EMEA Grants Orphan Drug Designation to BAY 43-9006 for the Treatment of Renal Cell Carcinoma

EMEA Grants Orphan Drug Designation to BAY 43-9006 for the
Treatment of Renal Cell Carcinoma 


WEST HAVEN, Conn. and RICHMOND, Calif., Aug. 4  /PRNewswire-FirstCall/ -- Bayer
Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc.
(NASDAQ:ONXX) announced today that BAY 43-9006 has been granted orphan drug
status for the treatment of renal cell carcinoma, by the Committee for Orphan
Medicinal Products (COMP) of the European Medicines Agency (EMEA).  BAY 43-
9006 is being evaluated for the treatment of metastatic renal cell carcinoma,
an advanced form of kidney cancer.

BAY 43-9006, a novel investigational drug candidate, is also under review for
Orphan Drug designation by U.S. Food and Drug Administration (FDA). Currently
in worldwide Phase III clinical testing, BAY 43-9006 is a novel RAF kinase and
VEGFR inhibitor that is intended to prevent tumor growth by combining two
important anticancer activities: inhibition of tumor cell proliferation and
tumor angiogenesis.  BAY 43-9006 is being co-developed by Bayer and Onyx.

The EMEA orphan drug designation provides incentives to companies that develop
drugs for diseases affecting less than five in 10,000 people in the European
Union (EU).  The designation provides a drug EU market exclusivity, for a
particular indication, against drugs with the same principal molecular
structural features and which act via the same mechanism.  The market
exclusivity is for a 10-year period if the sponsor complies with certain EMEA
specifications.  The EMEA represents 25 EU countries, including France,
Germany, Italy, Spain and the United Kingdom.

"The orphan drug designation in the EU signifies another important step for
Bayer and Onyx in the development of BAY 43-9006," said Susan Kelley, M.D.,
vice president, Oncology, Bayer Pharmaceuticals Corporation.  "We appreciate
the EMEA's recognition of our efforts and investment to bring BAY 43-9006
forward for the potential benefit of patients with this devastating form of
advanced renal cell cancer."

Renal cell carcinoma is the most common form of kidney cancer.  Nearly 190,000
people worldwide (about 81,000 in Europe) are diagnosed with renal cell
carcinoma each year, and more than 91,000 of them (about 39,000 in Europe) die
from the disease annually.

Orphan Drug Designation

The EMEA's orphan medicinal product designations are based on various criteria
that include: the seriousness of the condition, the availability of other
effective therapies, and the rarity of the condition.  An investigational drug
is granted orphan designation on the basis of potential activity.  An orphan
designation is not a marketing authorization, which can only be granted after
the quality, safety and efficacy of the product are demonstrated.

BAY 43-9006

BAY 43-9006 is being evaluated in multiple tumor types as a single therapy and
in combination with conventional chemotherapeutics.  In preclinical models, BAY
43-9006 has shown anticancer activity in a number of tumor types and has
inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signaling
pathway at the level of RAF kinase.  BAY 43-9006 also exerted an
anti-angiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and
PDGFR and their associated signaling cascades.

Bayer and Onyx have initiated an international, multi-center Phase III trial to
further evaluate the safety and efficacy of BAY 43-9006 in the treatment of
advanced renal cell carcinoma (RCC).  In the trial, approximately 800 people
will participate at sites worldwide.  The primary objective of the randomized
study will be to confirm the early indicators of clinical activity of BAY
43-9006 in RCC, using improvement in survival as the primary endpoint for
assessment of clinical benefit.  The study also will assess time to progression
(TTP), overall response rate, safety, quality of life and the pharmacokinetics
of BAY 43-9006.

For more information on BAY 43-9006 clinical trials, visit
http://www.clinicaltrials.gov/.

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 collaborators,
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 (http://www.bayerpharma.com/) is part of the
worldwide operations of Bayer HealthCare AG, a subgroup of Bayer AG.

Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, is one
of the world's leading, innovative companies in the health care and medical
products industry.

The company combines the global activities of the divisions Animal Health,
Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600
people are employed by Bayer HealthCare worldwide.

Bayer's aim is to discover and manufacture innovative products that will
improve human and animal health worldwide.  Bayer's 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 Bayer Group 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). Bayer assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.

This news release also contains "forward-looking statements" of Onyx within the
meaning of the federal securities laws. These forward-looking statements
include without limitation, statements regarding the timing, progress and
results of the clinical development, regulatory processes and commercialization
efforts of BAY43-9006. These statements are subject to risks and uncertainties
that could cause actual results and events to differ materially from those
anticipated. Reference should be made to Onyx's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 15, 2004 under the
heading "Additional Business Risks" and Onyx's subsequent Quarterly Reports on
Form 10-Q for a more detailed description of such factors. Readers are
cautioned not to place undue reliance on these forward- looking statements that
speak only as of the date of this release. Onyx undertakes no obligation to
update publicly any forward-looking statements to reflect new information,
events or circumstances after the date of this release except as required by
law. 

DATASOURCE: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.



CONTACT:  Lara Crissey of Bayer Pharmaceuticals, [phone]; Helmut

Schaefers of Bayer HealthCare Communications, [phone]; Julie Wood of

Onyx Pharmaceuticals, Inc., [phone]



Web site:  http://www.bayerpharma.com/

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

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