QUEBEC CITY, April 29 /PRNewswire-FirstCall/ -- AEterna Laboratories Inc. (TSX: AEL; NASDAQ: AELA), along with its wholly-owned subsidiary Zentaris GmbH, today announced statistically significant positive results from a recently completed Phase II clinical program designed to evaluate cetrorelix, a luteinizing hormone releasing hormone (LHRH) antagonist, in three different indications: endometriosis, pre-surgical treatment of uterine myomas and benign prostatic hyperplasia (BPH), that can benefit from a targeted and controlled decrease in sex hormones, including estrogen and testosterone. The positive results of six Phase II trials, which also demonstrated good tolerability in all indications, will form the basis for further development of cetrorelix in different indications through collaboration with Solvay Pharmaceuticals, the Company's worldwide (ex-Japan) exclusive development and marketing partner for cetrorelix for the above indications.
Detailed Phase II data with new depot formulation of cetrorelix in endometriosis and in pre-surgical treatment of uterine myomas will be presented during the 18th World Congress of the International Federation of Fertility Societies (IFFS), which will be held in Montreal, Canada, on May 23- 28, 2004.
"The striking results we have seen with cetrorelix in these trials, particularly in endometriosis, deliver on the promise of LHRH antagonists and are the culmination of many years of research and development efforts which originated from Dr. Schally's Nobel-Prize winning research into LHRH and its antagonists," said Prof. Jurgen Engel, Chairman & Managing Director of Zentaris GmbH, Executive Vice President R&D and Chief Operating Officer at AEterna. "Unlike other LHRH antagonists currently on the market or in clinical development, cetrorelix has a unique profile, avoiding total reduction (castration) of the different hormone levels. In addition, modulation of the epidermal growth factor receptor (EGFr) levels by cetrorelix has been shown in myoma cells, an effect that could be broadly applicable outside the cancer area."
"We are very excited about these positive Phase II results and are preparing a development plan in the different indications to expedite the registration of cetrorelix. We are especially enthusiastic about endometriosis for which no good treatment is currently available," stated Dr. Werner Cautreels, Solvay Pharmaceuticals' Global Head of R&D.
According to Gilles Gagnon, President and Chief Executive Officer at AEterna, "Cetrorelix, together with perifosine, form the cornerstone of our pipeline and, as such, we are very excited about the prospect of seeing cetrorelix enter pivotal trials in major markets. We look forward to further leveraging the depth and breadth of the product pipeline that we obtained through the acquisition of Zentaris to continue to deliver benefits to patients and value to our shareholders."
The placebo-controlled study demonstrated that cetrorelix use was associated with a rapid and durable therapeutic response, namely improvement of endometriosis-related symptoms, such as pelvic pain, extending up to several months following only two intramuscular injections of cetrorelix with a one month interval.
The Company believes that the clinical data indicate that cetrorelix, unlike currently used treatments for endometriosis such as LHRH agonists, is suitable for long-term use as an intermittent treatment for endometriosis.
Endometriosis is the growth of the endometrium, or the inside lining of the uterus, outside of the uterus and is dependent upon the level of estrogen. Endometriosis affects approximately 10% to 20% of women of child-bearing age, and there is still a high medical need for new treatments. The total market size in 2003 was estimated to be around US$800 million.
Placebo-controlled trials have demonstrated that subcutaneous administrations of cetrorelix lead to the reduction of myoma/uterine volume within one month only.
Uterine myoma is a benign tumor of the uterus which is composed of muscle tissue. The growth of uterine myomas depends on the level of estrogen. Approximately 15% of all women of child-bearing age have uterine myomas. It is estimated that more than US$150 million are spent annually on drug treatment.
Benign Prostatic Hyperplasia (BPH)
Two placebo-controlled Phase II trials were conducted in BPH. As early as one month following initiation of therapy, data from both trials demonstrated a dose-dependent improvement of clinical symptoms, including IPSS (International Prostate Symptom Score) and maximum uroflow in the cetrorelix treatment group, in comparison with the placebo group, and the positive effect lasted three months without additional administration of cetrorelix. Furthermore, the use of cetrorelix was associated with a slight reduction of prostate size and did not have an adverse influence on sexual activity or libido.
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. In 2004, the amount spent on drug treatment is expected to be around US$1.8 billion.
About Solvay Pharmaceuticals
Solvay Pharmaceuticals is a member of the Solvay group of pharmaceutical and chemical companies. Operating globally with corporate offices in Europe, the U.S. and Japan, and sales and marketing companies in more than 45 countries, Solvay Pharmaceuticals employs 7,500 people worldwide. It has research and development activities concentrated onto carefully selected clinical targets in the fields of psychiatry, gastroenterology, cardiology and gynaecology. The Solvay Group employs more than 30,000 people in three sectors of activity: pharmaceuticals, chemicals and plastics. For further information on Solvay, please visit the websites http://www.solvay.com/ or http://www.solvaypharmaceuticals.com/ .
About AEterna Laboratories
AEterna Laboratories Inc., along with its wholly-owned subsidiary Zentaris GmbH, is a biopharmaceutical company with an extensive product portfolio, including two marketed products and 14 other product candidates under development in oncology, endocrinology and infectious diseases. Cetrorelix (Cetrotide(R)) is sold in the U.S., Europe and several other countries to the in vitro fertilization market, and is in Phase II clinical trials for endometriosis, uterus myoma and enlarged prostate (BPH). Miltefosine (Impavido(R)) is sold for black fever and has successfully completed a Phase III trial in parasitic skin disease. Neovastat(R) is in a Phase III trial for non-small cell lung cancer. Perifosine, the first orally- active AKT inhibitor, is in Phase II trials for multiple cancers. Several other clinical programs are underway with various potential development candidates, supported by a worldwide network of scientific and marketing partnerships. Furthermore, AEterna benefits from a discovery platform of 100,000 molecules, which is generating promising new compounds.
AEterna also owns 62% of its subsidiary Atrium Biotechnologies Inc. which develops and markets active ingredients and speciality fine chemicals in the health and personal care industry for the cosmetics, chemical, pharmaceutical and nutritional industries. Its international business network and portfolio of over 1,000 products sold to over 2,000 institutional customers and to over 36,000 physicians and other health care professionals, have generated significant growth in sales and earnings since the Company was founded in January 2000. In 2003, Atrium sales exceeded $120 million.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ National Market (AELA). News releases and additional information about AEterna are available on its Web site at http://www.aeterna.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-
AETERNA LABORATORIES INC.