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Clinical Update - Decapeptyl(R)/Trelstar(R) 6-Month Formulation in Advanced Prostate Cancer
Date:2/12/2008

- Presentation of Efficacy and Safety Phase III Results -

LAUSANNE, Switzerland, Feb. 12 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist focusing on serious medical conditions and particularly oncology, presented today at the 9th International Symposium on GnRH in Berlin, Germany, the results of a phase III study with its new 6-month formulation of Decapeptyl(R)/Trelstar(R) (triptorelin), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of advanced prostate cancer. These results show similar efficacy and safety to the already marketed 1- and 3-month formulations.

This multicenter, open, non-comparative, phase III study on the efficacy and safety of two consecutive injections of triptorelin 6-month formulation in 120 patients with advanced prostate cancer, 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 < or equal to 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. Furthermore the adverse event profile of the new 6-month formulation of triptorelin is fully comparable to that observed with the 1- and 3-month formulations.

"Our 1- and 3-month formulations of Decapeptyl(R) and Trelstar(R) are used worldwide in the treatment of prostate cancer. However they require one injection every 4 or 12 weeks respectively. The 6-month formulation will improve patient compliance and increase convenience and comfort with the need of only one intramuscular injection every 24 weeks," said Kamel Besseghir, CEO of Debiopharm S.A.

About Decapeptyl(R)/Trelstar(R)

Triptorelin was licensed-in from Tulane University in 1982. Debiopharm developed and submitted a 1- a
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SOURCE Debiopharm Group
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