FDA Grants Orphan Drug Designation to BAY 43-9006 for the Treatment of Renal Cell Carcinoma
October 27 2004 - 7:00AM
PR Newswire (US)
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/
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