Healthcare Industry News: Solvay Pharmaceuticals
News Release - April 20, 2006
AEterna Zentaris Gains Market Approval for Cetrotide(R) (cetrorelix) in Japan for In Vitro FertilizationQUEBEC CITY, April 20 (HSMN NewsFeed) - AEterna Zentaris Inc. (TSX: AEZ ; NASDAQ: AEZS ) today announced it gained market approval for Cetrotide® (cetrorelix) in Japan for in vitro fertilization. Cetrotide® (cetrorelix) will be manufactured and marketed in Japan by partners Nippon Kayaku Co., Ltd. and Shionogi & Co., Ltd. AEterna Zentaris obtained an undisclosed milestone payment from its partners and will receive revenues from the supply of Cetrotide® (cetrorelix) to its Japanese partners. Cetrotide® (cetrorelix) is expected to be launched in Japan by year-end.
Cetrotide® (cetrorelix) has been marketed worldwide (ex-Japan) by Serono S.A. (NYSE: SRA ) since 1999, providing AEterna Zentaris with annual revenues of over US$20 million per year.
"We are very pleased that Cetrotide® (cetrorelix) has been approved for in vitro fertilization in Japan and also very proud to work with such highly respected partners as Nippon Kayaku and Shionogi to ensure the successful commercialisation of our product on the Japanese market. This approval marks a significant achievement for AEterna Zentaris as Cetrotide® (cetrorelix) is now approved worldwide and further demonstrates our ability to develop and market novel efficient therapies for conditions affecting millions of people around the world," said Gilles Gagnon, President and Chief Executive Officer at AEterna Zentaris.
Dr. Jurgen Engel, Executive Vice President Global R&D and Chief Operating Officer at AEterna Zentaris stated, "Cetrotide® (cetrorelix) has a well- established safety profile with over 250,000 women treated worldwide. The approval of Cetrotide® (cetrorelix) in Japan, coupled with our focused development strategy for this product, further validates our world class development capabilities. We believe this product has great potential in additional benign indications as cetrorelix is currently in mid-to late-stage clinical development for the treatment of benign prostate hyperplasia (BPH) and endometriosis. We are encouraged by the prospects of cetrorelix and look forward to further advancing this product throughout the year.
About Cetrotide® (cetrorelix)
Cetrotide® (cetrorelix) was the first luteinizing hormone-releasing hormone (LHRH) antagonist treatment approved for in vitro fertilization. It is administered to women to prevent premature ovulation in order to increase fertility success rate. Developed in cooperation with Medicine Nobel-Prize winner, Professor Andrew Schally, of Veterans Affairs, Miami, Florida, it was launched in Europe in 1999 and in the United States in 2001. Cetrotide® (cetrorelix) is currently marketed worldwide by Serono, except for Japan where it gained approval to be manufactured and marketed by Nippon Kayaku and Shionogi.
Cetrotide® (cetrorelix) is the only treatment in its class that offers a choice of two highly effective dosage strengths which enable precise control. Due to its immediate onset of action, Cetrotide® (cetrorelix) permits a simplified, more convenient and shorter treatment involving fewer injections and causing fewer side effects than other forms of in vitro fertilization treatment.
Cetrorelix is part of our luteinizing hormone releasing hormone (LHRH) antagonist therapeutic approach. This peptide-based active substance was developed by the Company in cooperation with Nobel-Prize winner, Professor Andrew Schally of Veterans Affairs, Miami, Florida.
Cetrorelix is currently in a pivotal clinical program for endometriosis with our partner, Solvay, as well as in a Phase 2 trial program for BPH in Japan, conducted by our partners, Nippon Kayaku and Shionogi.
For the treatment of BPH, cetrorelix has shown to adequately suppress the formation of the male sex hormone testosterone, which plays a principal role in cell growth of the prostate. Since cell growth is stopped, surgical removal of the prostate might be avoided. All studies performed so far with cetrorelix in patients with symptomatic BPH, revealed an improvement in symptoms as assessed primarily by the I PSS (International Prostate Symptom Score), an increase in urinary peak flow rate as well as a reduction in prostate volume. Studies have also shown the excellent safety and tolerability profile of cetrorelix.
Cetrorelix Successful Phase 2 Program
Cetrorelix has successfully completed a broad seven-Phase 2 program in BPH, endometriosis, and uterine myoma. This extensive clinical program involved 735 patients and yielded significant and medically important results. Rapid and durable responses were observed without chemical castration and cetrorelix proved to have an excellent safety and tolerability profile.
Overall, cetrorelix has shown to have a fast onset of action allowing for a shorter treatment period, which could translate into an intermittent/chronic therapy. Such long treatment-free intervals are actually supported by the results derived from multiple Phase 2 placebo-controlled studies.
Partners for Cetrorelix
Cetrorelix has been licensed exclusively to Solvay Pharmaceuticals worldwide (except Japan) for all indications with the exception of IVF/COS/ART, which rights belong to Serono, and BPH for which AEterna Zentaris Inc. holds exclusive worldwide (except Japan) rights. Japanese manufacturing and marketing rights are held by Nippon Kayaku and Shionogi for all potential indications.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a growing global biopharmaceutical company focused on oncology and endocrine therapy with proven expertise in drug discovery, development and commercialization.
AEterna Zentaris also owns 48.36% of the equity of Atrium Biotechnologies Inc. (TSX: ATB.sv ) and 64.77% of its voting rights. Atrium is a developer, manufacturer and marketer of science-based products for the cosmetics, pharmaceutical, chemical and nutritional industries.
News releases and additional information are available at www.aeternazentaris.com.
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.
Source: AEterna Zentaris
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