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.