Nexavar Approved for Liver Cancer in China
July 28 2008 - 1:00AM
PR Newswire (US)
- First and only drug therapy to address major Chinese health
concern - WAYNE, N.J. and EMERYVILLE, Calif., July 28
/PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced that the State
Food and Drug Administration (SFDA) of China has approved
Nexavar(R) (sorafenib) tablets for the treatment of patients with
unresectable or metastatic hepatocellular carcinoma (HCC), or liver
cancer. Nexavar is the first and only oral targeted therapy to
significantly improve overall survival in patients with the
disease. The approval was based on two international Phase 3
double-blind, placebo-controlled trials that evaluated more than
800 patients who received no prior systemic therapy. "China has the
highest number of liver cancer patients worldwide with more than
340,000 new cases diagnosed each year and the incidence is
continuing to rise," said Gunnar Riemann, PhD, member of the
Executive Committee of Bayer HealthCare. "We are proud to be at the
forefront of liver cancer treatment with Nexavar and are hopeful
that patients in China can potentially have their lives extended by
treatment with Nexavar." "This is another significant milestone in
a region where patients are in dire need of a therapy that improves
survival," said N. Anthony Coles, MD, president and chief executive
officer, Onyx Pharmaceuticals, Inc. "The approval in liver cancer
in China comes less than two years after the approval in advanced
kidney cancer and proves that Nexavar is and will continue to be an
important foundational therapy in multiple patient populations."
Hepatocellular carcinoma is the most common form of liver cancer
and is responsible for about 90 percent of the primary malignant
liver tumors in adults. Liver cancer is the sixth most common
cancer in the world and the third leading cause of cancer-related
deaths globally. More than 600,000 cases of liver cancer are
diagnosed worldwide each year (more than 400,000 in China, South
Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000
in the United States) and the incidence is increasing. In 2002,
approximately 600,000 people died of liver cancer including
approximately 370,000 in China, South Korea and Japan, 57,000 in
the European Union, and 13,000 in the United States.(1)(2) In the
Asia-Pacific region, more than eight percent of the general
population is infected with chronic hepatitis B and between two and
four percent is infected with chronic hepatitis C.(3)(4) Both
infections are the leading causes of primary liver cancer
worldwide. 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.
Nexavar is currently approved in more than 40 countries for liver
cancer and in more than 70 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 metastatic melanoma, lung
cancer, breast cancer and as an adjuvant therapy for 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, 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. 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. Most common adverse events reported with
Nexavar in patients with unresectable HCC were diarrhea, fatigue,
abdominal pain, weight loss, anorexia, nausea and hand-foot skin
reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% 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 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(R) (sorafenib) tablets, a small
molecule drug. For more information about Onyx, visit the company's
website at: http://www.onyx-pharm.com/. 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
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, General Medicine, Specialty Medicine 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 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 the 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, 2007, 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 HealthCare Pharmaceuticals, Inc. (1) 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 May 2008. (2)
2005 Cancer Register System (CRS) annual report,
http://crs.cph.ntu.edu.tw/crs_c/annual.html. Accessed May 12, 2008.
(3) World Health Organization, Fact Sheet N 164, October 2000.
http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed May
2008. (4) Stanford University School of Medicine, Asian Liver
Center, "FAQ About Hepatitis B," February 2008.
http://liver.stanford.edu/Education/faq.html. Accessed May 2008.
DATASOURCE: Bayer HealthCare Pharmaceuticals; 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, Geoff Curtis of WeissComm Partners,
+1-312-550-8138, for Bayer HealthCare Pharmaceuticals and Onyx
Pharmaceuticals, Inc. Web site: http://www.bayer.com/
http://www.onyx-pharm.com/ http://www.nexavar.com/
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