– Presentation of Efficacy and Safety Phase III Results –
Lausanne, Switzerland, February 12, 2008 – Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist focusing on serious medical conditions and particularly oncology, presented today at the 9th International Symposium on GnRH in Berlin, Germany, the results of a phase III study with its new 6-month formulation of Decapeptyl®/Trelstar® (triptorelin), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of advanced prostate cancer. These results show similar efficacy and safety to the already marketed 1- and 3-month formulations.
This multicenter, open, non-comparative, phase III study on the efficacy and safety of two consecutive injections of triptorelin 6-month formulation in 120 patients with advanced prostate cancer, showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < 1.735 nmol/L or 50 ng/dL) from week 8 to 48. These efficacy results are similar to those obtained previously with repeated administrations of the 1- and 3-month formulations of triptorelin. Furthermore the adverse event profile of the new 6-month formulation of triptorelin is fully comparable to that observed with the 1- and 3-month formulations.
“Our 1- and 3-month formulations of Decapeptyl® and Trelstar® are used worldwide in the treatment of prostate cancer. However they require one injection every 4 or 12 weeks respectively. The 6-month formulation will improve patient compliance and increase convenience and comfort with the need of only one intramuscular injection every 24 weeks” said Kamel Besseghir, CEO of Debiopharm S.A.
Triptorelin was licensed-in from Tulane University in 1982. Debiopharm developed and submitted a 1- and 3-month sustained release formulation of triptorelin embonate in Europe and the United States. The product is now marketed worldwide for the treatment of advanced prostate cancer, endometriosis, precocious puberty, in-vitro fertilisation programs, and uterine fibroids. Licensees include Ipsen, Watson, Ferring, Tecnofarma, Aché, Rowfarma and Sidus. Current licensee sales are of US $300M.
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.