Pharmacotherapy
FDA Accepts Sorafenib into Pilot 1 Program
By Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.
May 4, 2005 - 9:43:00 PM

Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that sorafenib (formerly BAY 43-9006) has been accepted into the U.S. Food and Drug Administration's (FDA) Pilot 1 Program for continuous marketing applications.

The Pilot 1 Program was designed for therapies that have been granted Fast Track status by the FDA and that have the potential to provide important therapeutic benefit over available therapy. Sorafenib was granted Fast Track status for metastatic renal cell carcinoma (RCC), or kidney cancer, in March 2004.

"Participating in the Pilot 1 Program offers Bayer and Onyx the opportunity to continue the productive dialogue that was established with the FDA at the beginning of this clinical program," said Wolfgang Plischke, Head of Bayer HealthCare's Pharmaceuticals Division. "We are preparing our New Drug Application (NDA) for submission in this indication and receiving Pilot 1 status facilitates the review process. Pending completion of the NDA filing, we hope to make this treatment available to patients in the first half of 2006 if approved by FDA."

As one of the Prescription Drug User Fee Act (PDUFA) goals, the Pilot 1 Program is intended to expedite the continuous marketing application (CMA) concept (known generally as a "Rolling NDA"). As part of the program, eligible applicants submit portions ("Reviewable Units") of an application before submitting the complete NDA. The FDA agrees to complete review of these sections within a specified period of time and to provide early feedback to the applicant. Under the Pilot 1 Program designation, the FDA is committed to completing the review of each of these sections on a six-month timeline.

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-beta, KIT, FLT-3 and RET.

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