MILAN, Oct. 7 /PRNewswire/ -- Bayer HealthCare
Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
today announced that more than 20 studies evaluating the use of
Nexavar® (sorafenib) tablets will be presented at the 35th European
Society for Medical Oncology (ESMO) Congress, October 8-12, 2010 in Milan, Italy.
"It's been almost five years since the approval of Nexavar in
its first indication, advanced kidney cancer, and since that time
the continuum of development in other areas has produced clinically
significant findings, leading to a second approval in unresectable
liver cancer," said Dimitris
Voliotis, Vice President, Global Clinical Development
Oncology, Bayer HealthCare. "Our dedication to the development of
Nexavar is demonstrated by the array of data being presented at
this year's ESMO Congress as well as the ongoing clinical trial
program evaluating Nexavar in a variety of treatment settings and
patient types."
Nexavar's Differentiated Mechanism
Nexavar, an oral anti-cancer therapy, is currently approved in
more than 95 countries for liver cancer where it remains the only
approved systemic agent proven to extend survival and in more than
95 countries for the treatment of patients with advanced kidney
cancer. Nexavar inhibits processes involved in both the tumor
cell and tumor vasculature. In preclinical studies, Nexavar
has been shown to inhibit members of two classes of kinases thought
to be involved in both cell proliferation (growth) and angiogenesis
(blood supply) – two important processes that enable cancer growth.
These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3,
PDGFRB, KIT, FLT-3 and RET.
Nexavar is also being evaluated by the companies, international
study groups, government agencies and individual investigators.
Important Safety Considerations For Patients Taking
Nexavar
Based on the currently approved U.S. package insert for the
treatment of patients with unresectable hepatocellular carcinoma
and advanced kidney cancer, hypertension may occur early in the
course of therapy and blood pressure should be monitored weekly
during the first six weeks of therapy and treated as needed.
In HCC patients, bleeding with a fatal outcome from any site
was reported in 2.4% for Nexavar and 4% in placebo. The
incidence of treatment-emergent cardiac ischemia/infarction was
2.7% for Nexavar vs. 1.3% for placebo. In RCC patients,
incidence of bleeding regardless of causality was 15% for Nexavar
vs. 8% for placebo and the incidence of treatment-emergent cardiac
ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo.
Most common adverse events >20% related to Nexavar for
both HCC and RCC were fatigue, weight loss, rash/desquamation,
hand-foot skin reaction, alopecia, diarrhea, nausea, and abdominal
pain. Grade 3/4 adverse events in HCC and RCC patients,
respectively, were 45% for Nexavar vs. 32% for placebo and 38% for
Nexavar and 28% for placebo. Women of child-bearing potential
should be advised to avoid becoming pregnant and advised against
breast-feeding. In cases of any severe or persistent side
effects, temporary treatment interruption, dose modification or
permanent discontinuation should be considered.
For information about Nexavar including U.S. Nexavar prescribing
information, visit www.nexavar.com or call 1.866.NEXAVAR
(1.866.639.2827).
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, Diabetes Care, and Pharmaceuticals divisions.
As a specialty pharmaceutical company, Bayer HealthCare
Pharmaceuticals provides products for Diagnostic Imaging, 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.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company
committed to improving the lives of people with cancer. The
company, in collaboration with Bayer HealthCare Pharmaceuticals
Inc., is developing and marketing Nexavar® (sorafenib) tablets, a
small molecule drug that is currently approved for the treatment of
liver cancer and advanced kidney cancer. Additionally, Nexavar is
being investigated in several ongoing trials in a variety of tumor
types. Beyond Nexavar, Onyx has established a development pipeline
of anticancer compounds at various stages of clinical testing,
including carfilzomib, a selective proteasome inhibitor, that is
currently being evaluated in multiple clinical trials for the
treatment of patients with relapsed or relapsed/refractory multiple
myeloma and solid tumors. ONX 0801, an alpha-folate receptor
targeted inhibitor of thymidylate synthase, and ONX 0912, an oral
proteasome inhibitor, are currently in Phase 1 testing. For more
information about Onyx, visit the company's website at
www.onyx-pharm.com.
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 Web site 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 also contains "forward-looking statements"
of Onyx within the meaning of the federal securities laws.
These forward-looking statements include without limitation,
statements regarding timing, progress and results of the clinical
development, safety, regulatory processes, commercialization
efforts or commercial potential of Nexavar. 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
for the year ended December 31, 2009,
filed with the Securities and Exchange Commission under the heading
"Risk Factors" and Onyx's 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.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer
HealthCare Pharmaceuticals, Inc.
SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx
Pharmaceuticals, Inc.
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