Bayer and Onyx Announce Nexavar Data Presentations at 60th American Association for the Study of Liver Diseases Annual Meeting
29 October 2009 - 11:00PM
PR Newswire (US)
WAYNE, N.J. and EMERYVILLE, Calif., Oct. 29 /PRNewswire-FirstCall/
-- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals,
Inc. (NASDAQ: ONXX) today announced that more than 25 studies
evaluating the use of Nexavar® (sorafenib) tablets in liver cancer
will be presented at The Liver Meeting®, the 60th Annual Meeting of
the American Association for the Study of Liver Diseases (AASLD).
Nexavar is the only systemic treatment to demonstrate prolonged
survival in patients with hepatocellular carcinoma (HCC), the most
common form of liver cancer, and is currently approved in more than
80 countries for the treatment of the disease. "Bayer and Onyx are
committed to further evaluating Nexavar in patients with HCC to
find the safest and most effective treatment regimens to help liver
cancer patients better manage their disease," said Mark Gelder,
vice president, Bayer Global Medical Affairs, Oncology. "While we
are encouraged by the role Nexavar has played in treating these
patients, we continue to evaluate Nexavar in a variety of treatment
settings, including in combination with TACE and other systemic
therapies, and as a monotherapy in the adjuvant setting." Nexavar
data highlights include: Phase II Trial of Sorafenib Combined with
Doxorubicin Eluting Bead-Transarterial Chemoembolization (DEB-TACE)
for Patients with Hepatocellular Carcinoma (HCC): Interim Safety
and Efficacy Analysis -- Jean-Francois Henri Geschwind, The Johns
Hopkins University School of Medicine, Baltimore, MD -- Monday,
November 2, 2009, 8:00 a.m. - 8:00 p.m., Exhibit Hall C -- Late
Breaker #9 First-in-men Demonstration of Sorafenib Plus TACE for
the Treatment of Advanced Hepatocellular Carcinoma (SOCRATES trial)
-- Dr. Andreas Erhardt, Klinik fur Gastroenterologie, Hepatologie
und Infektiologie, Heinrich-Heine-Universitat Dusseldorf,
Dusseldorf, Germany -- Tuesday, November 3, 2009, 8:00 a.m. - 1:00
p.m., Exhibit Hall C -- Abstract #1675 Efficacy and Safety of
Sorafenib in Patients from the Asia-Pacific (AP) Region with
Advanced Hepatocellular Carcinoma (HCC): Impact of Prior
Transarterial Chemoembolization and Transarterial Embolization
(TACE/TAE) -- Dr. Zhendong Chen, First Affiliated Hospital of Anhui
Medical University, Hefei, China -- Tuesday, November 3, 2009, 8:00
a.m. - 1:00 p.m., Exhibit Hall C -- Abstract #1694 "Liver cancer is
often diagnosed at an advanced stage when patients tend to be very
ill due to pre-existing liver disease," said Todd Yancey, M.D.,
vice president of clinical development at Onyx. "Onyx and Bayer are
committed to evaluating Nexavar in ongoing studies, as will be
presented at AASLD, in order to realize the potential benefit the
therapy may offer to patients at all stages of the disease and in
different treatment settings." Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In
preclinical studies, Nexavar has been shown to target members of
two classes of kinases known 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, PDGFR-B, KIT,
c-FLT-3 and RET. Nexavar is currently approved in more than 80
countries for the treatment of patients with liver cancer and in
more than 90 countries for the treatment of patients with advanced
kidney cancer. Nexavar is also being evaluated by the companies,
international study groups, government agencies and individual
investigators as a single agent or combination treatment in a wide
range of cancers, including breast cancer, colorectal cancer, lung
cancer, ovarian cancer, and as an adjuvant therapy for liver cancer
and kidney cancer. 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 http://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
unit of Bayer HealthCare LLC, a division of Bayer AG. One of the
world's leading, innovative companies in the healthcare and medical
products industry, Bayer HealthCare combines the global activities
of the Animal Health, Consumer Care, Diabetes Care, and
Pharmaceuticals divisions. In the U.S., Bayer HealthCare
Pharmaceuticals comprises the following business units: Women's
Healthcare, Diagnostic Imaging, Specialized Therapeutics,
Hematology/Cardiology and Oncology. 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. For more
information about Onyx, visit the company's website at
http://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 http://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,
2008, 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. DATASOURCE: Onyx Pharmaceuticals, Inc.; Bayer
HealthCare Pharmaceuticals Inc. CONTACT: Media, David Freundel,
Bayer HealthCare Pharmaceuticals, +1-973-305-5310, or Lori Murray
of Onyx Pharmaceuticals, Inc., +1-510-597-6394; or Investors, Julie
Wood of Onyx Pharmaceuticals, Inc., +1-510-597-6505 Web Site:
http://www.onyx-pharm.com/ http://www.bayer.com/
Copyright