FDA accepts Reloxin BLA, Ipsen gets $25M

French drugmaker Ipsen and US partner Medicis say that the Food and Drug Administration has accepted the filing of the former's Biologics License Application for Reloxin, its botulinum toxin type A product for esthetic use. The acceptance for the anti-wrinkle injection signifies the start of the review process of the dossier.

In accordance with the agreement between the two parties, Medicis will pay Ipsen $25.0 million in light of the announcement. Subject to approval of the BLA, the US firm will pay a further $75.0 million and will commercialize Reloxin in its home market.

Ipsen submitted the BLA to the agency a few months ago (Marketletter March 24). This is intended to address the concerns cited by the agency when it declined to file the Reloxin BLA earlier this year, after local partner Medicis submitted it late 2007 (Marketletter February 11). A standard response from the FDA is expected 10 months after submission.