Wayne, NJ, and South San Francisco, CA. - Jun. 27, 2012
Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX)
announced today that the U.S. Food and Drug
Administration (FDA) has granted priority review
designation to Bayer HealthCare's New Drug Application
(NDA) filed end of April 2012 for the oral multi-kinase
inhibitor regorafenib, for the treatment of patients with
metastatic colorectal cancer (mCRC) whose disease has
progressed after approved standard therapies.
The FDA grants priority review to medicines that provide
a treatment where little or no adequate therapy exists.
Under the Prescription Drug User Fee Act (PDUFA), the FDA
will complete its review within six months from the
receipt of the NDA submission, rather than the standard
10-month review cycle.
The submission was based upon data from the pivotal,
global Phase III CORRECT study.
About Regorafenib
Regorafenib is an investigational oral multi-kinase
inhibitor and is currently being investigated in clinical
trials for its potential to treat patients with various
tumor types.
Regorafenib is an investigational agent and is not
approved by the FDA, EMA or other health authorities.
Regorafenib is one of several cancer compounds in Bayer's
development pipeline. In 2011, Bayer entered into an
agreement with Onyx Pharmaceuticals, Inc., under which
Onyx will receive a royalty on any future global net
sales of regorafenib in oncology. Bayer and Onyx will
co-promote regorafenib in the U.S.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based
pharmaceuticals business of Bayer HealthCare LLC, a
subsidiary of Bayer AG. Bayer HealthCare is one of the
world's leading, innovative companies in the
healthcare and medical products industry, and combines
the activities of the Animal Health, Consumer Care,
Medical Care, and Pharmaceuticals divisions. As a
specialty pharmaceutical company, Bayer HealthCare
provides products for General Medicine, Hematology,
Neurology, Oncology and Women's Healthcare. The
company's aim is to discover and manufacture products
that will improve human health worldwide by diagnosing,
preventing and treating diseases.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx
Pharmaceuticals, Inc. is a global biopharmaceutical
company engaged in the development and commercialization
of innovative therapies for improving the lives of people
with cancer. The company is focused on developing novel
medicines that target key molecular pathways. For more
information about Onyx, visit the company's website
at www.onyx.com.
# # #
Bayer® and the Bayer Cross® are registered trademarks of
Bayer.
Forward-Looking Statements
This news release may contain forward-looking
statements based on current assumptions and forecasts
made by Bayer Group or subgroup 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
which are available on the Bayer website at www.bayer.com. The company
assumes no liability whatsoever to update these
forward-looking statements or to conform them to future
events or developments.
This news release contains "forward-looking
statements" of Onyx within the meaning of the federal
securities laws. These forward-looking statements
include, without limitation, statements regarding the
potential expansion of Onyx's product portfolio, the
possibility of royalty payments to Onyx from the sale of
regorafenib, and the timing, progress and results of
clinical development and the regulatory approval process.
These statements are subject to risks and uncertainties
that could cause actual results and events to differ
materially from those anticipated, including, but not
limited to, risks and uncertainties related to: Nexavar
being our only approved product; we may never receive
marketing approval for Kyprolis (carfilzomib) or
regorafenib; competition; failures or delays in our
clinical trials or the regulatory process; dependence on
our collaborative relationship with Bayer; if approved,
we or Bayer, as the case may be, may be unsuccessful in
launching, maintaining adequate supply of or obtaining
reimbursement for Kyprolis or regorafenib; market
acceptance and the rate of adoption of our products;
pharmaceutical pricing and reimbursement pressures;
serious adverse side effects, if they are associated with
Nexavar, regorafenib or Kyprolis; government regulation;
possible failure to realize the anticipated benefits of
business acquisitions or strategic investments;
protection of our intellectual property; the indebtedness
incurred through the sale of our 4.0% convertible senior
notes due 2016; and product liability risks. Reference
should be made to Onyx's Annual Report on Form 10-K for
the year ended December 31, 2011 filed with the
Securities and Exchange Commission, as updated by Onyx's
subsequent Quarterly Reports on Form 10-Q, under the
heading "Risk Factors" for a more detailed description of
these and other risks. 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.
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