Medicis, Ipsen Reveal Submission Of Reloxin BLA In Aesthetics To FDA - Quick Facts

(RTTNews) - Medicis (MRX | news | PowerRating | PR Charts ) and Ipsen announced Monday that Ipsen has submitted a Biologics License Application or BLA for the botulinum toxin type A, Reloxin, in aesthetic indications to the U.S. Food and Drug Administration.

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. Subject to approval of the BLA by the FDA, Medicis plans to commercialize Reloxin in the U.S. in accordance with the long-standing arrangement between Medicis and Ipsen.

In March 2006, Ipsen granted Medicis the rights to develop, distribute and commercialize Ipsen's botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians. Following the FDA's acceptance of the Reloxin submission, Medicis will pay Ipsen approximately $25 million in accordance with the agreement between the parties.

Jonah Shacknai, Chairman and Chief Executive Officer of Medicis, said, " We continue to believe the Reloxin BLA is strong, and anticipate entering in the growing, multi-million dollar aesthetic botulinum toxin market in the U.S. upon FDA approval."

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