Healthcare Industry News: benign prostatic hyperplasia
News Release - March 6, 2009
Sanofi-aventis and AEterna Zentaris Sign Agreement in the U.S.Development and Commercialization for Cetrorelix Pamoate in benign prostatic hyperplasia
BRIDGEWATER, N.J., March 6 (Healthcare Sales & Marketing Network) -- Sanofi-aventis U.S. announced today the signing of an agreement with AEterna Zentaris GmbH for the development, registration and marketing of cetrorelix pamoate, a luteinizing hormone-releasing hormone (LHRH) antagonist, for the treatment of benign prostatic hyperplasia (BPH), in the U.S.
Cetrorelix pamoate, a long-acting intramuscular injection, is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. In Phase 2 studies, cetrorelix pamoate was well-tolerated and provided fast and long-lasting relief of BPH symptoms with a low incidence of sexual side effects. First efficacy results from the Phase 3 program are expected during 2009 with potential for NDA submission in 2010.
BPH, commonly known as enlarged prostate, is a non-cancerous enlargement of the prostate, affecting more than 20 million men in the U.S. alone. Currently available therapies may improve symptoms to some degree, but often come with sexual and other side effects.
"We are pleased to have the potential to bring this innovative therapy for BPH to the U.S. market," stated Brent Ragans, Vice President, General Therapeutics Business Unit at sanofi-aventis U.S. "This deal complements our strong presence in the urology space with Uroxatral(R) (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."
AEterna Zentaris will be responsible for completing the Phase 3 program and regulatory submission in the U .S. Sanofi-aventis will be responsible for all commercial activities, including Phase 3b and Phase 4 trials, and will book sales in the U.S. AEterna Zentaris has retained certain rights to co-promote the product in the U.S.
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.
This collaboration reinforces sanofi-aventis commitment to strengthening its areas of expertise and to further develop its growth potential through external licensing opportunities.
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY ).
For more information, http://www.sanofi-aventis.us/ or www.sanofi-aventis.com
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