WAYNE, N.J. and EMERYVILLE, Calif., May 16 NJ-Bayer-Onyx-Announc
WAYNE, N.J. and EMERYVILLE, Calif., May 16 /PRNewswire-FirstCall/ -- Bayer
HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
today announced more than 40 data presentations at the 2008 American Society
of Clinical Oncology (ASCO) annual meeting demonstrating the potential for
Nexavar(R) (sorafenib) tablets in multiple tumor types as a single agent or in
combination with other agents.
"Data at ASCO will expand upon and support the proven efficacy and
tolerability of Nexavar in liver cancer and advanced kidney cancer and provide
new insight into the potential of Nexavar in additional types of cancer," said
Henry Fuchs, MD, executive vice president and chief medical officer of Onyx
Pharmaceuticals. "Highlights include studies demonstrating that Nexavar
extends life for Asian patients with liver cancer; provides an effective,
well-tolerated option for elderly patients with advanced kidney cancer and may
provide benefit and warrants further study in heavily pretreated patients with
non-small cell lung cancer."
Nexavar data highlights include:
Hepatocellular Carcinoma
-- Randomized Phase III trial of sorafenib versus placebo in Asian
patients with advanced hepatocellular carcinoma
-- Ann Lii-Cheng, MD, PhD, department of internal medicine, National
Taiwan University Hospital, Taipei, Taiwan
-- Abstract #4509, oral presentation, Monday, June 02, 2008,
4:30 - 4:45 p.m., E-Hall D2
-- Efficacy and safety of sorafenib in patients with advanced
hepatocellular carcinoma and vascular invasion or extrahepatic spread:
a subanalysis from the SHARP trial
-- Morris Sherman, MD, PhD, associate professor of medicine, University
of Toronto, Toronto, Canada
-- Poster 37G, abstract #4584, poster, Monday, June 2, 2008,
8 a.m. - 12 p.m., S Hall A1
-- Is sorafenib safe and effective in patients with hepatocellular
carcinoma (HCC) in Child-Pugh B (CPB) Cirrhosis?
-- Ghassan Abou-Alfa, MD, internal medicine, Memorial Sloan Kettering
Cancer Center, New York, NY
-- Poster 6, abstract #4518, poster discussion, Tuesday, June 3, 2008,
11 - 11:15 a.m., S406
-- Efficacy and safety of sorafenib in patients with advanced
hepatocellular carcinoma according to ECOG performance status: a
subanalysis from the SHARP trial
-- Jean-Luc Raoul, MD, PhD, Centre Eugene Marquis, Rennes, France
-- Poster 38B, Abstract #4587, Monday, June 2, 2008,
8:00 a.m. - 12:00 p.m., S Hall A1
Renal Cell Carcinoma
-- Safety and efficacy of sorafenib in elderly patients >/=65 years: a
subset analysis from the ARCCs expanded access program in North America
-- Ronald Bukowski, MD, director of experimental therapeutics,
Cleveland Clinic CICF Taussig Cancer Center, Cleveland, OH
-- Poster 17, Abstract #5045, Sunday, June 1, 2008, 8:00 - 12:00 p.m.,
W375e Lobby. Poster discussion period: 11:00 AM - 12:00 p.m., W375a
-- Comparison of kidney cancer symptoms and quality of life (QoL) in renal
cell cancer (RCC) patients receiving sorafenib vs. interferon-a (IFN)
-- Cezary Szczylik, MD, Central Clinical Hospital, Military Institute
of Health, Warsaw, Poland
-- Poster 44E, Abstract #9603, Saturday, May 31, 2008,
2:00 - 6:00 p.m., S Hall A1
-- Updated results of a Phase I trial of sorafenib and bevacizumab in
patients with metastatic renal cell carcinoma (RCC)
-- Jeffrey Sosman, MD, professor of medicine (hematology/oncology),
Vanderbilt-Ingram Cancer Center, Nashville, TN
-- Abstract #5011, Clinical Science Symposium, Saturday, May 31, 2008,
2:15 - 2:30 p.m., W375e
Lung Cancer
-- A randomized discontinuation Phase II study of sorafenib vs placebo in
patients with non-small cell lung cancer who have failed at least two
prior chemotherapy regimens
-- Joan Schiller, MD, professor and chief of the Hematology/Oncology
Division at University of Texas Southwestern and Andrea L. Simmons
Distinguished Chair in Cancer Research, Dallas, TX
-- Abstract #8014, Monday, June 2, 4 - 4:15 p.m., W375e
-- A Phase II trial of BAY 43-9006 in patients with platinum treated
extensive stage small cell lung cancer (E-SCLC): A SWOG (SO435) Phase
II trial
-- Barbara Gitlitz, MD, associate professor of clinical, director,
Lung, Head and Neck Program, USC/Norris Comprehensive Cancer Center,
Los Angeles, CA
-- Poster 20, abstract #8039, poster discussion, Monday, June 2, 2008,
12 - 1 p.m., W375d
Solid Tumors
-- A drug interaction study of sorafenib and rapamycin in patients with
advanced malignancies
-- Tara Gangadhar, MD, fellow, University of Chicago, Chicago, IL
-- Poster 10A, abstract #2545, poster discussion, Sunday, June 1, 2008,
2 - 6 p.m., S Hall A1
-- A phase II study: Combination of sorafenib with docetaxel and cisplatin
in the treatment of metastatic or advanced unresectable gastric and
gastroesophageal junction (GEJ) adenocarcinoma (ECOG 5203)
-- Weijing Sun, MD, assistant professor of medicine, University of
Pennsylvania (Philadelphia, PA) director of Upper GI and
Pancreatic-biliary-hepatic Cancer Group and the associate director
of the GI Cancer Program
-- Poster 23, abstract #4535, poster discussion, Tuesday, June 3, 2008,
11:30 - 11:45 a.m., S406 - Vista Room
-- Activity of sorafenib (SOR) in patients (pts) with imatinib (IM) and
sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST):
A phase II trial of the University of Chicago Phase II Consortium
-- Lauren Wiebe, MD, fellow, University of Chicago, Chicago, IL
-- Abstract #10502, oral presentation, Saturday, May 31, 2008,
8:45 - 9 a.m. W375d
Thyroid Cancer
-- A Phase II study of sorafenib in metastatic thyroid carcinoma
-- Marcia S. Brose, MD, PhD, assistant professor, director of cancer
genetics laboratory, University of Pennsylvania Health System,
Philadelphia, PA
-- Poster 18, abstract #6026, poster discussion, Sunday, June 1, 2008,
8 a.m. - 12 p.m., E450b
"Along with international study groups and investigators, Bayer and Onyx
are committed to a comprehensive clinical trial program evaluating Nexavar for
additional types of cancer including lung cancer, breast cancer, melanoma and
adjuvant use in kidney cancer," Susan Kelley, MD, vice president, Therapeutic
Area Oncology, Bayer HealthCare Pharmaceuticals. "With its proven track record
in two cancers, dual-targeted mechanism and proven tolerability, we continue
to identify important new areas where Nexavar may provide clinical benefit for
people affected by cancer."
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.
Nexavar is currently approved in more than 40 countries for the treatment
of patients with unresectable 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 and 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. In HCC patients, 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. In RCC patients, 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 adverse events >/=20% related to Nexavar for both HCC and RCC were
fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia,
diarrhea, nausea, and abdominal pain. Grade 3/4 adverse events in HCC and RCC
patients, respectively, were 45% for Nexavar vs. 32% for placebo and 38% for
Nexavar and 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 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 http://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, 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.
SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
