Nexavar Receives Fast Track Designation from the FDA for Metastatic Liver Cancer
13 June 2006 - 11:00PM
PR Newswire (US)
WEST HAVEN, Conn., and EMERYVILLE, Calif., June 13
/PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation
(NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) announced
today that Nexavar(R) (sorafenib) tablets has been granted Fast
Track designation by the U.S. Food and Drug Administration (FDA)
for the treatment of metastatic hepatocellular carcinoma (HCC), or
liver cancer. Nexavar was approved by the FDA in December 2005 for
the treatment of patients with advanced renal cell carcinoma (RCC).
The Fast Track program is designed to expedite the review of drug
compounds for the treatment of patients with serious or
life-threatening diseases where there is an unmet medical need for
new therapeutic approaches and where the product has the potential
to demonstrate an effect on a serious or life-threatening aspect of
the condition. Fast Track designation allows a company to file a
New Drug Application (NDA) on a rolling basis as data become
available. This permits the FDA to review the filing as it is
received, rather than waiting for the entire document prior to
commencing the review process. With Fast Track designation, there
may be more frequent interactions with the FDA and there may be the
possibility of a priority review, which could decrease the typical
review period. "We are pleased that Nexavar has received Fast Track
designation by the FDA for this difficult-to-treat patient
population, and we look forward to submitting our Phase III data
when the analyses are complete," said Susan Kelley, M.D., vice
president, Oncology, Bayer Pharmaceuticals Corporation. A Phase III
trial of Nexavar administered as a single agent to patients with
advanced liver cancer is currently underway. Recently, this trial
completed patient enrollment. The study is designed to measure
differences in overall survival, time-to-symptom progression and
time-to-tumor progression (TTP) of Nexavar versus placebo. A
randomized Phase II trial for liver cancer patients to evaluate the
efficacy of Nexavar in combination with the chemotherapeutic agent
doxorubicin is currently open and recruiting patients. About
Hepatocellular Carcinoma Hepatocellular carcinoma, also known as
primary liver cancer, is the most common form of liver cancer and
is responsible for 80 percent of the primary malignant liver tumors
in adults. It is the fifth most common cancer in the world. In
2002, approximately 626,000 HCC cases were reported worldwide, with
15,000 cases in the United States and 53,600 in Europe. HCC is most
prevalent in developing countries, particularly in East and
South-east Asia, the Pacific Basin, and sub-Saharan Africa. Of the
626,000 cases worldwide, approximately 410,000 were reported in
Eastern Asia (with 346,000 in China and 40,000 in Japan alone). HCC
causes more than 600,000 deaths annually worldwide. The five-year
relative survival rate is about seven percent. 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-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.
Nexavar has been studied in more than 20 tumor types and in more
than 8,000 clinical trial patients. It has demonstrated
combinability with multiple anticancer agents. Nexavar is also
being evaluated in Phase III clinical trials for the treatment of
metastatic melanoma, or skin cancer, and non-small cell lung cancer
(NSCLC). 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
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% 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 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% for Nexavar
vs. 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. For 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 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: Media - Mark
Bennett, +1-203-812-2160, or Dr. Michael Diehl, +49-214-30-58532,
both of Bayer HealthCare; or Julie Wood of Onyx Pharmaceuticals,
Inc., +1-510-597-6505; or Geoff Curtis of GCI Group,
+1-312-229-8702 Web site: http://www.bayerpharma.com/
http://www.onyx-pharm.com/ http://www.nexavar.com/
Copyright
Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
Historical Stock Chart
From Jul 2023 to Jul 2024