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FDA Approves Botox Rival

The Food and Drug Administration has approved a rival to Botox, the blockbuster wrinkle-reducing drug from Irvine-based Allergan Inc.

Medicis Pharmaceutical Corp. of Scottsdale and its partner, France’s Ipsen SA, said Thursday that regulators approved their Dysport drug as an anti-wrinkle treatment and for treating spasms of the neck muscles.

The FDA originally was set to decide on the marketing application for Dysport in mid-April. But that was delayed as Medicis and Ipsen still were in talks with regulators about labeling and detailing of side effects, which led to worries about a potential approval delay.

Medicis said it expects to launch the cosmetic form of the drug, which will use the Dysport name instead of the previously proposed Reloxin, within the next 30 to 60 days.

Ipsen is expected to launch the medical form of Dysport during the second half of the year.

Allergan’s shares fell 3% in early afternoon New York trading with a market value of $14 billion, while Medicis’ shares were up 14% with a market value of $877 million.

Analysts expect Medicis to launch cosmetic Dysport at a lower price than Botox and eventually expect it will grab 20% to 30% of Botox’s market share.

Botox sales for medical and cosmetic uses totaled $1.31 billion in 2008. Allergan has projected lower Botox sales of $1.15 billion to $1.19 billion in the wake of the economic slowdown for 2009.

Allergan is scheduled to report its first-quarter results Friday.

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