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Allergan jumps as Botox migraine OK seems closer

http://www.reuters.com/article/idCNN0226297820100802?rpc=44

Mon Aug 2, 2010 5:23pm EDT

* FDA seeks info on Botox anti-migraine risk strategy

* FDA to delay Botox migraine decision by 3 months

* Analysts see FDA more inclined toward approval

* Shares rise 6 percent (Adds doctor comments, closing shares)

By Ransdell Pierson

NEW YORK, Aug 2 (Reuters) - U.S. regulators seem inclined to approve Allergan Inc's (AGN.N) wrinkle drug Botox to prevent migraine headaches in millions of Americans, industry analysts said, based on information the drugmaker released on Monday.

Allergan shares rose 6 percent after it said the U.S. Food and Drug Administration requested information on how to safely market Botox for the extremely painful, recurring headaches. It gave details of the request as it reported better-than-expected quarterly results.

"The stock market is thinking that the FDA's request for risk-management information is a precursor to FDA approval" for migraines, said Credit Agricole Securities analyst David Maris.

"The market is excited because it's wondering why would the FDA ask for a program for training physicians if it wasn't going to approve it."

Investors had expected the FDA's decision on Botox by Monday and see the added indication propelling sales of Allergan's biggest product. In Allergan's latest quarter, Botox sales rose 7 percent to $361 million. Analysts believe approval for the condition could boost its annual sales by $500 million or more.

About 18 percent of U.S. women and 6 percent of men have migraine headaches at some time each year, according to the Merck Manual of medical information.

Botox would be meant for the estimated three million Americans who have chronic migraines, meaning 15 or more headache days per month.

Allergan said the FDA will delay its decision for three months after asking the company for an updated Risk Evaluation and Mitigation Strategy on how to safely market Botox for potential anti-migraine use.

Allergan has already provided the FDA with the requested information, including a proposed plan on how to train physicians for the new use of Botox.

"We believe this strongly suggests that (the) FDA will approve Botox for migraine without requesting another study," Wells Fargo analyst Larry Biegelsen said in a research note.

In clinical trials, Botox was given every 12 weeks to prevent migraines, via 31 injections into seven areas of the head and neck.

In one late-stage trial, Botox failed its primary goal of reducing the number of headache episodes compared with a placebo. But it met a secondary goal, as those on Botox had headaches on average 7.8 fewer days each month, compared with a drop of 6.4 days among patients taking placebo.

In a second trial, Botox patients had nine fewer headache days compared with a drop of 6.7 days for the placebo group.

Botox seems to block brain messenger chemicals, called neurotransmitters, that transmit pain, said Dr. David Simpson, a professor of neurology at Mount Sinai Medical Center.

"Current drugs to prevent migraines are far from perfect, so this is a potential significant advance," said Simpson, who has been a consultant for Allergan on unrelated Botox studies.

BRITAIN PAVES PATH FOR NEW BOTOX USE

Britain three weeks ago became the first country to approve Botox for migraines. Wall Street expects other European countries to follow, and for the new Botox use to boost the product's sales by as much as $300 million a year in Europe.

Its approval in the larger and more lucrative U.S. market has been considered far less certain, given the FDA's greater concern with safety in recent years after the recall of Merck & Co Inc's (MRK.N) widely used Vioxx arthritis drug.
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