Ipsen launches Decapeptyl LP 22.5 mg in France

Feb 4 2010

Ipsen (Euronext: FR0010259150; IPN), an innovation-driven global specialty pharmaceutical group and 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, announce the launch by Ipsen in France of Decapeptyl(R) LP 22.5 mg 6-month sustained-release formulation for the treatment of locally advanced or metastatic hormone-dependent prostate cancer. Other launches are planned shortly, notably in Germany and Portugal.

The marketing authorisation (MA) to this 6-month sustained-release formulation of Decapeptyl(R) (triptorelin embonate[1] 22.5 mg) was granted on 10 November 2009 by the French regulatory authorities (Agence Francaise de Securite Sanitaire des Produits de Sante, AFSSAPS) for the treatment of locally advanced and metastatic hormone-dependent prostate cancer. France was the first country to approve Decapeptyl(R) LP 22.5 mg in the context of a Decentralised Procedure in Europe. The reimbursement rate by Social Security and price setting decision have been published in the Journal Officiel of 3 February 2010, i.e. less than three months after MA was granted.

Decapeptyl(R) LP 22.5 mg is the new sustained-release 6-month formulation of a gonatropin- releasing hormone (GnRH) agonist analogue developed by Debiopharm Group. Debiopharm has licensed the marketing rights to Ipsen for all territories where Ipsen currently commercialises triptorelin.

On 13 October 2009, Ipsen and Debiopharm Group announced the successful completion of the European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands while for other European countries (Portugal, United Kingdom, Ireland, Italy, Romania and Lithuania), the marketing authorisation applications were filed as national line extensions to the existing Decapeptyl(R)'s ones.