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Sorafenib NDA Submitted for Review to FDA

WEST HAVEN, Conn. and EMERYVILLE, Calif., July 11 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that the companies have completed the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for sorafenib (BAY 43-9006) for patients with advanced renal cell carcinoma (RCC), or kidney cancer.

"New treatment options are clearly needed for people with advanced kidney cancer," said Wolfgang Plischke, President of Bayer HealthCare's Global Pharmaceutical Division. "We were encouraged by our Phase III results, as we are now with the completion of the NDA filing. Pending the FDA's acceptance and favorable review of our filing, we expect to launch sorafenib in the first half of 2006."

Sorafenib was accepted by the FDA into the Pilot 1 Program for continuous marketing applications. The Pilot 1 Program was designed for therapies that have been granted Fast Track status and have the potential to provide important therapeutic benefit over available therapies. Under the Pilot 1 Program designation, the FDA is committed to reviewing each "reviewable unit" of the submission within a six month timeframe.

The sorafenib submission is based on an ongoing Phase III trial in patients with advanced kidney cancer. Results from the study - the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer - were presented in May at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).

Sorafenib is currently available to patients throughout the United States through a treatment protocol known as the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) study. To be eligible, individuals with advanced kidney cancer may not have been previously treated with sorafenib. Physicians who are interested in becoming investigators should call 1-866-639-2827. Interested patients should discuss this with their doctor or call the number above. A similar trial will start in Europe shortly, and Bayer and Onyx are in discussions with regulators about similar programs in other territories.

Phase III Results Presented at ASCO: Progression-free Survival Doubled
At ASCO, investigators reported that sorafenib doubled progression-free survival (PFS) when compared to those patients who received placebo. As assessed by independent radiologic review, PFS was doubled to a median value of 24 weeks in patients receiving sorafenib as compared to 12 weeks for patients receiving placebo (p-value The pivotal trial was initiated in the fourth quarter of 2003 after a Special Protocol Assessment (SPA) was completed by the FDA. Previously, the companies announced that patients enrolled in the Phase III kidney cancer trial who were receiving placebo could "cross over" to drug treatment based on the clinical and statistical significance of the PFS data. The study is ongoing, and patients will continue to be treated and followed for survival.

Thus far, 769 patients have been evaluated for safety. Drug-related adverse events (all grades) were similar to what has been observed in previous clinical trials and included: rash, diarrhea, hand foot syndrome, hair loss, itching, nausea, hypertension, and fatigue.

About Sorafenib
Sorafenib, a novel investigational drug candidate, is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In preclinical models, sorafenib targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-b, KIT, FLT-3 and RET.

Source: Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.

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