LAUSANNE, Switzerland, September 25 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announces the filing of an application with the European Agencies for the approval of its new 6-month formulation of Decapeptyl(R) (triptorelin pamoate 22.5 mg), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer. Once approved, Decapeptyl(R) 6-month formulation will be marketed by Debiopharm's partners, such as Ipsen in most European Union countries.
"This submission in Europe of our first 6-month-formulation for the treatment of prostate cancer is another demonstration of Debiopharm's commitment to supporting and enhancing the life of cancer patients. With an injection every 24 weeks, patients will benefit from increased convenience and comfort," said Kamel Besseghir, CEO of Debiopharm S.A. "Furthermore, upon approval, our newly built production line will be ready to manufacture the drug for worldwide distribution."
The MAA for Decapeptyl(R) 6 month formulation is supported by data from a phase III study on the efficacy and safety of two consecutive injections of triptorelin 6-month formulation in 120 patients with advanced prostate cancer. The results 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.
Triptorelin was licensed-in from Tulane University in 1982. Debiopharm developed and submitted a 1- and 3-month sustained release formulation of triptorelin pamoate in Europe and the U.S. The product is now marketed worldwide for the treatment of advanced prostate cancer, endometriosis, precocious puberty, in-vitro fertilisation programs, and uterine fibroids. Current licensee sales are in excess of US $400M.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. It 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 $2.65 billion in 2007.
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|SOURCE Debiopharm Group|
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