News

GP Pharm files LUTRATE DEPOT® 1 month for registration in 5 European countries
09-11-2009

·        It is the first decentralized procedure the Spanish Biotech company files in Europe.

·        LUTRATE DEPOT® 1 month shows efficacy in hormone-dependent prostate cancer.

The Spanish biotech company GP Pharm, pioneering developing controlled release systems for injection has filed Lutrate Depot® 1 month (Leuprolide acetate 3.75mg) dossier for marketing in Spain, Portugal, Italy, Greece and Germany. It is the first decentralized procedure filed by GP Pharm.

Lutrate Depot® 1 month is the first controlled release drug completely developed by the Spanish biotech company. Lutrate Depot® 1 month is indicated for the treatment of advance prostate cancer, one of the most frequent in male population. Currently the biotech company has 2, 3 and 6 months formulations at advanced development stage.

GP Pharm expects to grant the authorization from health authorities mid next year and once obtained the approval the company expects launch the product in all 5 countries.

In parallel the company expects to file the dossier in the USA beginning 2010, though FAD as well as other European and international health agencies (Turkey, China, Japan)

Lutrate Depot® 1 month has been approved in some Latin-American countries during 2009 and launch started last quarter 2009.

Currently GP Pharm has 11 formulations under development, mainly within the framework of therapeutic areas for oncology (prostate cancer, ovarian cancer, breast cancer, carcinoid syndrome), central nervous system and cardiovascular diseases.