Navigation Links
Debiopharm Moves Towards a New 6-Month Formulation of Decapeptyl(R) to Further Help Prostate Cancer Patients
Date:9/25/2008

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: http://www.debiopharm.com.

Debiopharm S.A. Contacts:

Jo-Anne Lutjens

Communications Manager

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

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

jalutjens@debiopharm.com

Maurice Wagner

Communications Director

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

Wendy Lau

Tel: +1-212-845-4272

Fax: +1-212-845-4260

wendy.lau@russopartnersllc.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/19/2017)... 19, 2017  nThrive™, an independent Patient-to-Payment? solutions ... thought leadership at the 2017 HIMSS Conference. The ... award from KLAS. nThrive will host ... how market trends shape the holistic, integrated revenue ... comprehensive Patient Access solution. The panel will reveal ...
(Date:2/18/2017)... Feb. 17, 2017 Research and Markets has announced ... report to their offering. ... The report provides separate comprehensive analytics for the US, Canada ... Asia-Pacific , Latin America , and ... 2015 through 2022. Also, a six-year historic analysis is provided for these ...
(Date:2/17/2017)... PUNE, India , February 17, 2017 ... Product (Airborne Particle Counters, Liquid Particle Counters), Application (Cleanroom Monitoring, Contamination ... Global Forecast to 2021" published by MarketsandMarkets, the market is expected ... in 2016, at a CAGR of 3.7% from 2016 to 2021. ... ...
Breaking Medicine Technology:
(Date:2/17/2017)... Austin, Tx (PRWEB) , ... February 17, 2017 ... ... of revenue cycle management services, announced today that Karen Pilley has been promoted ... expenses is critical in today’s shifting healthcare paradigm – a shift that demands ...
(Date:2/17/2017)... ... February 17, 2017 , ... PrideStaff, a national staffing ... named to Staffing Industry Analysts' 2017 "Staffing 100 North America" list. , ... notable contributions to the staffing industry over the last twelve months. Industry insiders ...
(Date:2/17/2017)... ... ... Like most hospitals across the nation, Onslow Memorial Hospital is looking for ... Reduction Program (HRRP), the return of a patient to the hospital within 30 days ... many providers are struggling to leverage limited resources and technology, Onslow Memorial Hospital has ...
(Date:2/17/2017)... ... February 17, 2017 , ... The ... assistance to families and business owners in and around the Hampton Roads metropolitan ... help prevent all forms of domestic violence. , There are multiple categories of ...
(Date:2/16/2017)... ... February 17, 2017 , ... ... over 10 years of research, development and clinical trials, the founder of Chigurupati ... a patented compound of FDA approved ingredients that when infused into alcohol, protect ...
Breaking Medicine News(10 mins):