Navigation Links
Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
Date:7/21/2009

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: 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
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:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... LONDON , January 19, 2017 ... Grothey ; European Oncology & Haematology, 2016;12(Suppl 2):3-8; ... ... http://photos.prnewswire.com/prnh/20151014/276718LOGO) Published recently in ... the peer-reviewed journal from touchONCOLOGY, an article by ...
(Date:1/19/2017)... , Jan. 19, 2017 ViewRay, Inc. ... a federal institution supporting research in Germany ... and patient treatments at the University Clinic Heidelberg as ... The MRIdian Linac program will be headed by ... also heads radiation oncology at the German Cancer Research ...
(Date:1/19/2017)... Calif. , Jan. 19, 2017   Science ... is excited to announce that the first five ... Biology  (RP:CB) have been published in eLife today. ... project represents the first practical evaluation of reproducibility ... in reproducible studies. Unlike other assessments of reproducibility, ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... Source Vitál Apothecary, a skin and ... essential oils, announced the company had a successful visit to the 2017 ECRM Diet, ... gives companies that work in the nutritional, sports and health industries a chance to ...
(Date:1/20/2017)... FL (PRWEB) , ... January 20, 2017 , ... International ... of nutritional and bodybuilding supplements, announced it attended the January ECRM trade show in ... bodybuilder and nutritional scientist who was determined to create a line of products that ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Angel”: a heartwarming and earnest tale ... each of his children. “The Angel” is the creation of published author, Marjorie Lund-Fontaine, ... City, and impassioned writer. , When asked of her new book, Marjorie says, “‘The ...
(Date:1/20/2017)... ... ... to Christmas:” a beautiful and enchanting tale that teaches children the true meaning of Christmas. ... in Oklahoma City, and a devoted woman of faith. , “Becoming a parent changes ... back of my mind for years, but actually doing it might have been a while ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... E-learning system for Clinical and Regulatory education for Physicians, Physician Advisors, Case ... successful education methodology of Disease Specific Documentation Improvement. , The Aerolib Learning ...
Breaking Medicine News(10 mins):