BAY 43-9006 Receives Fast Track Designation From the FDA for Metastatic Kidney Cancer Review

BAY 43-9006 Receives Fast Track Designation From the FDA for
Metastatic Kidney Cancer Review
Small Molecule Compound in Pivotal Phase III Study 


WEST HAVEN, Conn., and RICHMOND, Calif., April 5  /PRNewswire-FirstCall/ --
Bayer Pharmaceuticals Corporation  and Onyx Pharmaceuticals, Inc.  announced
today that BAY 43-9006 has been granted Fast Track status by the U.S. Food and
Drug Administration (FDA).  The compound is being evaluated for the treatment of
metastatic renal cell carcinoma, or advanced kidney cancer.  Currently in Phase
III clinical testing, BAY 43-9006 is a novel RAF kinase and VEGF inhibitor that
prevents tumor growth by combining two anticancer activities: inhibition of
tumor cell proliferation and tumor angiogenesis. Bay 43-9006 is being
co-developed by Bayer and Onyx.

The Fast Track program is designed to expedite the review of drug compounds for
the treatment of patients with serious or life-threatening diseases where there
is an unmet medical need for new therapeutic approaches. Having a Fast Track
designation allows a company to file a New Drug Application (NDA) on a rolling
basis as data becomes available.  This permits the FDA to review the filing as
it is received, rather than waiting for the entire document prior to commencing
the review process.  With a Fast Track designation, there may be more frequent
interactions with the FDA and there may be the possibility of a priority review,
which could decrease the typical review period.

"The recent FDAaction underscores the need for new therapeutic options for
people with metastatic renal cell carcinoma," said Susan Kelley, M.D., vice
president, Oncology, Bayer Pharmaceuticals Corporation." Bayer and Onyx are
engaged in a large pivotal Phase III study examining the efficacy and safety of
BAY 43-9006 in this patient population.  We look forward to compiling the data
generated from this trial and submitting it to the FDA."

In clinical trials, BAY 43-9006, a novel investigational drug candidate,
demonstrated both anti-proliferative and anti-angiogenic properties -- two
important anticancer activities.  In preclinical models, BAY 43-9006 inhibited
tumor cell proliferation by targeting the RAF/MEK/ERK signaling pathway at the
level of RAF kinase.  BAY 43-9006 also exerted an antiangiogenic effect by
targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated
signaling cascades.

Renal cell carcinoma is the most common form of kidney cancer.  Median survival
for patients with advanced metastatic kidney cancer is estimated at eight to 12
months. Approximately 32,000 people in the U.S. are diagnosed with kidney cancer
annually, and about 12,000 Americans die each year from this cancer.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer
therapies that target the molecular basis of cancer.  With its partners, the
company is developing small molecule drugs, including BAY 43-9006 with Bayer
Pharmaceuticals Corporation.  For more information about Onyx's pipeline and
activities, visit the company's web site at http://www.onyx-pharm.com/ .

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer
HealthCare, a subgroup of Bayer AG.  Bayer HealthCare is one of the world's
leading innovators in the health care and medical products industry.

Bayer HealthCare combines the global activities of the business groups of Bayer
AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal
Health and Pharmaceuticals.  More than 34,000 employees support the worldwide
operations of Bayer HealthCare.

Our work at Bayer HealthCare is to discover, manufacture and market innovative
products for the purpose of improving human and animal health worldwide. Our
products enhance well-being and quality of life by diagnosing, preventing and
treating disease.

This news release contains forward-looking statements based on current
assumptions and forecasts made by BayerGroup management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in Bayer's public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission (including its
Form 20-F) and Onyx's public reports filed with the U.S. Securities and Exchange
Commission (including its Form 10-K).  The companies assume no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments. 

DATASOURCE: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.



CONTACT:  Mark Bennett of Bayer Pharmaceuticals Corporation,

[phone], or Julie Wood of Onyx Pharmaceuticals, Inc., [phone],

Eileen Crowley of GCI Group, [phone]



Web site:  http://www.onyx-pharm.com/ 

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