GP Pharm Files Lutrate Depot® One Month for Registration in Five European Countries
The Spanish biotech company GP Pharm, which pioneers and develops controlled release systems for injection, has filed the Lutrate Depot® 1 month (Leuprolide acetate 3.75mg) dossier for marketing in Spain, Portugal, Italy, Greece and Germany. It is the first decentralised 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 cancers in men. Currently the biotech company has two, three and six-month formulations at an advanced development stage.
GP Pharm expects to receive authorisation from health authorities in mid-2010, and once obtained the approval the company expects to launch the product in all five countries.
Also, the company expects to file the dossier in the US at the beginning of 2010, through the FDA, as well as other European and international health agencies (including in Turkey, China and Japan).
Lutrate Depot 1 month has been approved in some Latin-American countries during 2009 and it was launched in the last quarter of 2009.
Currently GP Pharm has eleven formulations under development, mainly within the framework of therapeutic areas for oncology (prostate cancer, ovarian cancer, breast cancer and carcinoid syndrome), the central nervous system and cardiovascular diseases.