The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant...

The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating
Significant Improvement in Overall Survival in Patients With Liver Cancer
- Nexavar is First Approved Systemic Therapy to Treat the Disease -

WAYNE, N.J. and EMERYVILLE, Calif., July 23 /PRNewswire-FirstCall/ --
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
today announced that The New England Journal of Medicine published results of
a Phase 3 trial demonstrating that Nexavar(R) (sorafenib) tablets decreased
the absolute risk of death by 31 percent in patients with unresectable
hepatocellular carcinoma (HCC), or liver cancer, versus patients who received
placebo. This represents a 44 percent improvement in median overall survival
for patients treated with Nexavar.
Based on the strength of these data, Nexavar was approved for HCC by the
European Agency for the Evaluation of Medicinal Products (EMEA) and by the
U.S. Food and Drug Administration (FDA) in October and November 2007,
respectively.
"Despite advances in the management of many other cancers, liver cancer
has remained a treatment challenge, due to a lack of systemic therapies to
extend life and limited opportunity for surgical intervention," said Dr. Josep
M. Llovet, co-principal investigator of the study and professor of research,
Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit, Hospital
Clinic Barcelona; director of research, HCC Program, associate professor of
Medicine, Mount Sinai School of Medicine, New York. "This landmark study
reflects a new systemic standard of care using Nexavar in the first-line
management of liver cancer."
"The number of lives lost to liver cancer continues to increase globally,
due to the prevalence of hepatitis B and C infections," said Jordi Bruix,
co-principal investigator and director of the Barcelona Clinic Liver Cancer
(BCLC) Group; senior consultant, Liver Unit, Hospital Clinic of Barcelona.
"We are encouraged that there is a new treatment option available for liver
cancer that has clearly demonstrated a survival benefit in this patient
population."
The international Phase 3 double-blind, placebo-controlled Sorafenib HCC
Assessment Randomized Protocol (SHARP) trial evaluated 602 liver cancer
patients who had no prior systemic therapy. The primary endpoints of the
study included overall survival and time to symptomatic progression in
patients administered Nexavar versus those who received placebo. Secondary
endpoints included time to progression, disease control rate and safety.
Results were first presented at the American Society of Clinical Oncology
in June 2007.
Median overall survival was 10.7 months for patients who received Nexavar
compared to 7.9 months for patients who received placebo (HR=0.69; p=0.0006).
There was no difference in time to symptomatic progression between patient
groups, based on a patient-reported assessment questionnaire.
Median time to tumor progression was 5.5 months with Nexavar versus 2.8
months with placebo (HR=0.58; p=<0.001). The most common drug-related grade
3/4 events in patients receiving Nexavar were diarrhea and hand-foot-skin
reaction. No indication of imbalances was observed with regard to serious
adverse events between the Nexavar and placebo-treated groups.
"Hepatocellular cancer is the second type of cancer where Nexavar has
demonstrated a meaningful clinical benefit," said Dimitris Voliotis, MD, vice
president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals.
"We are pleased that Nexavar is now available to patients suffering from liver
cancer in the U.S. and Europe and we continue to work with worldwide
regulatory authorities to secure approvals in other regions."
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 addition, chronic hepatitis B (HBV) and C (HCV) viral infections are
the leading causes of primary liver cancer worldwide. In the Asia-Pacific
region, more than eight percent of the general population is infected with HBV
and between two and four percent is infected with HCV. (3,4)
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
This news release may contain forward-looking statements based on current
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, Morality 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 degree 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.

SOURCE Bayer HealthCare Pharmaceuticals; Onyx Pharmaceuticals, Inc.

Mark Bennett of Bayer HealthCare Pharmaceuticals, +1-203-314-5556; or Julie
Wood of Onyx Pharmaceuticals, Inc., +1-510-597-6505; or Geoff Curtis of
WeissComm Partners, +1-312-550-8138, for Bayer HealthCare Pharmaceuticals and
Onyx Pharmaceuticals, Inc.