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:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
(Date:6/23/2016)... 23, 2016  In a startling report released today, National ... by lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... of how states are tackling the worst drug crisis in recorded ... – Kentucky , New Mexico ... . Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. ... articles published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Grove Investment Group (TGIG), has initiated cultivation and processing operations at its production ... and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of ...
(Date:6/24/2016)... ... ... recruitment firm Slone Partners is pleased to announce the placement of Suzanne ... of North American Capital Sales at HTG Molecular . , In ... commercialization of the HTG EdgeSeq system and associated reagents in North America. , Headquartered ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... induced pluripotent stem (iPS) cells and other difficult to transfect cells, announces its ... The PluriQ™ G9™ Gene Editing System is a complete system for ...
Breaking Medicine News(10 mins):