Nexavar Becomes First and Only Approved Treatment of Hepatocellular Carcinoma in Europe
October 30 2007 - 8:15AM
PR Newswire (US)
Only Systemic Therapy Shown to Significantly Extend Overall
Survival in Patients with Most Common Form of Liver Cancer WAYNE,
N.J. and EMERYVILLE, Calif., Oct. 30 /PRNewswire-FirstCall/ --
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.
(NASDAQ:ONXX) today announced that the European Commission has
granted marketing authorization to Nexavar(R) (sorafenib) tablets
for the treatment of patients with hepatocellular carcinoma (HCC),
the most common form of liver cancer. Nexavar, an oral anti-cancer
drug, is the first approved systemic therapy for HCC and the only
one shown to significantly improve overall survival in patients
with the disease. Additional regulatory filings for HCC are under
review in countries around the world including the United States
and, most recently, Japan. Nexavar is currently approved in more
than 60 countries for the treatment of patients with advanced
kidney cancer. "The approval of Nexavar, a novel multi-kinase
inhibitor, represents an unprecedented advance for patients with
HCC who, until now, had no approved systemic treatment options,"
said Arthur Higgins, chairman of the Executive Committee of Bayer
HealthCare. "This milestone will likely establish Nexavar as the
standard systemic therapy for the treatment of HCC and shows the
dedication of health authorities to make Nexavar available as
quickly as possible. Most importantly, it allows us to offer
patients and medical professionals the potential to improve
treatment outcomes for this devastating disease." "Liver cancer is
one of the cancers in which the number of related deaths continues
to increase," said Hollings C. Renton, chairman, president and
chief executive officer of Onyx Pharmaceuticals, Inc. "This second
approval for Nexavar -- first in advanced kidney cancer and now,
less than two years later in HCC, demonstrates our commitment to
expediting the clinical development of this innovative therapy to
treat today's unmet needs in cancer. We will move swiftly to make
Nexavar rapidly available to patients." The European Commission's
decision to approve Nexavar 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. In the study, median overall
survival was 10.7 months in Nexavar-treated patients compared to
7.9 months in those taking placebo. No indication of imbalances was
observed in serious adverse events 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. Based on these data, a supplemental New Drug
Application for Nexavar was granted Priority Review status by the
U.S. Food and Drug Administration (FDA) in August. These data,
along with Phase 1 safety data, were submitted as part of a
Marketing Authorization Application in Japan. 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 worldwide each year(3) (about 54,000* in
Europe,4 19,000 in the United States,(5) and 390,000 in China,
Korea and Japan(4)) and incidence is increasing.(6) In 2002
approximately 600,000 people died of liver cancer including 57,000*
in Europe, 13,000 in the United States, and approximately 360,000
in China, Korea and Japan.(4) Currently, the 5-year survival rate
for patients with liver cancer in Europe is less than 8 percent.(7)
The 5-year survival rate for liver cancer patients is 11 percent in
the United States,(8) and less than 10 percent in Asia among
patients with non-resectable tumors.(9) 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 A supplemental New Drug
Application has been submitted to the U.S. Food and Drug
Administration for Nexavar in the treatment of liver cancer, and is
currently under review. 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
information on Nexavar, including U.S. 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 HealthCare Pharmaceuticals Inc. 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 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.
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 our annual and
interim reports filed with the Frankfurt Stock Exchange. 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 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
HealthCare Pharmaceuticals Inc. 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. 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 October 15, 2007. 5. Jemal A et
al. CA Cancer J Clin. 2007;57:43-66. 6. Ries LAG, Melbert D,
Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L, Horner MJ,
Howlader N, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer
Statistics Review, 1975-2004, National Cancer Institute. Bethesda,
MD, http://seer.cancer.gov/csr/1975_2004/, based on November 2006
SEER data submission, posted to the SEER web site, 2007 7.
Capocaccia, R. et al., "Hepatocellular Carcinoma: Trends of
Incidence and Survival in Europe and the United States at the End
of the 20th Century." American Journal of Gastroenterology
2007;102: 1661-1667. 8. American Cancer Society. Cancer Facts &
Figures 2007. Atlanta: American Cancer Society: 2007. 9. Teo, T.K.
and Fock, K.M. "Hepatocellular Carcinoma: An Asian Perspective."
Digestive Diseases 2001:19: 263-268. * Note on HCC in Europe: The
reported mortality of HCC is higher than the incidence of HCC in
Europe. This is due to the overestimation of mortality by
occasional counting of metastatic cancers that have spread to the
liver, and underestimation of incidence as a result of a lack of
technology for early detection and diagnosis of HCC. Source:
International Agency for Research on Cancer. 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
Catey Laube (media contact) of GCI Group, +1-212-537-8247; or Hala
Mirza (media contact) of WeissComm Partners, +1-212-301-7205 Web
site: http://www.onyx-pharm.com/ http://www.nexavar.com/
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