Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc.
(Nasdaq: ONXX) announced that a planned review by an independent data
monitoring committee (DMC) found that Nexavar(R) (sorafenib) tablets
significantly improved overall survival, progression free survival, and
time to progression in an Asia-Pacific regional Phase 3 trial of patients
with advanced hepatocellular carcinoma (HCC), the most common form of liver
cancer. Based on the DMC's recommendation, the trial will be stopped to
allow all patients to receive treatment with Nexavar. Data from this study
will be submitted for presentation at an upcoming scientific meeting.
The Asia-Pacific liver cancer study was conducted at the request of
Asian health authorities in order to provide supplemental information on
Nexavar's efficacy and safety in Asia-Pacific patient populations.
Supplemental regulatory filings have been completed in several
countries/regions including Europe, China and the United States for Nexavar
in the treatment of liver cancer. These filings were based on positive data
from the pivotal Phase 3 SHARP study announced earlier this year.
Additional regulatory submissions for Nexavar in liver cancer are being
finalized.
"Liver cancer incidence continues to rise in the Asia-Pacific region,
due to the high prevalence of hepatitis B virus infection," said Dr.
Ann-Lii Cheng, principal investigator and professor of medicine, National
Taiwan University Hospital. "These study results confirm that Nexavar's
efficacy and tolerability in liver cancer extends across ethnic groups and
geographies and suggest that Nexavar could meet a tremendous unmet need for
patients and families impacted by this devastating disease."
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) In 2002, approximately 600,000 people died
of liver cancer including approximately 360,000 in China, Korea and Japan,
57,000 in Europe and 13,000 in the United States.(4) Risk factors for liver
cancer include ongoing (chronic) infection with hepatitis B virus (HBV)
and/or hepatitis C virus (HCV).(5)
About the Asia-Pacific Liver Cancer Study
This double-blind, randomized, placebo-controlled Phase 3 trial was
designed to evaluate Nexavar in patients with advanced HCC, or primary
liver cancer, who had no prior systemic therapy. The study enrolled 226
patients from sites in China, Korea and Taiwan. The primary objectives of
the study were to compare overall survival, time to progression (TTP) and
progression free survival (PFS) in patients administered Nexavar 400 mg
twice daily versus patients administered placebo.
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 50 countries, including the
United States and those in the European Union, for the treatment of
patients with advanced kidney cancer. Nexavar is also being evaluated by
the companies, international study groups, government agencies or
individual investigators as a single agent or combination treatment in a
wide range of other cancers, including adjuvant therapy for kidney cancers,
metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC).
In addition, the companies recently confirmed that they are going to
conduct a company-sponsored Phase 3 study of Nexavar in the adjuvant
treatment of HCC following the complete removal of early stage liver
cancer.
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 in patients with advanced kidney cancer 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.
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. For more information about Onyx's
pipeline and activities, visit the company's web site at:
onyx-pharm.
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.
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:
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:
hmc.psu.edu/healthinfo/m/malignanthepatoma.htm. Accessed
April 10, 2007.
3. International Agency for Cancer Research. GLOBOCAN 2002. Available at:
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: www-dep.iarc.fr. Accessed April 10,
2007.
5. American Cancer Society. What is Liver Cancer? Available at:
cancer/docroot/CRI/content/CRI_2_2_1X_What_is_liver_cancer_2
5.a sp. Accessed April 10, 2007.
Bayer HealthCare Pharmaceuticals Inc.; Onyx Pharmaceuticals, Inc.
onyx-pharm
View drug information on Nexavar.