Debiopharm and its European licensee, Ipsen, confirmed French regulatory clearance for the six-monthly sustained-release formulation of the LHRH agonist, Decapeptyl®, for locally advanced and metastatic prostate cancer. Ipsen says that it expects to launch the drug in France during the first quarter of 2010.
The six-monthly formulation was approved in October via the European decentralized registration procedure in nine countries: Germany (the reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain, and The Netherlands. Regulatory submissions in Portugal, the U.K., Ireland, Italy, Romania, and Lithuania have been filed as national line extensions to existing approvals for other Decapeptyl formulations.
The therapy is already available in monthly and quarterly sustained-release formulations as well as a daily formulation. It is sanctioned in various markets including the U.S. for the treatment of advanced prostate cancer as well as for indications in endometriosis, precocious puberty, IVF, and uterine fibroids. Debiopharm says worldwide sales by its licensees are over $400 million.