Ipsen, Debiopharm Complete European Decentralised Procedure For Decapeptyl

Debiopharm Group (Debiopharm) and Ipsen have reported that the 6-month sustained-release formulation of Decapeptyl (triptorelin embonate 22.5mg) has 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 22.5mg 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.

Reportedly, 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.

Jean-Luc Belingard, chairman and CEO at Ipsen, said: “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. The completion of this procedure represents a major step forward in the development of our uro-oncology franchise.”

Rolland-Yves Mauvernay, president and founder of Debiopharm, said: “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. 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.”