BAY 43-9006 Receives Fast Track Designation From the FDA for Metastatic Kidney Cancer Review
06 April 2004 - 4:25AM
PR Newswire (US)
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, +1-203-812-2160, or Julie Wood of Onyx
Pharmaceuticals, Inc., +1-510-262-8757, Eileen Crowley of GCI
Group, +1-212-537-8116 Web site: http://www.onyx-pharm.com/
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