The marketing authorisation (MA) to this 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate (1) 22.5 mg) was granted on 10 November 2009 by the French regulatory authorities (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) for the treatment of locally advanced and metastatic hormone-dependent prostate cancer. France was the first country to approve Decapeptyl® 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® 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®’s ones. About Decapeptyl® Debiopharm licensed-in triptorelin from Tulane University in 1982. Decapeptyl® is available in 1- and 3-month sustained-release formulations, as well as a daily formulation. Debiopharm developed and registered the 1- and 3-month sustained release formulations of triptorelin embonate in Europe and the U.S. The active substance in Decapeptyl® is triptorelin, a decapeptide analogue of GnRH (Gonadotropin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotropins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testes and ovaries. Debiopharm will manufacture the 6-month formulation at Debio R.P., its FDA-inspected production facility in Switzerland. About Ipsen Ipsen is an innovation-driven global specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4’200. About Debiopharm Group Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses promising biological and small molecule drug candidates. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing. Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.