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AEterna Zentaris and Sanofi-Aventis Sign a Development, Commercialization and Licensing Agreement for Cetrorelix in Benign Prostatic Hyperplasia
Date:3/6/2009

anges in sexual function. Other important endpoints include plasma changes in levels of testosterone, and assessment of other adverse events.

The third study in the Phase 3 program, a multi-center safety study, for which patient recruitment was completed in December 2008, is an ongoing open-label, single-armed study involving 529 patients in North America. The lead investigator is Joel Kaufman, M.D., Associate Clinical Professor in Urology at University of Colorado School of Medicine in Denver, Colorado and at Urology Research Options in Aurora, Colorado.

First efficacy results are expected during the third quarter of 2009 with an NDA filing targeted in 2010.

About Cetrorelix

Cetrorelix pamoate is an investigational agent that has shown in Phase 2 studies to provide fast and long lasting relief of BPH symptoms and was well tolerated, with a low incidence of sexual side effects. Cetrorelix is part of AEterna Zentaris' luteinizing hormone-releasing hormone (LHRH) antagonist therapeutic approach. This peptide-based active substance was developed by the Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently of the U.S. Veterans Administration in Miami.

Cetrorelix acetate is marketed under the brand name Cetrotide(R), the first LHRH antagonist approved for therapeutic use as part of in vitro fertilization programs (controlled ovulation stimulation/assisted reproductive technologies) in Europe, the USA and Japan. It was launched on the market through Serono (now Merck Serono) in the U.S., Europe and in several other countries, as well as in Japan through Shionogi.

About Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging men - affecting more than 20 million men in the United States - but its etiology is far from being completely understood. Data from ongoing research suggest BPH and lower uri
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SOURCE AETERNA ZENTARIS INC.
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5. AEterna Zentaris Agrees to Sell Cetrotide(R) Royalty Stream for $52.5 Million to Cowen Healthcare Royalty Partners
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9. AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia
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