FDA has accepted Reloxin filing, says Ipsen

PARIS — Ipsen, the French pharmaceuticals firm, on Tuesday said the FDA has accepted the filing of its Biologics License Application for Reloxin, its variation on botulinum toxin type A, for cosmetic treatment in the United States.

If the FDA's review of the applications passes without a hitch, Reloxin could be launched in the US in early 2009, according to Natixis Securities analysts.

Medicis Pharmaceutical Corp will pay Ipsen approximately $25 million in connection with the announcement.

Subject to approval of the BLA by the FDA, Medicis will pay Ipsen a further $75 million and will commercialize the Botox product in the U.S.

As of April, Reloxin already is approved for aesthetic indications in 23 other countries, Ipsen said.

SOURCE: Thomson/Reuters