BRIDGEWATER, N.J., March 6 /PRNewswire-FirstCall/ -- 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(R) (leuprolide) and Cialis(R) (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.
About sanofi-aventis
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, www.sanofi-aventis.us or www.sanofi-aventis.com
U.S. Contact:
Marc Greene
908-981-4780
marc.greene@sanofi-aventis.com
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Source: sanofi-aventis U.S.
CONTACT: Marc Greene, sanofi-aventis, +1-908-981-4780,
marc.greene@sanofi-aventis.com