European Union Grants Orphan Drug Status to Mesothelioma Drug

Italian pharmaceutical research and manufacturing company MolMed S.p.A. has announced that the Committee for Orphan Medicinal Products of the European Medicines Agency of the European Union has granted an “orphan drug” designation to Arenegyr, MolMed’s anti-tumor agent, when used in the treatment of malignant pleural mesothelioma. Effective mesothelioma treatments are scarce on the ground, both because the disease is so very difficult to treat pharmaceutically, and because mesothelioma, while devastating, affects relatively few patients. The European Union grants the orphan drug designation to life-threatening or chronically debilitating diseases that do not affect more than 5 in 10,000 people. An orphan drug designation confers a number of benefits on the drug’s maker, in order to encourage researchers to develop drugs for these rare conditions. Orphan drug applicants have reduced time to market for regulatory oversight, receive assistance from the European Medicines Agency in the drug development process, pay reduced fees to regulatory agencies, and are granted a special ten-year period to market the drug without competition.

Arenegyr is a drug which targets the blood supply of tumors, in combination with a powerful cancer-fighting substance called a cytokine. The drug binds itself to cells in the tumor’s blood vessels, and the anti-cancer agent then destroys nearby cancerous cells. Arenegyr has had promising results in clinical trials and research into the drug is ongoing, giving new hope to many mesothelioma patients. Recent trials indicate the drug has substantial clinical benefit, increasing survival times for mesothelioma sufferers. More results are expected by the end of 2008.