AEterna Zentaris is responsible for filing NDA, which it anticipates in 2010.
Sanofi-aventis obtained U.S. rights to AEterna Zentaris’ luteinizing hormone-releasing hormone (LHRH) antagonist for the treatment of benign prostatic hyperplasia (BPH). AEterna Zentaris is responsible for the ongoing Phase III trial. First efficacy results are expected this year.
AEterna Zentaris will also take care of regulatory filings; an NDA submission is expected in 2010. Sanofi-aventis will undertake commercialization and post-approval studies. AEterna Zentaris retains certain rights to co-promote the product in the U.S.
Under the terms of the agreement, sanofi-aventis will make up-front and future milestone payments, and AEterna Zentaris will be eligible for royalties.
Cetrorelix pamoate is designed as a long-acting intramuscular injection. Late-stage investigations are taking place in Canada, the U.S., and Europe.
“This deal complements our strong presence in the urology space with Uroxatral, Eligard, and Cialis, co-promoted with Eli Lilly,” remarks Brent Ragans, vp, general therapeutics business unit at sanofi-aventis U.S.