January 28, 2008

Nexavar® Approved for the Treatment of Kidney Cancer in Japan

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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