Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use for Treatment of Liver Cancer
September 21 2007 - 8:00AM
PR Newswire (US)
WAYNE, N.J. and EMERYVILLE, Calif., Sept. 21 /PRNewswire-FirstCall/
-- Bayer HealthCare Pharmaceuticals (NYSE:BAY) and Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced that the
European Committee for Medicinal Products for Human Use (CHMP) has
issued a positive opinion, recommending to grant marketing
authorization for Nexavar(R) (sorafenib) tablets for the treatment
of patients with hepatocellular carcinoma (HCC), or liver cancer.
This positive CHMP opinion will be elevated to the European
Commission where a likely favorable ruling could lead to Marketing
Authorization for European Union Member States this year. Nexavar
is currently approved in more than 50 countries for the treatment
of patients with advanced kidney cancer. "The positive opinion
issued by the CHMP marks another significant milestone for Nexavar
in liver cancer," said Gunnar Riemann, Ph.D., member of the Bayer
HealthCare Executive Committee. "The Committee's decision
underscores the potential of Nexavar to become the standard
systemic drug therapy for the treatment of liver cancer." The CHMP
positive opinion was based on data from the Phase 3 Sorafenib HCC
Assessment Randomized Protocol (SHARP) trial which demonstrated
that Nexavar extended overall survival by 44 percent in patients
with HCC (HR=0.69; p=0.0006) versus placebo. There were no
meaningful differences in serious adverse event rates between the
Nexavar and placebo-treated groups with the most commonly observed
serious adverse events in patients receiving Nexavar being diarrhea
and hand-foot skin reaction. Based on these data, a supplemental
New Drug Application for Nexavar was also granted Priority Review
status by the U.S. Food and Drug Administration (FDA) in August.
"This decision, coupled with the Priority Review status granted by
the FDA, means that patients in these regions are one step closer
to a new treatment for their liver cancer," said Hollings Renton,
chairman, president and chief executive officer of Onyx
Pharmaceuticals, Inc. HCC, the most common form of liver cancer, is
responsible for about 90 percent of the primary malignant liver
tumors in adults.(1,2) Liver cancer is the sixth most common cancer
in the world and the third leading cause of cancer-related deaths
globally.(3) Over 600,000 cases of liver cancer are diagnosed
globally each year(3) (about 19,000 in the United States(4) and
32,000 in the European Union(5)) and in 2002 approximately 600,000
people died of liver cancer including 13,000 in the United States,
57,000 in Europe and approximately 360,000 in China, Korea and
Japan.(6) 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, FLT-3 and RET. Preclinical models have also
demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking
signaling through Raf-1 may offer therapeutic benefits in HCC.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of
patients with 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.
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 treatment-emergent adverse events with Nexavar were
diarrhea, rash/desquamation, fatigue, hand-foot skin reaction,
alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar
vs. 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 U.S. Nexavar prescribing
information, visit http://www.nexavar.com/ or call 1.866.NEXAVAR
(1.866.639.2827). About Onyx Pharmaceuticals, Inc. Onyx
Pharmaceuticals, Inc. is a biopharmaceutical company developing
innovative therapies that target the molecular mechanisms that
cause cancer. The company is developing Nexavar(R), a small
molecule drug, 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
HealthCare Pharmaceuticals Bayer HealthCare Pharmaceuticals Inc. is
the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a
division of Bayer AG. Its research and business activities are
focused on the following areas: Diagnostic Imaging,
Hematology/Cardiology, Oncology, Primary Care, Specialized
Therapeutics 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
Bayer Schering Pharma AG, Germany Bayer Schering Pharma is a
worldwide leading specialty pharmaceutical company. Its research
and business activities are focused on the following areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care,
Specialized Therapeutics and Women's Healthcare. With innovative
products, Bayer Schering Pharma aims for leading positions in
specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives
to improve quality of life. Forward Looking Statements 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 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,
2006, 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(R) (sorafenib) tablets is a registered trademark of Bayer
Pharmaceuticals Corporation. References (1). World Health
Organization. Hepatitis B. Available at:
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/.
Accessed April 10, 2007 (2). Penn State Milton S. Hershey Medical
Center College of Medicine. Malignant Hepatoma. Available at:
http://www.hmc.psu.edu/healthinfo/m/malignanthepatoma.htm. Accessed
April 10, 2007. (3). International Agency for Cancer Research.
GLOBOCAN 2002. Available at: http://www-dep.iarc.fr/. Accessed
April 23, 2007. (4). Jemal A et al. CA Cancer J Clin.
2007;57:43-66. (5). International Agency for Cancer Research. EUCAN
1998. Available at: http://www-dep.iarc.fr/eucan/eucan.htm.
Accessed April 26, 2007. (6). Ferlay J, et al., GLOBOCAN 2002.
Cancer Incidence, Mortality and Prevalence Worldwide. IARC
CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at:
http://www-dep.iarc.fr/. Accessed April 10, 2007. DATASOURCE: Bayer
HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. CONTACT:
Mark Bennett, Bayer HealthCare Pharmaceuticals, +1-203-812-2160;
Julie Wood, Onyx Pharmaceuticals, Inc., +1-510-597-650; Media
contacts, Alicia Samuels, GCI Group, +1-914-720-4635; or Hala
Mirza, WeissComm Partners, +1-212-301-7205, both for Bayer
HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. Web site:
http://www.nexavar.com/ http://www.onyx-pharm.com/
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en
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