Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc’s. (Nasdaq:ONXX) Nexavar® (sorafenib) tablets has been granted Orphan Medicinal Product (OMP) status for the treatment of hepatocellular carcinoma (HCC), or liver cancer, by the European Commission.
"This orphan medicinal product designation demonstrates the European Commission's commitment to the study and development of treatments for rare diseases," said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation. "This support adds momentum to our research efforts with Nexavar and brings hope of a new treatment option to liver cancer patients in
Europe ."
The positive results of the Phase II single agent study of Nexavar® was reported at the 16th American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AACR-NCI-EORTC) meeting in 2004 while a Phase II single agent trial is on-going.
Nexavar® has been granted UFDA approval in December 2005 for the treatment of advanced renal cell carcinoma (RCC), or kidney cancer while the European Commission has given it an orphan medicinal product designation for kidney cancer. In September 2005, a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) for approval to market Nexavar® within the European Union for kidney cancer.
Source: PR Newswire
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