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Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations

Friday, September 18, 2009 General News J E 4
LAUSANNE, Switzerland, July 21 Debiopharm Group(Debiopharm), a Swiss-based global biopharmaceutical group of companies witha focus on the development of prescription drugs that target unmet medicalneeds, today announced that the Swiss agency for therapeutic products,Swissmedic, has issued a marketing authorisation for Moapar(R) 11.25mg, thefirst 3-month injectable formulation, prescribed for a reversible reductionof serum testosterone to the level of castration in adult men suffering fromsexual deviations. Developed by Debiopharm, Moapar(R) contains agonadotropin-releasing hormone (GnRH) agonist analogue.

"We are very pleased that Swissmedic has recognised the potential oftreatment of sexual deviations with Moapar(R)," said Rolland-Yves Mauvernay,President and Founder of Debiopharm Group. "This is an important signal forus, as we move closer to providing an alternative treatment for thiscontroversial disorder. It's a small market, but we feel that it's our dutyto make this treatment available to the medical profession."

Debiopharm already received marketing authorisations and signed licenseagreements for the distribution of Salvacyl(R)/Moapar(R) in nine majorEuropean countries, including France, Germany, the United Kingdom, Sweden,Norway, Denmark, Belgium, the Netherlands and Finland. The product waslaunched earlier this year in Germany and Belgium. Initial contacts withpotential distribution partners for the Swiss market have been made.

About Moapar(R)

In the treatment of sexual deviations in men, intra-muscularadministration of Moapar(R) every 3 months, in combination withpsychotherapy, presents an advantage over daily oral forms or intra-muscularweekly injections required with antiandrogens such as cyproterone acetate(CPA) and medroxyprogesterone acetate (MPA), and there are fewer side effects.

The approval is based on two studies showing that, combined withpsychotherapy, regular injections of the active ingredient, triptorelin, overa period of eight months to seven years in male patients with sexualdeviations demonstrated a good efficacy and safety profile. Triptorelindecreased serum testosterone to the level of castration in all patients.Concurrent with the decrease in testosterone levels, the treatment reduceddeviant sexual behaviours in 35 of 36 patients with severe sexual deviations.In men who interrupted treatment, testosterone levels progressively returnedto normal.

About Debiopharm Group

Debiopharm Group is a Swiss-based global biopharmaceutical group ofcompanies with a focus on the development of prescription drugs that targetunmet medical needs. It develops its products for global registration andmaximum commercial potential. Once registered, the products are out-licensedto pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of itsproducts 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, Debiopharmhas developed four products with global combined sales in excess of US$2.6billion in 2008.

For more information on Debiopharm Group, please visit:http://www.debiopharm.com.Debiopharm S.A. Contact: Maurice Wagner Director Corporate Affairs & Communication Tel.: +41(0)21-321-01-11 Fax: +41(0)21-321-01-69 mwagner@debiopharm.com Additional Media Contacts: In London: Maitland Brian Hudspith Tel: +44(0)20-7379-5151 bhudspith@maitland.co.uk In New York: Russo Partners, LLC Martina Schwarzkopf, Ph.D. Account Executive Tel: +1-212-845-4292 Fax: +1-212-845-4260 martina.schwarzkopf@russopartnersllc.com

SOURCE Debiopharm Group


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