the U.S. alone. The two drugs are reversible inhibitors of acetylcholinesterase, an enzyme that breaks down the neurotransmitter acetylcholine. Acetylcholine is associated with cognitive functions such as memory, learning and judgment. Aricept, launched worldwide in 1997, and Exelon, which has been cleared for marketing in almost 50 countries, do not have the serious side effects, such as liver toxicity, associated with Cognex. Cognex was launched in late 1993 and had worldwide sales last year of $12 million. Aricept had sales of more than $380 million. There have been no head to head trials of Aricept and Exelon, Novartis said.