EMEA Grants Orphan Drug Designation to BAY 43-9006 for the Treatment of Renal Cell Carcinoma
August 04 2004 - 11:12AM
PR Newswire (US)
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, +1 203-812-6558; 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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