Ipsen and Medicis announce submission of Reloxin® BLA in aesthetics to the FDA

Ipsen and Medicis announce submission of Reloxin® BLA in aesthetics to the FDA

Medicis (NYSE:MRX) and Ipsen (Euronext: IPN) today announced that Ipsen has submitted a Biologics License Application (“BLA”) for the botulinum toxin type A, Reloxin® , in aesthetic indications (glabellar lines) to the U.S. Food and Drug Administration’s (“FDA”) Division of Dermatology and Dental Products, within the Center for Drug Evaluation and Research.

This BLA submission by Ipsen is intended to address the concerns cited by the FDA when it declined to file the Reloxin® BLA in January 2008, which Medicis had submitted in late 2007. Standard response timeframe from the FDA is expected approximately 10 months following receipt of the Reloxin® submission. Subject to approval of the BLA by the FDA, Medicis intends to commercialize Reloxin® in the U.S. in accordance with the long-standing arrangement between Medicis and Ipsen. Changes from the original BLA submission relate primarily to sponsorship and ownership of the filing. The substantive elements of the original submission remain unchanged.

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