Healthcare Industry News: erectile dysfunction
News Release - June 21, 2006
AEterna Zentaris Receives Green Light from FDA to Move Forward into Phase 3 Program with Cetrorelix in BPHCompany plans to submit IND over the next few months
QUEBEC CITY, June 21 (HSMN NewsFeed) - AEterna Zentaris Inc. (TSX: AEZ ; Nasdaq: AEZS ) today announced that during a recent end of Phase 2 meeting, the U.S. Food & Drug Administration (FDA) reviewed the safety and efficacy data from an extensive Phase 2 program with cetrorelix, its lead luteinizing hormone-releasing hormone (LHRH) antagonist product candidate, for the treatment of benign prostatic hyperplasia (BPH). Accordingly, the Company plans to submit an Investigational New Drug (IND) application to the FDA within the next few months for the initiation of a Phase 3 program for cetrorelix in BPH.
"We are very excited and encouraged with the outcome of our recent meeting with the FDA, which, we believe, will allow us to further pursue the development of cetrorelix in BPH with a Phase 3 program," commented Dr. Jurgen Engel, Executive Vice President, Global R&D and Chief Operating Officer at AEterna Zentaris. "Cetrorelix has shown promising and compelling results in our extensive Phase 2 program, and we now look forward to bringing it to its final development stage."
Gilles Gagnon, President & Chief Executive Officer at AEterna Zentaris, stated, "We continue to commit our resources as we aggressively advance our promising product candidates through our pipeline and pursue our strategy of becoming a late-stage biopharmaceutical company before year-end. Our successful meeting with the FDA regarding cetrorelix marks a major milestone for the Company and is further proof of the significant potential of our LHRH antagonist therapeutic approach. Our LHRH-antagonist platform remains a priority. We look forward to announcing the acceptance of our Investigational New Drug application from the FDA over the next few months for our Phase 3 program with cetrorelix, as well as plan to disclose Phase 2 results for our other promising LHRH-antagonist product candidate, ozarelix in prostate cancer, over the next few weeks," concluded Mr. Gagnon.
About Benign Prostatic Hyperplasia (BPH)
Benign prostatic hyperplasia (BPH) is characterized by an abnormal benign growth of the prostatic tissues caused by testosterone. Symptoms linked to BPH include pain while urinating and frequent urges to urinate during the night and sometimes, kidney problems. In some cases, if left untreated, BPH may develop into prostate cancer. BPH affects more than 50% of men 60 years and over, with approximately 56 million cases in the U.S., Europe and Japan. In 2004, BPH treatment represented a market size of US$2.6 billion. Contrary to most of the present treatments for BPH, cetrorelix is not associated with side effects such as erectile dysfunction, loss of libido and chemical castration. According to Decision Resource, cetrorelix is currently the most advanced LHRH- antagonist in development for the treatment of benign prostatic hyperplasia.
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 Professor Andrew Schally of the U.S. Veterans Administration in Miami.
Cetrorelix is marketed under the brand name Cetrotide®, 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 S.A. in the USA, Europe and in several other countries.
Cetrorelix is currently in a pivotal clinical program for endometriosis sponsored by our partner, Solvay.
In addition to the planned Phase 3 program in BPH, cetrorelix is in a Phase 2 trial program in Japan, sponsored by our partners, Shionogi and Nippon Kayaku.
About Cetrorelix Successful Phase 2 Program
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 has successfully completed a broad 7-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.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a growing global biopharmaceutical company engaged in the discovery, development and marketing of therapies for cancer and endocrine disorders. AEterna Zentaris also owns 48.29% of the equity of Atrium Biotechnologies Inc. (TSX: ATB ) and 64.7% 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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