Bayer and Onyx Initiate Phase 3 Trial of Nexavar in Non-Small Cell Lung Cancer

WAYNE, N.J. and EMERYVILLE, Calif., June 1 /PRNewswire-FirstCall/ -- Bayer
HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
today announced that the companies have begun enrolling patients in an
international Phase 3 trial to evaluate Nexavar(R) (sorafenib) tablets in
patients with non-squamous non-small cell lung cancer (NSCLC) who have failed
two or three previous treatments.

"Nexavar has proven efficacy in liver cancer and kidney cancer and we are
committed to researching Nexavar in a variety of other solid tumors," said
Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer
HealthCare Pharmaceuticals. "Based on the results of a signal generating Phase
2 study, Bayer and Onyx initiated this Phase 3 trial to evaluate Nexavar in
non-small cell lung cancer."

Phase 3 Trial Design
The MISSION (Monotherapy admInistration of Sorafenib in patientS wIth
nOn-small cell luNg cancer) trial, is an international multicenter study that
will enroll approximately 850 patients with advanced relapsed or refractory
non-squamous NSCLC who have failed two or three previous treatments. Patients
will be randomized to receive either Nexavar as single agent or placebo. In
both treatment arms, best supportive care will be provided. The primary
endpoint of this trial is overall survival, and secondary endpoints include
progression-free survival and overall response rate. The safety and
tolerability of the two treatment groups will also be compared.

The study will be conducted at more than 120 sites in North America, South
America, Europe, Africa and the Asia-Pacific region, including Japan. For
information about this study, please visit www.clinicaltrials.gov.

"As the leading cause of cancer deaths worldwide, lung cancer is a complex
disease that requires new therapeutic options for patients," said Laura Brege,
executive vice president and chief operating officer at Onyx Pharmaceuticals.
"We are committed to studying Nexavar to understand how it may play a role in
the treatment paradigm of this difficult-to-treat disease."

About Non-Small Cell Lung Cancer (NSCLC)
NSCLC accounts for 85-90 percent of diagnosed lung cancers(1) and is a disease
in which malignant (cancer) cells form in the tissues of the lung. It is
characterized by several types of lung cancers, each of which grow and spread
in different ways, including: squamous cell carcinoma, adenocarcinoma, and
large cell carcinoma.(1)

Every year 1.4 million people worldwide will be diagnosed with lung cancer and
1.2 million will die from the disease.(2) Nearly 60 percent of Americans
diagnosed with lung cancer die within one year of their diagnosis and 75
percent die within 2 years. These survival rates have not improved in the past
10 years.(3)

Nexavar's Differentiated Mechanism
Nexavar, an oral anti-cancer therapy, is currently approved in more than 70
countries for liver cancer and in more than 80 countries for the treatment of
patients with advanced kidney cancer. 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.

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, breast cancer,
colorectal cancer, lung cancer, ovarian cancer, and as an adjuvant therapy for
kidney cancer and liver 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 www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

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 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 www.onyx-pharm.com.

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, safety, 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, 2008, 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.

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(1) Non-Small Cell Lung Cancer Detailed Guide from American Cancer Society.
Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_4_7x_Lung_Cancer_-_Non-Small_Cell_Detailed_Guide.asp.
Accessed April 9, 2009.
(2) 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 9, 2009.
(3) National Cancer Institute SEER data. Available at:
http://seer.cancer.gov/statistics/. Accessed April 9, 2009

SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.

Media, David Freundel, Bayer HealthCare Pharmaceuticals, +1-917-806-6625; or
Lori Murray of Onyx Pharmaceuticals, Inc., +1-510-597-6394, or Investors,
Julie Wood of Onyx Pharmaceuticals, Inc., +1-510-597-6505