Lausanne, Switzerland, December 2, 2003 — Debiopharm S.A. (Debiopharm) agreed to reacquire from Pfizer Inc (Pfizer) the sales and marketing rights to Trelstar® Depot 3.75mg one month formulation, and Trelstar® LA 11.25mg, the three month formulation, in the United States, Canada and Mexico. Debiopharm had previously licensed the rights to Trelstar to Pharmacia Corp. and Pfizer obtained these rights through its acquisition of Pharmacia in April 2003.
Trelstar Depot 3.75mg (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist, is a controlled release one month formulation, approved by the U.S. Food and Drug Administration (FDA) in June 2000 for the treatment of advanced prostate cancer. Trelstar® LA 11.25mg, the three month formulation, obtained FDA approval one year later. The Trelstar® patent expires in 2010 in the United States. Triptorelin is marketed in Europe as Decapeptyl® and is a market leader in Southern Europe. Both products received J-code designation in January 2003. J-code designation allows providers to accurately price and process claims, and to get faster reimbursements.
Trelstar® LA is manufactured at Debio R.P. in Switzerland at a state-of-the-art facility, using Debio’s proprietary solvent-free process, which was developed specifically for this product. Debio continues to work on innovative formulations to release triptorelin over longer periods of time and is testing new combinations and new uses of the product.
“With an LHRH agonist market of over US$1 billion, we believe that there is a very high potential for Trelstar® in North America,” said Dr. R.-Y. Mauvernay, CEO and president of Debiopharm. “Debiopharm looks forward to working with another pharmaceutical company to make Trelstar®, a proven product, available to a larger patient population in the US, Canada and Mexico. We would like to have such a partner in place for a launch of Trelstar® in early 2004.” Pfizer will continue to distribute Trelstar until this time.
Prostate cancer is the most common cancer found in American men, after skin cancer. The American Cancer Society estimates that there will be about 220,900 new cases of prostate cancer in the United States in 2003. More than 75% of all prostate cancer cases are diagnosed in men over age 65, and the disease is most common in North America and Northwestern Europe. Recent genetic studies suggest that strong familial predisposition may be responsible for 5% to 10% of prostate cancers.
About Debiopharm S.A.
Debiopharm, Debio R.P. and Debioclinic are an established and proven group of three synergistic and complementary companies, that have a successful track record in developing, registering and ensuring that new chemical entities are brought to market both in Europe and in the United States. Products successfully registered and launched include oxaliplatin for advanced colorectal cancer and triptorelin pamoate for prostate cancer, both market leaders in their therapeutic areas. Specialized in oncology, hormonal and niche products for serious medical conditions, Debiopharm is a partner of research institutions, pharmaceutical and biotechnology companies who seek to develop and register their drugs. Debio R.P., Debiopharm’s sister company, is a leading world player in the research, development and manufacturing of polymer-based controlled release injectable formulations for peptides and proteins, including proprietary technologies suitable for other therapeutic modalities such as soluble polymer cytotoxic-drug conjugates for parenteral administration. Debio R.P. also carries out scale-up under current good manufacturing practice (cGMP) and has an FDA-inspected plant. Debioclinic, the third Debio company, is a contract research organisation fully dedicated to clinical development. For more information, please visit the company’s website at: www.debio.com