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 nexavar
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:
onyx-pharm.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (bayerpharma) 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.
Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals,
Inc.
bayerpharma
View drug information on Nexavar.