The company also plans to launch the drug in Germany and Portugal in due time. Decapeptyl LP 22.5mg is available as 1-3 months sustained release formulations and also daily formulation. Decapeptyl releases hormone (GnRH) agonist analogue over a period of time. The company had licensed marketing rights of the drug in territories where Ipsen commercializes triptorelin.
It is also marketed worldwide for the treatment of advanced prostate cancer, endometriosis, uterine fibroids, precocious puberty and female infertility, as part of in-vitro fertilisation programs. The companies received the marketing authorization for drug on November 10, 2009, in France, for treatment of locally advance prostrate cancer.
As reported, the companies completed the decentralised registration procedure in Europe for marketing, as national line extensions to the existing Decapeptyl's ones. The marketing for the drug was based on the phase III study involving nine countries in Europe.
Study results demonstrated the efficacy, pharmacokinetics and safety of two consecutive injections of triptorelin six- month-formulation in 120 patients with advanced prostate cancer. The overall data showed that the treatment was well tolerated. Debiopharm will manufacture Decapeptyl in its Debio RP facility in Switzerland.