Cetrorelix pamoate, a long-acting intramuscular injection, is currently in three Phase III trials involving more than 1,600 patients with symptomatic benign prostatic hyperplasia (BPH) in Canada, the US and Europe.
In Phase II studies, cetrorelix pamoate was well-tolerated and provided fast and long-lasting relief of BPH symptoms with a low incidence of sexual side effects, said Sanofi. First efficacy results from the Phase III program are expected during 2009 with potential for new drug application submission in 2010.
AEterna Zentaris will be responsible for completing the Phase III program and regulatory submission in the US. Sanofi-Aventis will be responsible for all commercial activities, including Phase IIIb and Phase IV trials, and will book sales in the US. AEterna Zentaris has retained certain rights to co-promote the product in the US.
Under the terms of the agreement, Sanofi-Aventis will make upfront and future milestone payments and AEterna Zentaris will be eligible for royalties on future product sales.
Brent Ragans, vice president of the general therapeutics business unit at Sanofi-Aventis US, said: “This deal complements our strong presence in the urology space with Uroxatral (alfuzosin), Eligard (leuprolide) and Cialis (tadalafil), co-promoted with Eli Lilly. Cetrorelix is a strategic fit with our urology specialty sales force which is highly experienced in the promotion of products for urologic health.”