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New kidney cancer drug seeks EU nod

The approval to market a new kidney cancer drug sorafenib has been sought in Europe.


13 September,2005: A Marketing Authorization Applications (MAA) has been submitted by Bayer to the European Medicines Agency (EMEA) in London for the approval to market sorafenib within the European Union (EU) for the treatment of advanced Renal Cell Carcinoma (RCC), or kidney cancer. The application has been submitted under the EMEA’s centralized procedure for product approval, which provides review and approval for all countries within the European Union. 

A single-arm phase III trial in the European Union for patients with advanced kidney cancer that have been previously treated. The study, to be managed by Bayer and known as the European Advanced Renal Cell Carcinoma Sorafenib (EU ARCCS) study, will take place at sites in 11 EU countries including Germany, France, UK, Spain, Italy, the Netherlands, and Poland. The study is scheduled to begin this fall, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc announced in a press statement.

Bayer and Onyx have also completed the submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for sorafenib for patients with advanced renal cell carcinoma (RCC), or kidney cancer in July 2005. 

The European and the US submission are based on an ongoing phase III trial in patients with advanced kidney cancer. Results from the study – the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer were presented in May at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).

Sorafenib is being co-developed by Bayer and Onyx. The co-development collaboration calls for Onyx to fund 50 per cent of the development and marketing costs for sorafenib worldwide, except in Japan. In return, Onyx has a 50/50 profit share in the United States, where the companies plan to co-promote the product if approved. In all other countries (except Japan) Bayer has exclusive marketing rights and Onyx's profit share is less than 50 percent. In Japan, Bayer will fund product development and Onyx will receive a royalty. 

Sorafenib, a novel investigational drug candidate, is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In preclinical models, sorafenib targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-ß, KIT, FLT-3 and RET.

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 sorafenib with Bayer Pharmaceuticals Corporation. 

Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare AG, a subgroup of Bayer AG. 

Bayer HealthCare, with sales of approximately 8.5 billion Euro in 2004, is one of the world's leading 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. Bayer HealthCare employed 35,300 people worldwide in 2004.




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