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The Spanish Agency for Medicines and Health Products (AEMPS) has issued a positive final assessment for GP Pharm’s Lutrate Depot ® 1 month (Leuprolide acetate 3.75 mg), a hormone treatment to prevent tumor growth in patients with advanced prostate cancer.

This new drug incorporates micro-nano technology for sustained-release encapsulation that achieves the same efficacy with lower doses of active ingredient and, therefore, reduces possible side effects for the patient.

Lutrate Depot ® 1 month has been authorized through a decentralized procedure that, in this first stage, included participation from the national agencies of Germany, Italy, Greece and Portugal, in addition to the AEMPS. The second phase will begin shortly for approval in 16 other European Union countries

Lutrate Depot ® 1 month is the first drug developed entirely by GP Pharm using their micro-nano encapsulation platform.

In EU countries, authorization to market a drug must follow established protocols. A decentralized or mutually recognized registration process is carried out when an authorization request simultaneously affects two or more member states. In this case, evaluation is carried out by one state —through the AEMPS— and the others recognize its evaluation.

The new treatment is already marketed in Peru, Uruguay and Chile and authorization is pending in Argentina, Turkey and Mexico. The company will soon submit registration dossiers in the United States, China, Russia and Canada.

Approval of Lutrate Depot ® 1 month is the culmination of the first drug developed entirely by GP Pharm, from the initial stages of drug research through to its launch to the pharmaceutical market, making it one of the few Spanish biotechnology firms to launch its own product. “With this product, we are validating our business model and consolidating our growth potential in a market that represents more than €1,000 millions worldwide,” explains Alberto Bueno, CEO of GP Pharm.

Prostate cancer is the third most common tumor in men, after lung and colon, and is currently the second leading cause of cancer death in men. Ninety percent of all cases occur in men over 65.

This Catalan biotech firm has already initiated Phase III clinical trials on Lutrate Depot ® 3 month in the United States.

GP Pharm’s new drug is also available in three- and six-month formulas. Lutrate Depot ® 3 month, which allows for a single dose once every three months, is currently undergoing Phase III clinical trials in the United States. This is a multicenter study designed to evaluate the efficacy and safety of this new formula, with 160 prostate-cancer patients from 33 specialized care centers in the United States, who will be treated over six months. Furthermore, the new Lutrate Depot ® 6 month is in the pre-clinical phase and is expected to move into clinical trials in early 2012.

Based in Gavà (Barcelona), GP Pharm uses a business model that combines research and development activity based on patented technology platforms (liposomes and microspheres) with activity to market and manufacture their own injectable products for oncology, cardiovascular and central nervous system treatments.

Founded in 2000, this Catalan biopharmaceutical company has a high-tech manufacturing plant in Sant Quintí de Mediona, 60 kilometers from Barcelona. The plant develops and manufactures the company’s own products for international consumption. It is the only plant for oncological injectables in Spain, and the only one in Europe to produce injectable liposomal forms to treat different types of cancer and that is able to produce microspheres in sterile conditions.

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