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collectBayerNews_20080128_0027_en.pdf BayerNews_20080128_0027_en.pdf
First approved oral targeted therapy for metastatic RCC in Japan
Berlin, January 28, 2008 - Bayer has been granted marketing approval of
Nexavar® in Japan for the treatment of advanced renall cell carcinoma (RCC),
the most common form of kidney cancer. Nexavar is an oral multi-kinase
inhibitor jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals,
Inc. which targets both the tumor cell and tumor vasculature. In Japan, Nexavar
is the first approved oral targeted therapy for metastatic RCC.
"This approval of Nexavar is a crucial step for patients with advanced kidney
cancer in Japan", said Dr. Gunnar Riemann, member of the Board of Management of
Bayer Schering Pharma AG. "This is also a major accomplishment for the
company's oncology franchise in Japan."
The new drug application (NDA) for Nexavar in RCC was filed in June 2006. In
September 2007, an additional application for the treatment of hepatocellular
carcinoma (HCC) was filed. Japanese authorities recently granted priority
review status for Nexavar in this indication.
About renal cell carcinoma (RCC)
Every year, more than 200,000 people around the world are diagnosed with kidney
cancer and more than 100,000 die from the disease. At the time of diagnosis,
the cancer has already metastasized (spread to distant body locations) in about
one-third of people with kidney cancer.
RCC is the most common kidney cancer. In Japan, there are ca. 10,000 patients
suffering from kidney cancer, and 80-85% are diagnosed RCC.
Nexavar's Differentiated Mechanism
Nexavar® targets both the tumor cell and tumor vasculature. 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.
Nexavar is currently approved in more than 30 countries for liver cancer and in
more than 60 countries for the treatment of patients with advanced kidney
cancer, including the United States and the European Union. In Europe, Nexavar
is approved for the treatment of hepatocellular carcinoma and for the treatment
of patients with advanced renal cell carcinoma (RCC) who have failed prior
interferon-alpha or interleukin-2 based therapy or are considered unsuitable
for such therapy. Nexavar is also being evaluated by the companies,
international study groups, government agencies, and individual investigators
as a single agent or combination treatment in a wide range of other cancers,
including adjuvant therapy for kidney cancers, breast cancer, non-small cell
lung cancer (NSCLC), and metastatic melanoma.
Bayer / Onyx Collaboration
Nexavar is being co-developed by Bayer and Onyx Pharmaceuticals, Inc. Under the
collaboration, each company funds half of the development and marketing costs
for Nexavar worldwide, except in Japan. In the U.S., Bayer and Onyx co-promote
Nexavar and share equally in any resulting profits. In all other countries
(except Japan), Bayer has exclusive marketing rights, though the two companies
also share profits. In Japan, Bayer funds all product development and marketing
costs, and Onyx receives a royalty on sales.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
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 the quality of life. Find more information at
www.bayerscheringpharma.de.
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