Nexavar Receives FDA Fast Track Designation for Skin Cancer
20 July 2006 - 11:00PM
PR Newswire (US)
WEST HAVEN, Conn., and EMERYVILLE, Calif., July 20
/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 advanced (including locally unresectable and
metastatic) melanoma, a form of skin 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. The PRISM study, a Bayer and
Onyx initiated Phase III, double-blind, randomized, placebo
controlled trial of Nexavar administered in combination with a
standard dosing schedule (21-day cycles) of carboplatin (AUC 6) and
paclitaxel (225 mg/m2) is currently underway, having recently
completed patient enrollment. The study is designed to measure the
safety and efficacy of Nexavar when co-administered with
chemotherapy, and has progression-free survival as its primary
endpoint. Approximately 250 patients with disease progression
following one previous systemic chemotherapeutic treatment (with
either dacarbazine (DTIC) or temozolomide) were enrolled into the
study. In addition, a Phase III double-blind, randomized,
placebo-controlled trial, sponsored by the Eastern Cooperative
Oncology Group (ECOG), is underway. The trial will evaluate
carboplatin and paclitaxel with or without the administration of
Nexavar in patients with unresectable Stage III or Stage IV
melanoma, and has overall survival as its primary endpoint. About
Melanoma Cancer of the skin (nonmelanoma and melanoma skin cancers
combined) is the most common type of cancer, accounting for more
than 50 percent of all cancers. In some parts of the world,
especially among Western countries, melanoma is becoming more
common every year. In the United States, for example, the
percentage of people who develop melanoma has more than doubled in
the past 20 years. Melanoma accounts for about four percent of skin
cancer cases but causes about 79 percent of skin cancer deaths. In
2002, about 160,000 people worldwide (about 53,000 Americans) were
diagnosed with melanoma and more than 40,000 of them (about 7,500
Americans) died from the disease. In 2006, Cancer Statistics
Analysis estimates 62,190 newly diagnosed cases and 7,910 deaths
projected in the United States. For more information on melanoma,
visit the Melanoma International Foundation (MIF) web site at:
http://www.melanomainternational.org/. 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. It
has demonstrated combinability with multiple anticancer agents.
Nexavar is also being evaluated in Phase III clinical trials for
the treatment of hepatocellular carcinoma (HCC), or liver cancer
and was granted Fast Track designation for this disease in June
2006. Nexavar is also being evaluated in a Phase III clinical trial
for 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: Mark Bennett of
Bayer HealthCare, +1-203-812-2160; or Julie Wood of Onyx
Pharmaceuticals, Inc., +1-510-597-6505; or Dr. Michael Diehl of
Bayer HealthCare, +49-214-30-58532; or Kelly Thornicroft of GCI
Group, +1-312-229-8711 Web site: http://www.bayerpharma.com/
http://www.onyx-pharm.com/ http://www.nexavar.com/
http://www.melanomainternational.org/
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