Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer
June 27 2007 - 8:00AM
PR Newswire (US)
Nexavar is First Drug Therapy to Demonstrate Significant Survival
Benefit in Liver Cancer WAYNE, N.J. and EMERYVILLE, Calif., June 27
/PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals Inc.
(NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced that a Supplemental New Drug Application (sNDA) for
Nexavar(R) (sorafenib) tablets has been submitted to the U.S. Food
and Drug Administration (FDA) for the treatment of patients with
hepatocellular carcinoma (HCC), the most common form of liver
cancer. Nexavar is currently approved in more than 50 countries for
the treatment of advanced kidney cancer. The companies also
confirmed that they are planning a company- sponsored Phase 3 study
of Nexavar in the adjuvant treatment of HCC following the complete
removal of early stage liver cancer. The sNDA submission is based
on positive data from the international, Phase 3,
placebo-controlled 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 significant differences in serious
adverse event rates between the Nexavar and placebo-treated groups
with the most commonly observed adverse events in patients
receiving Nexavar being diarrhea and hand-foot skin reaction.
Currently, there are no FDA-approved drug therapies that
significantly extend survival of patients with liver cancer. "These
results are particularly meaningful considering that death rates
from liver cancer continue to increase," said Susan Kelley, M.D.,
vice president, Therapeutic Area Oncology, Bayer HealthCare
Pharmaceuticals. "After more than 100 clinical studies of many
agents over three decades, Nexavar is the first drug therapy to
demonstrate a significant survival benefit for patients with HCC,
and, if approved, may fulfill a serious unmet need with a
manageable toxicity profile." HCC, the most common form of liver
cancer, is responsible for about 90 percent of the primary liver
cancers in adults.(1,2) It is the fifth most common cancer in the
world(3) and the third leading cause of cancer-related deaths
globally.(4) Over 600,000 cases of HCC are diagnosed globally each
year(4) (about 19,000 in the United States(5) and 32,000 in the
European Union(6)) and in 2002 approximately 600,000 people (about
13,000 Americans and 57,000 Europeans) died of HCC.(7) "This filing
exemplifies our commitment to providing valuable therapeutic
options for significant unmet needs in cancer treatment," said Hank
Fuchs, M.D., executive vice president and chief medical officer of
Onyx. "We believe that Nexavar will become the reference standard
of care in HCC, and will help advance our development program,
which includes clinical trials studying Nexavar alone and in
combination with other therapies across many different cancer
types, including melanoma, non-small cell lung and breast cancer."
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. Nexavar is
approved for the treatment of advanced kidney cancer in more than
50 countries. For more information about Onyx's pipeline and
activities, visit the company's web site at:
http://www.onyx-pharm.com/. About Bayer HealthCare 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 US, 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
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. World Health Organization. Estimates by WHO
Region: Incidence. Available at:
http://www.who.int/healthinfo/statistics/gbdwhoregionincidence2002.xls.
Accessed April 10, 2007. 4. International Agency for Cancer
Research. GLOBOCAN 2002. Available at: http://www/ dep.iarc.fr.
Accessed April 23, 2007. 5. Jemal A et al. CA Cancer J Clin.
2007;57:43-66. 6. International Agency for Cancer Research. EUCAN
1998. Available at: http://www-dep.iarc.fr/eucan/eucan.htm.
Accessed April 26, 2007. 7. 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 Inc.; Onyx Pharmaceuticals, Inc.
CONTACT: Mark Bennett of Bayer HealthCare Pharmaceuticals,
+1-203-314-5556; or Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-597-6505; or media, Alicia Samuels of GCI Group,
+1-914-720-4635; or media, Hala Mirza of WeissComm Partners,
+1-917-929-1734 Web site: http://www.nexavar.com/
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