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, and Ipsen (Euronext: FR0010259150; IPN), an innovation-driven global specialty pharmaceutical Group, announced that the 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate 22.5 mg) successfully completed its European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands.
Triptorelin embonate 22.5 mg is Debiopharm’s new 6-month-formulation of a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer. Debiopharm has licensed the European marketing rights to Ipsen. The first European countries to launch the 6-month formulation should be Germany, The Netherlands and Spain.
“As expected, we are proud to offer patients suffering from prostate cancer a new 6-month formulation of Decapeptyl® with an improved convenience and a consistent and similar efficacy to the already established 1 and 3-month formulations,” said Jean-Luc Bélingard, Ipsen’s Chairman and Chief Executive Officer. “The completion of this procedure represents a major step forward in the development of our uro-oncology franchise.”
“It is great news that the completion of the European decentralised procedure for triptorelin embonate 6-month formulation was done in such a timely manner,” added Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. “We view this achievement as further evidence of the efficacy and safety of this important product. LHRH-agonists will remain the mainstay of hormone-dependent prostate cancer in the years ahead, and patients can now look forward to receiving a more convenient treatment every six months instead of every three months.”