Bayer, Onyx submit sorafenib MAA

Onyx (ONXX) said partner Bayer (FSE:BAYG; BAY) submitted an MAA to EMEA for sorafenib ( BAY 43-9006) to treat advanced renal cell carcinoma (RCC). In July, the companies completed submission of a rolling NDA to FDA for the same indication. The small molecule inhibitor of Raf kinase and VEGF receptor has Orphan Drug designation for RCC in the U.S. and EU, and Fast Track designation for metastatic RCC in the U.S. The companies hope to launch the product in the U.S. in the first half of 2006. ...