Nexavar(R) Approved by European Commission for the Treatment of Advanced Kidney Cancer
July 23 2006 - 6:00AM
PR Newswire (US)
WEST HAVEN, Conn. and EMERYVILLE, Calif., July 23 /PRNewswire/ --
Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced that the
European Commission has granted marketing authorization to
Nexavar(R) (sorafenib) tablets for the treatment of patients with
advanced renal cell carcinoma who have failed prior interferon-
alpha or interleukin-2 based therapy or are considered unsuitable
for such therapy. Bayer will commercialize Nexavar in Europe.
"Today's approval of Nexavar, which has shown to double
progression-free survival, is a significant advance in the fight
against kidney cancer," said Dr. Gunnar Riemann, Head of Bayer
HealthCare's Pharmaceuticals Division. "For more than a decade,
Europeans with kidney cancer have not had a new approved treatment.
We are pleased to play a part in addressing this unmet medical
need." The decision by the European Commission to grant marketing
authorization to Nexavar followed a positive opinion issued by the
European Medicines Agency's Committee on Medicinal Products for
Human Use (CHMP) in April this year. Nexavar was approved by the
U.S. Food and Drug Administration (FDA) in December 2005 and has
since been approved in Switzerland, Mexico, Chile, Brazil, Korea,
and Argentina. Regulatory filings have been completed in several
countries, including Australia, Canada, Turkey, and Japan. "Nexavar
delays the progression of kidney cancer and is generally well
tolerated," said Dr. Escudier, head of Immunotherapy and Innovative
Therapy Unit at the Gustave-Roussy Institute in Paris, France, and
co-principal investigator of the pivotal study that led to the
approval of Nexavar by the European Commission. Every year, more
than 200,000 people around the world are diagnosed with kidney
cancer and more than 102,000 die from the disease. In Europe, there
are more than 46,000 new cases of kidney cancer annually. At the
time of diagnosis, the cancer has already metastasized (spread to
distant body locations) in about one-third of people with kidney
cancer. About the Phase III Pivotal Study Nexavar EMEA approval was
based on Phase III data from the largest randomized,
placebo-controlled trial ever conducted in patients with advanced
renal cell carcinoma. In the Phase III study, Nexavar doubled
progression- free survival (PFS) in previously treated patients
when compared to placebo. Progression-free survival measures the
time that a patient lives without evident tumor growth. In this
study, PFS was doubled to a median value of six months in patients
receiving Nexavar as compared to three months for patients
receiving placebo (p-value < 0.000001). All subgroups examined,
including patients who had not received conventional treatment with
biologics, such as interleukin-2 or interferon-alpha, appeared to
benefit as well. In April 2005, Bayer and Onyx discussed the
clinical and statistical significance of this analysis with the
principal investigators, an independent data monitoring committee
(DMC), and with regulatory authorities and decided that it would
not be ethical to continue the study with a placebo-control arm.
The companies immediately recommended that all patients in the
trial be offered access to Nexavar. In parallel, an interim
analysis of overall survival (OS) was conducted. The median overall
survival for placebo was 14.7 months, while the median OS survival
for Nexavar had not been reached (p=0.018, hazard ratio 0.72). In
June 2006, a further interim analysis of OS was presented, based on
367 deaths and after 48 percent of the placebo patients (N=217) had
crossed over to Nexavar. Median OS for this analysis was 19.3
months for Nexavar patients versus 15.9 months for placebo patients
(p=0.015, hazard ratio 0.77). Although these data did not reach the
pre-specified result required for statistical significance and to
stop the OS analysis early, they suggest a favorable survival trend
for patients who received Nexavar. The final analysis of OS is
planned when 540 events are observed. About Nexavar Nexavar is an
oral multi-kinase inhibitor that targets both the tumor cell and
tumor vasculature. In preclinical models, Nexavar targeted 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, and
FLT-3. Nexavar is being studied in a variety of cancers; to date,
more than 8,000 clinical trial patients have received the drug.
Nexavar is currently in Phase III clinical trials for the treatment
of advanced hepatocellular carcinoma (HCC), or liver cancer, and
metastatic melanoma, or skin cancer. Enrollment in both these
trials has been completed. A Phase III clinical trial in non- small
cell lung cancer (NSCLC) for first-line patients was initiated in
February 2006. In addition to company-sponsored trials, there are a
variety of Nexavar studies being sponsored by government agencies,
cooperative groups and individual investigators. Important Safety
Considerations for U.S. Patients Taking Nexavar Based on the
current, 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 engaged in
the development of novel cancer therapies that target the molecular
basis of cancer. With its collaborators, the company is developing
small molecule drugs including Nexavar with Bayer Pharmaceuticals
Corporation. For more information about Onyx's pipeline and
activities, visit the company's web site at:
http://www.onyx-pharm.com/. About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is
part of the worldwide operations of Bayer HealthCare AG, a
subsidiary of Bayer AG. Bayer HealthCare AG, with sales of
approximately 9.4 billion Euros in 2005, is one of the world's
leading, innovative companies in the healthcare and medical
products industry. The company combines the global activities of
the Animal Health, Consumer Care, Diabetes Care, Diagnostics and
Pharmaceuticals divisions. Bayer Pharmaceuticals Corporation is
part of the new Global Pharmaceutical Division, established January
1, 2006, which consists of the former Biological Products and
Pharmaceutical Division and now comprises three business units:
Hematology/Cardiology; Oncology and Primary Care. Bayer HealthCare
AG employed 33,800 people worldwide in 2005. Bayer HealthCare AG's
aim is to discover and manufacture innovative products that will
improve human and animal health worldwide. The products enhance
well-being and quality of life by diagnosing, preventing and
treating disease. 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. DATASOURCE: Bayer Pharmaceuticals
Corporation; Onyx Pharmaceuticals, Inc. CONTACT: Mark Bennett,
+1-203-812-2160, or Helmut Schaefers, +49-214-30- 58308, both of
Bayer Pharmaceuticals; or Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-597-6505 Web site: http://www.bayerpharma.com/
http://www.onyx-pharm.com/ http://www.nexavar.com/
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