August 04, 2004

European Commission Grants Orphan Drug Designation to BAY 43-9006 for the Treatment of Renal Cell Carcinoma

- Bayer Pharmaceuticals Corporation (NYSE: BAY) announced today that BAY 43-9006 has been granted orphan drug status for the treatment of renal cell carcinoma, by the European Commission. BAY 43-9006 is being evaluated for the treatment of metastatic renal cell carcinoma, an advanced form of kidney cancer.

BAY 43-9006, a novel investigational drug candidate, currently in worldwide Phase III clinical testing, is a novel RAF kinase and VEGFR inhibitor that is intended to prevent tumor growth by combining two important anticancer activities: inhibition of tumor cell proliferation and tumor angiogenesis. BAY 43-9006 is being co-developed by Bayer and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX).

The orphan drug designation provides incentives to companies that develop drugs for diseases affecting not more than five in 10,000 people in the European Union (EU). The designation provides a drug EU market exclusivity, for a particular indication, against drugs with the same principal molecular structural features and which act via the same mechanism. The market exclusivity is for a 10-year period if the sponsor complies with certain specifications. The European Commission represents 25 EU countries, including France, Germany, Italy, Spain and the United Kingdom.

"The orphan drug designation in the EU signifies another important step for Bayer and Onyx in the development of BAY 43-9006", said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation. "We appreciate the Commission's recognition of our efforts and investment to bring BAY 43-9006 forward for the potential benefit of patients with this devastating form of advanced renal cell cancer."

Renal cell carcinoma is the most common form of kidney cancer. Nearly 190,000 people worldwide (about 81,000 in Europe) are diagnosed with renal cell carcinoma each year, and more than 91,000 of them (about 39,000 in Europe) die from the disease annually.1

About Orphan Drug Designation
The EMEA's orphan medicinal product designations are based on various criteria that may include: the seriousness of the condition, the availability of other effective therapies, and the rarity of the condition. An investigational drug is granted orphan designation on the basis of potential activity. An orphan designation is not a marketing authorization, which can only be granted after the quality, safety and efficacy of the product are demonstrated.

About Bayer HealthCare AG Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

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 BAY 43-9006 with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at

References: 1-WHO (Globocan 2000)

Forward-looking statements<br/>
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 our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.