Ipsen clears FDA hurdle, gains $25M for Reloxin BLA

France's Ipsen gained $25 million from Medicis Pharmaceutical on the news that the FDA has accepted the BLA filing for Reloxin, a next-gen competitor to Allergan's Botox. And analysts say the therapy could be launched in the second quarter of 2009--provided the FDA review goes without a hitch. An approval would be worth an additional $75 million milestone payment from Medicis, the U.S. partner for the cosmetic therapy. Reloxin is already approved in 23 countries.

The therapy is botulinum toxin type A, which is used to erase frown lines. That market was worth $1.2 billion in Botox sales last year. Temporarily paralyzing the nerves in the face is worth $400 per injection in the U.S., with big annual increases in sales. Analysts, though, are wondering if a recession might bring the frown lines back among hard-pressed consumers.

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