Bayer and Onyx Submit New European Marketing Authorization Application to EMEA for Nexavar to Treat Liver Cancer
June 19 2007 - 8:00AM
PR Newswire (US)
Nexavar is First Ever Drug Therapy to Demonstrate Significant
Survival Benefit in Liver Cancer WAYNE, N.J. and EMERYVILLE,
Calif., June 19 /PRNewswire-FirstCall/ -- Bayer HealthCare
Pharmaceuticals, Inc. (NYSE:BAY) and Onyx Pharmaceuticals, Inc.
(NASDAQ:ONXX) today announced that a Marketing Authorization
Application (MAA) has been submitted by Bayer to the European
Medicines Agency (EMEA) in London for the approval to market
Nexavar(R) (sorafenib) tablets within the European Union for the
treatment of hepatocellular carcinoma (HCC), a cancer of the liver.
Nexavar is currently approved in more than 50 countries for the
treatment of advanced kidney cancer. The companies plan to file a
supplemental New Drug Application with the U.S. Food and Drug
Administration for Nexavar in the treatment of liver cancer this
summer. The MAA submission 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-value=0.0006) versus placebo. These results were
presented on June 4, 2007 at the annual meeting of the American
Society of Clinical Oncology. Currently, there are no EMEA-approved
drug therapies that significantly extend survival of liver cancer
patients. "Despite recent progress in cancer treatment, death rates
from liver cancer continue to increase, highlighting the critical
need for new therapeutic options," said Susan Kelley, MD, Vice
President, Therapeutic Area Oncology, Bayer HealthCare
Pharmaceuticals. "Nexavar marks a significant advance for patients
with liver cancer and their families because it is the first drug
therapy ever to demonstrate a significant survival benefit in liver
cancer and it provides this important clinical benefit with a
manageable toxicity profile." Bayer and Onyx halted the SHARP trial
in February 2007 when an independent data monitoring committee
determined that the overall survival endpoint had been met. There
were no significant differences in serious adverse event rates
between the Nexavar and placebo-treated groups, with the most
commonly observed serious adverse events in patients receiving
Nexavar being diarrhea and hand-foot skin reaction. HCC, the most
common form of liver cancer, is responsible for about 90 percent of
the primary malignant liver tumors in adults.(1,2) It is the fifth
most common cancer in the world and the third leading cause of
cancer-related deaths globally.(3,4) Over 600,000 new cases of HCC
are diagnosed globally each year(4) (about 19,000 in the United
States(5) and 32,000 in the European Union(6)), and in 2002
approximately 600,000 people (about 13,000 Americans and 57,000
Europeans) died of HCC.(7) "We are executing on our vision to
change the way cancer is treated(TM). With Bayer, we have
demonstrated that Nexavar significantly improves the lives of
people living with liver cancer in addition to those living with
kidney cancer," said Hollings C. Renton, president and CEO of Onyx.
"We anticipate that the strong adoption of Nexavar in liver cancer
will help fuel our robust development program, which includes
clinical trials studying Nexavar alone and in combination with
other therapies across many different cancer types, including
melanoma, non-small cell lung and breast cancer." Nexavar's
Differentiated Mechanism Nexavar targets both the tumor cell and
tumor vasculature and is the only oral multi-kinase inhibitor that
does not require patients to interrupt their treatment schedule. 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 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 percent for
Nexavar vs. 8 percent for placebo and the incidence of
treatment-emergent cardiac ischemia/infarction was 2.9 percent for
Nexavar vs. 0.4 percent 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 percent for Nexavar vs. 28
percent 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 U.S. Nexavar prescribing
information, visit http://www.nexavar.com/ or call 1.866.NEXAVAR
(1.866.639.2827). Bayer/Onyx Co-Development Nexavar is being
co-developed by Bayer and Onyx. The co-development collaboration
calls for Onyx to fund 50 percent of the development and marketing
costs for Nexavar worldwide, except in Japan. In return, Onyx has a
50/50 profit share in the United States, where the companies
co-promote the product. In all other countries (except Japan) Bayer
has exclusive marketing rights and Onyx's profit share is slightly
less than 50 percent. In Japan, Bayer will fund product development
and Onyx will receive a royalty. 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 Pharmaceuticals Corporation.
Nexavar is approved for the treatment of advanced kidney cancer in
more than 50 countries. For more information about Onyx's pipeline
and activities, visit the company's web site at:
http://www.onyx-pharm.com/. About Bayer HealthCare 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 US, 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, Hematology/Cardiology, Oncology, Primary Care,
Specialized Therapeutics 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 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,
2005, 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. "Change the way cancer is treated" is
a registered trademark of Onyx Pharmaceuticals. 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 World Health Organization. Estimates by WHO
Region: Incidence. Available at:
http://www.who.int/healthinfo/statistics/gbdwhoregionincidence2002.xls.
Accessed April 10, 2007. 4 International Agency for Cancer
Research. GLOBOCAN 2002. Available at: http://www-dep.iarc.fr/.
Accessed April 23, 2007. 5 Jemal A et al. CA Cancer J Clin.
2007;57:43-66. 6 International Agency for Cancer Research. EUCAN
1998. Available at: http://www-dep.iarc.fr/eucan/eucan.htm.
Accessed April 26, 2007. 7 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 10, 2007. DATASOURCE: Bayer
HealthCare Pharmaceuticals, Inc.; 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 Frank Richtersmeier of Bayer Schering Pharma +
49 30 468 17661 or Alicia Samuels (media contact) of GCI Group,
+1-914-720-4635, for Bayer HealthCare Pharmaceuticals, Inc.; 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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