Navigation Links
Debiopharm Moves Towards a New 6-Month Formulation of Decapeptyl(R) to Further Help Prostate Cancer Patients

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.

About Decapeptyl(R)

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.

For more information on Debiopharm Group, please visit:

Debiopharm S.A. Contacts:

Jo-Anne Lutjens

Communications Manager

Tel: +41(0)79-370-27-15

Fax: +41(0)21-321-01-69

Maurice Wagner

Communications Director

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

Wendy Lau

Tel: +1-212-845-4272

Fax: +1-212-845-4260

SOURCE Debiopharm Group
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Debiopharm and EPFL Sign Research Project Agreement to Identify Inhibitors of Signalling Pathways Controlling Cell Fate for Cancer Treatment
2. Arriva Pharmaceuticals Moves Forward to Phase 2b Development of Lead Inhaled Protein rAAT Replacement Therapy for Hereditary Emphysema
3. Trellis(R) Catheter Removes Blood Clots Quickly, Restoring Blood Flow in 771 Deep Vein Thrombosis (DVT) Patients
4. Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market
5. Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials
6. CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI
7. Clinical Update - Decapeptyl(R)/Trelstar(R) 6-Month Formulation in Advanced Prostate Cancer
8. New Trial Presented at AAAAI Reports that the Growth of Children 2-5 Years Old with Year-Round Allergic Rhinitis Continued According to Normal Age-Adjusted Distribution Over a 6-Month Treatment with Nasacort AQ
9. ISTA Pharmaceuticals Presents Results from Two Phase III Clinical Trials of Xibrom(TM) QD (Once-daily) Formulation at the American Academy of Ophthalmology Annual Meeting
10. Kibow Biotech Obtains Australian, Chinese and Indian Patents Protecting the Composition and Basic Technology Behind Its Oral Probiotic Formulation for Chronic Kidney Failure
11. ISTA Pharmaceuticals Announces Results of Clinical Trial of Xibrom(TM) QD (Once-Daily) Formulation
Post Your Comments:
(Date:11/26/2015)... 26, 2015 --> ... SyMRI to find optimal contrast weighting of MRI for ... has signed a research agreement with SyntheticMR in order to ... SyMRI, it is possible to generate multiple contrast images from ... patient has left, thus making it possible to both fine ...
(Date:11/26/2015)... 26, 2015 ... of the  "2016 Future Horizons and ... Surface Testing Market: Supplier Shares, Competitive ... offering.  --> ) ... "2016 Future Horizons and Growth Strategies ...
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... November 28, 2015 , ... Safe storage for contraceptive ... two inventors, one from Lakewood, New Jersey and the other from Bradley Beach, New ... PROTECTOR to save the expense of having to replace NuvaRings more often than necessary. ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article published November ... meeting in Washington D.C. revolved around the fact that proper dental care, both at-home ... stressed the link between periodontal disease (more commonly referred to as gum disease) and ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from Hopkinsville, Ky., ... medications at home, so he invented the patent-pending ELECTRONIC M.D. , The ELECTRONIC ... In doing so, it could help to prevent potential overdose situations. As a ...
(Date:11/27/2015)... ... , ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over 50% of ... than 3.7 billion people under the age of 50 – or 67% of the population ... global estimates of HSV-1 infection . , "The data shocks us highly!" said Michelle ...
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping in ... for mental health and wellness consultation, has collaborated with a leading web-based marketplace ... knowledge gap experienced by parents and bring advice from parenting experts within their ...
Breaking Medicine News(10 mins):