LAUSANNE, Switzerland, June 20 /PRNewswire/ -- The Debiopharm Group (Debiopharm), a global independent biopharmaceutical development company specialising in oncology and serious medical conditions, announced that Moapar(R) 3 months was granted marketing approval (MA) by the Swedish national authorities for the reversible reduction of testosterone to castrate serum levels, in order to control sexual drive in adult men. Debiopharm will apply for wider European approval through the Mutual Recognition Procedure (MRP) and will be seeking a commercial partner for the sales and marketing of the product.
In the treatment of sexual deviations in men, administration of a drug 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).
Moapar(R) has shown fewer side-effects compared to antiandrogens (CPA and MPA), including a lower risk of hepatocellular damage, thromboembolism and gynecomastia. They show neither cardiovascular toxicity observed with diethylstilbestrol (DES) treatment, nor hepatic toxicity induced by antiandrogens like Flutamide. Moapar(R) has no other risks than those known to be related to hypogonadism.
Moapar(R), a gonadotropin releasing hormone (GnRH) analogue, is effective in the treatment of sexual deviations by inducing and maintaining castrate serum testosterone levels. Two studies have shown that monthly injections of triptorelin over a period of eight months to seven years, in young male patients with sexual deviations demonstrated a good safety and efficacy profile. In the first study, plasma testosterone levels in five out of six patients dropped to castrate levels, from normal at pre-treatment (22.9 plus or minus 2.8nmol/l) to 1.2 plus or minus 0.3 nmol/l. In the other, 30 patients were treated successfully and all demonstrated reduction in serum testosterone levels to castrate levels, from normal before therapy (18.9 plus or minus 6.8 nmol/l) to 0.9 plus or minus 0.5 nmol/l after six months.
About The Debiopharm Group
The Debiopharm Group is a global biopharmaceutical development company 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 $2.2 billion in 2005.
For more information on the Debiopharm Group, please visit: www.debiopharm.com.
The Debiopharm Group
CONTACT: Debiopharm Contacts: Kim Bill, VP Business Development & LegalAffairs, Debiopharm S.A., Tel.: +41-21-321-01-11, Fax: +41-21-321-01-69,kbill@debio.com. Additional Media Contacts: In London, Maitland NoonanRusso, Brian Hudspith, Tel: +44-(0)20-7379-5151, bhudspith@maitland.co.uk.In New York, Noonan Russo, A division of Euro RSCG Life PR, Wendy Lau,Senior Account Executive, Tel: +1-212-845-4272, Fax: +1-212-845-4260,wendy.lau1@eurorscg.com
