Lausanne, Switzerland, May 24, 2007 – Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist in oncology and serious medical conditions, announces the successful completion of the European Mutual Recognition Procedure (MRP) for Salvacyl®/Moapar® 3-month sustained release formulation, in Germany, Belgium, Denmark, Finland, France, Norway, the Netherlands and the United Kingdom. Last year, Salvacyl®/Moapar® was approved in Sweden, which was the reference member state for the MRP. Debiopharm is seeking a commercial partner for the sales and marketing of this product.
Salvacyl®/Moapar®, a gonadotropin releasing hormone (GnRH) agonist analogue, is effective in the treatment of sexual deviations in adult men by inducing and maintaining a reversible reduction of testosterone to castrate serum levels. In the treatment of sexual deviations in men, administration of Salvacyl®/Moapar® every 3 months is an advantage over daily oral forms or intra-muscular weekly injections required with antiandrogens such as cyproterone acetate (CPA) and medroxyprogesterone acetate (MPA).
Salvacyl®/Moapar® has shown fewer side-effects compared to antiandrogens (CPA and MPA), including a lower risk of hepatocellular damage, thromboembolism and gynecomastia. Except for uncommon immuno-allergic and injection site reactions, Salvacyl®/Moapar® revealed no other risks than those known to be related to the induced hypogonadism.
Two studies have shown that regular injections of the active ingredient, triptorelin, over a period of eight months to seven years in 36 young male patients with sexual deviations demonstrated a good efficacy and safety profile. Triptorelin produced reversible serum castrate testosterone levels (defined as ≤1.735 nmol/L) in all patients, and concurrently with the decrease in testosterone levels, triptorelin treatment abolished deviant sexual behaviours in 35/36 patients with severe sexual deviations.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.6 billion in 2006.
For more information on Debiopharm Group, please visit: www.debiopharm.com