Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
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FDA Grants Orphan Drug Designation to BAY 43-9006 for the
Treatment of Renal Cell Carcinoma
WEST HAVEN, Conn. and RICHMOND, Calif., Oct. 27 /PRNewswire-FirstCall/ --
Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc.
(NASDAQ:ONXX) announced today that sorafenib (BAY 43-9006) has been granted
orphan drug status for the treatment of renal cell carcinoma by the U.S. Food
and Drug Administration (FDA). The compound is being evaluated for the
treatment of metastatic renal cell carcinoma, an advanced form of kidney
cancer. A similar designation has been granted in the European Union by the
Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency
(EMEA). Currently in 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 anticancer activities: inhibition of tumor cell proliferation and
tumor angiogenesis. BAY 43-9006 is being co-developed by Bayer and Onyx.
The FDA orphan drug designation provides incentives to companies that develop
drugs for diseases affecting less than 200,000 people in the United States.
"The orphan drug designation in the U.S. 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. BAY 43-9006
recently received the FDA's fast track designation and both the fast track and
orphan drug designation provide mechanisms for more frequent communications
with the FDA, helping to streamline development as well as the review and
approval process.
BAY 43-9006, a novel investigational drug candidate, has 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. Nearly 190,000
people worldwide (about 32,000 Americans) are diagnosed with renal cell
carcinoma each year, and more than 91,000 of them (about 12,000 Americans) die
from the disease annually.
About Orphan Drug Designation
In the U.S., orphan drug designation provides a drug U.S. market exclusivity
for a particular indication for a seven-year period if the sponsor complies
with certain FDA specifications. Additional incentives for the sponsor include
tax credits related to clinical trial expenses and a possible exemption from
the FDA-user fee. The designation does not shorten the duration of the
regulatory review and approval process. If a product that has orphan drug
designation is the first such product to receive FDA approval for the
disease/indication for which it has such designation, the product is entitled
to orphan product exclusivity, which means that the FDA may not approve any
other applications to market the same drug in the U.S. for the same disease,
except in limited circumstances, for seven years. The FDA may permit additional
companies to market the same drug for the designated condition if such
companies can demonstrate better safety, efficacy, or a major contribution to
patient care. The FDA may also approve more than one product for the same
orphan indication or disease as long as the products are different drugs.
About Onyx Pharmaceuticals
Onyx Pharmaceuticals 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 ( http://www.bayerpharma.com/ ) 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 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 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" 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: Mark Bennett of Bayer Pharmaceuticals Corporation,
+1-203-812-2160; Helmut Schaefers of Bayer HealthCare Communications,
+49-214-30-58308; Julie Wood of Onyx Pharmaceuticals, Inc., +1-510-262-8757
Web site: http://www.bayerpharma.com/
http://www.onyx-pharm.com/