Swissmedic grants PharmaMar

Spanish drugmaker PharmaMar's Yondelis (trabectedin) has been granted orphan drug status by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with soft tissue sarcoma and ovarian cancer. The European Commission and the US Food and Drug Administration granted OD status to the agent in STS in 2001 and 2004 and in ovarian cancer in 2003 and in 2005, respectively. An application for marketing authorization for Yondelis in the treatment of ovarian cancer is expected to be submitted to the European regulator during 2008. Approval in STS is expected in Switzerland in the fourth quarter. The agent is currently being developed by PharmaMar in partnership with US health care major Johnson & Johnson. According to their licensing agreement, PharmaMar will market Yondelis in Europe while J&J units Ortho Biotech will market it in the USA, and Janssen-Cilag in the rest of the world.