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

LAUSANNE, Switzerland, July 21 /PRNewswire/ -- Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, today announced that the Swiss agency for therapeutic products, Swissmedic, has issued a marketing authorisation for Moapar(R) 11.25mg, the first 3-month injectable formulation, prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering from sexual deviations. Developed by Debiopharm, Moapar(R) contains a gonadotropin-releasing hormone (GnRH) agonist analogue.

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

Debiopharm already received marketing authorisations and signed license agreements for the distribution of Salvacyl(R)/Moapar(R) in nine major European countries, including France, Germany, the United Kingdom, Sweden, Norway, Denmark, Belgium, the Netherlands and Finland. The product was launched earlier this year in Germany and Belgium. Initial contacts with potential distribution partners for the Swiss market have been made.

About Moapar(R)

In the treatment of sexual deviations in men, intra-muscular administration of Moapar(R) every 3 months, in combination with psychotherapy, presents an advantage over daily oral forms or intra-muscular weekly 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 with psychotherapy, regular injections of the active ingredient, triptorelin, over a period of eight months to seven years in male patients with sexual deviations demonstrated a good efficacy and safety profile. Triptorelin decreased serum testosterone to the level of castration in all patients. Concurrent with the decrease in testosterone levels, the treatment reduced deviant sexual behaviours in 35 of 36 patients with severe sexual deviations. In men who interrupted treatment, testosterone levels progressively returned to normal.

About Debiopharm Group

Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed 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 four products with global combined sales in excess of US$2.6 billion in 2008.

For more information on Debiopharm Group, please visit:

    Debiopharm S.A. Contact:

    Maurice Wagner
    Director Corporate Affairs & Communication
    Tel.: +41(0)21-321-01-11
    Fax: +41(0)21-321-01-69

    Additional Media Contacts:

    In London:
    Brian Hudspith
    Tel: +44(0)20-7379-5151

    In New York:
    Russo Partners, LLC
    Martina Schwarzkopf, Ph.D.
    Account Executive
    Tel: +1-212-845-4292
    Fax: +1-212-845-4260

SOURCE Debiopharm Group
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
2. Rendell Administration Announces Health Research Grants From Tobacco Settlement Funds
3. FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
4. Susan G. Komen for the Cure(R) Makes Unprecedented Research and Local Program Grants
5. KGI Professor Ian Phillips Awarded Defense Grants for Medical Combat Research
6. Immigrants From India, Pakistan Face U.S. Prostate, Breast Cancer Risks
7. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
8. FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - A Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronary Arteries
9. FDA Grants NeoVistas Request to Expand CABERNET Trial to 30 Sites in the U.S.
10. FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
11. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
Post Your Comments:
(Date:11/25/2015)... THOUSAND OAKS, Calif. , Nov. 25, 2015 /PRNewswire/ ... of a Biologics License Application (BLA) with ... Administration (FDA) for ABP 501, a biosimilar candidate to ... the first adalimumab biosimilar application submitted to the FDA ... biosimilar pathway. Sean E. Harper , M.D., ...
(Date:11/25/2015)... On Tuesday, November 24, 2015, the ... Wright Medical Technology, Inc. for product liability and ... implant device, awarded $11 million in favor of ... and three days of deliberations, the jury found ... designed and unreasonably dangerous, and that Wright Medical ...
(Date:11/25/2015)... -- Allergan plc (NYSE: AGN ) today announced that ... York State Attorney General,s Office to end the ... statutes with the Attorney General over the decision of Forest ... selling the now generic version of memantine immediate release tablets.  ... released its counterclaims against New York , ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article ... the way that they are handling security in light of the recent terrorist attacks ... in an attempt to stop an attack from reaching U.S. soil. Especially around special ...
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss ... to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy followed ...
(Date:11/27/2015)... ... November 27, 2015 , ... "When ... said an inventor from Hillside, N.J. "Many people catch diseases simply from sitting ... individuals will always be protected from germs." , He developed the patent-pending QUDRATECS ...
(Date:11/27/2015)... ... ... The print component of “Supporting Our Caregivers” is distributed ... Minneapolis, South Florida, with a circulation of approximately 250,000 copies and an estimated ... media strategy and across a network of top news sites and partner media ...
(Date:11/27/2015)... ... ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over 50% of its ... 3.7 billion people under the age of 50 – or 67% of the population - ... estimates of HSV-1 infection . , "The data shocks us highly!" said Michelle Li, ...
Breaking Medicine News(10 mins):