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Allergan’s Botox Migraine FDA Review Extended 3 Months

August 2, 2010 |

IAPAM News: Aug. 2 (Bloomberg) — Allergan Inc. said U.S. regulators extended by three months a review of its top product, the wrinkle-smoother Botox, for a new use as a migraine treatment. The U.S. Food and Drug Administration asked for information on safety monitoring of Botox as a migraine treatment and requested doctor training, the Irvine, California-based company said in a statement. Allergan said it gave that information to the FDA, without specifying a decision date.

Botox may generate an additional $1 billion in revenue as a migraine remedy, said Sanford C. Bernstein & Co. analyst Aaron Gal. The drug had $1.3 billion in sales last year. About 2.9 million Americans have migraines, and they are usually treated with over-the-counter painkillers, as well as Johnson & Johnson’s Topamax and GlaxoSmithKline Plc.’s Imitrex. Doses of Botox for headaches are bigger than for aesthetic use, Gal said.

“This is a fairly large patient population and a significant unmet need for a severe condition, so a drug with material help is going to get high usage,” Gal said in a telephone interview before today’s announcement. “Add to that the higher dosing. It’s a very major indication.”

The shares increased $4.25, or 7 percent, to $65.31 at 9:42 a.m. in New York Stock Exchange composite trading. Also today, Allergan reported second-quarter earnings excluding certain items of 85 cents a share, beating by 4 cents the average estimate of 15 analysts surveyed by Bloomberg.

20 Percent

The migraine indication alone could be worth as much as 20 percent of Allergan’s revenue in five years, he said.

Botox was first cleared for U.S. sale in 1989 as a treatment for eye muscle spasms. The drug won an added approval in April 2002 as a tool to eliminate wrinkles.

The drug, a purified form of the poison botulinum, is administered by doctors as an injection. It helps to smooth wrinkles in facial skin by paralyzing the muscles underneath. Scientists don’t know how Botox helps to prevent migraines.

About 12 percent of the U.S. population experiences migraines, according to the National Institutes of Health. The painful headaches last from 4 to 72 hours, with additional symptoms that include sensitivity to light, noise and odors. In two studies, migraine patients who were injected with Botox had fewer days per month with headaches of any kind, compared with placebo.

In one medical trial, patients on Botox had 7.8 fewer days per month afflicted with any headaches including migraines, compared with 6.4 fewer headache days on placebo. In a second, patients getting Botox injections had 9 fewer days of headaches per month, compared with 6.7 with a dummy treatment, according to results reported September 2009 at the International Headache Congress in Philadelphia.

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