Yondelis(R) Receives Five New Approvals Outside the European Economic Area
Centocor Ortho Biotech Products has informed PharmaMar SA that the regulatory authorities in Israel, Panama and Ukraine have approved Yondelis(R) for advanced soft tissue sarcoma (STS) in adults. Furthermore, the authorities in Paraguay and Azerbaijan have approved the drug for platinum-sensitive recurrent ovarian cancer (ROC). Yondelis is already approved for STS in Paraguay and Azerbaijan.
The European Commission approved Yondelis(R) for platinum-sensitive ROC in September 2009. Outside the European Economic Area (EEA), Yondelis(R) has now been approved for platinum-sensitive ROC in Azerbaijan and Paraguay; it had already been approved in Kazakhstan and the Philippines.
In view of the three new approvals for STS, Yondelis(R) 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.
Clinical trials are under way to expand the use of Yondelis(R) in sarcoma, including a trial as first-line treatment in patients with translocation-associated tumors, in children with Ewing sarcoma, rhabdomyosarcoma and other forms of STS. Yondelis(R) is also undergoing trials in solid tumors, such as prostate, breast and lung cancer.
Yondelis(R) has orphan drug status for soft tissue sarcoma and ovarian cancer in the European Union, the United States, Switzerland, and for soft tissue sarcoma in South Korea.
According to the licensing agreement between PharmaMar (Zeltia, S.A. subsidiary) and Centocor Ortho Biotech Products, L.P., PharmaMar has the rights to sell Yondelis(R) in Europe (including Eastern Europe), while Centocor Ortho Biotech Products, L.P. has the rights to sell the drug everywhere else, except in Japan, where Taiho Pharmaceutical Co., Ltd. has a licensing agreement for the development and sale of Yondelis(R).