PharmaMar/Centocor's Yondelis gets five new approvals outside the European Economic Area

Centocor Ortho Biotech Products, a Johnson & Johnson subsidiary that has licensed rights in certain markets for Yondelis (trabectedin) from PharmaMar, part of Spain's Grupo Zeltia, says that the regulatory authorities in Israel, Panama and Ukraine have approved the drug for advanced soft tissue sarcoma (STS) in adults. Furthermore, the authorities in Paraguay and Azerbaijan have cleared the drug for platinum-sensitive recurrent ovarian cancer (ROC). Yondelis is already approved for STS in Paraguay and Azerbaijan.

Zeltia recently reported 2009 sales of (123.4 million euros ($169.8 million) in 2009, up 17.2% on 2008, with Biopharmaceutical revenues expanded 53.3% due primarily to sales of Yondelis, which totaled 44.12 million euros last year. In November, the European Commission authorized the marketing of Yondelis for ovarian cancer, after which sales commenced in some European countries.

In view of the three new approvals for STS, Yondelis now has authorization for this indication in 25 countries outside the EEA: Argentina, Azerbaijan, Bolivia, Chile, Colombia, Curacao, Hong Kong, India, Israel, Kazakhstan, Macao, Malaysia, Mexico, Panama, Paraguay, the Philippines, Russia, Singapore, South Korea, Switzerland, Thailand, Ukraine, Uruguay, Venezuela and Vietnam. PharmaMar has already begun collecting royalties from sales in the aforementioned countries.