AEterna Zentaris Announces Initiation of a European Multi-Center Phase II Trial of D-63153 in Benign Prostate Hyperplasia QUEBEC CITY, Canada, April 13 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the initiation of a European multi- center, placebo-controlled Phase II trial to evaluate the efficacy, as well as the safety and tolerability of D-63153, a fourth generation LHRH (Luteinizing Hormone Releasing Hormone) antagonist, in patients with benign prostate hyperplasia (BPH). The double-blind placebo-controlled Phase II trial will evaluate the efficacy of D-63153 as measured by its effects on clinical signs and symptoms characteristic of BPH, including the International Prostate Symptom Score (IPSS) and maximum uroflow, as well as the durability of therapeutic response over several months. This trial will be fully funded by Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), AEterna Zentaris' U.S. development partner for D-63153. "We are very pleased to see the timely initiation of this second Phase II trial of D-63153 now in benign prostate hyperplasia (BPH), on the heels of the Phase II trial initiation of hormone-dependent prostate cancer Phase II study announced earlier this week," said Prof. Jurgen Engel, Executive Vice President, Global R&D and COO of AEterna Zentaris. He added: "Furthermore, we believe that D-63153 which allows for chronic intermittent treatment has the potential to improve clinical symptoms of BPH while overcoming some of the limitations associated with currently marketed therapies, including the need for daily administration and side effects such as erectile dysfunction and loss of libido." Gilles Gagnon, President and Chief Executive Officer of AEterna Zentaris added: "Today's announcement completes the full deployment of our strategy with our LHRH-antagonist therapeutic approach. With this multi-product strategy combined with our multi-partner approach, we are now in a position to further advance on a worldwide basis the clinical development of all of our LHRH-antagonist compounds in commercially attractive indications such as endometriosis, BPH and prostate cancer. About Benign Prostate Hyperplasia (BPH) Benign prostate hyperplasia is characterized by an abnormal, but not malignant, testosterone-mediated growth of prostate tissue. BPH is estimated to affect approximately 33 million men over 60 years of age. This year, the amount spent on drug treatment for this condition is expected to be around US$1.8 billion. About D-63153 strategic alliance with Spectrum Pharmaceuticals In August 2004, AEterna Zentaris granted to Spectrum Pharmaceuticals an exclusive license to develop and market D-63153 for all potential indications in North America (including Canada and Mexico) and India. AEterna Zentaris received an upfront payment which included cash and equity of Spectrum, at signature, and is eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to royalties on potential net sales. AEterna Zentaris retains exclusive rights to the rest of world and will share with Spectrum upfront and milestone payments, royalties or profits from potential sales in Japan. About AEterna Zentaris Inc. AEterna Zentaris Inc. is an oncology and endocrine therapy focused biopharmaceutical company with proven expertise in drug discovery, development and commercialization. The Company's broad 20 product pipeline leverages five different therapeutic approaches, including LHRH antagonists and signal transduction inhibitors. The lead LHRH antagonist compound, cetrorelix, is currently marketed for in vitro fertilization under the brand name Cetrotide(R). Cetrorelix is also in late-stage clinical development for endometriosis and benign prostatic hyperplasia (BPH). The lead signal transduction inhibitor compound, perifosine, is an orally-active AKT inhibitor that is in several Phase II trials for multiple cancers. AEterna Zentaris also owns 50.7% of Atrium Biotechnologies Inc. (TSX: ATB.sv), a leading developer, manufacturer and marketer of value-added products for the cosmetics, pharmaceutical, chemical and nutritional industries. News releases and additional information about AEterna Zentaris are available on its Web site http://www.aeternazentaris.com/ . Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. DATASOURCE: AETERNA ZENTARIS INC. 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