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, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced here.
The companies also announced 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.
"The filing of our Marketing Authorization Application is an important step towards making sorafenib available to doctors and patients in the EU," Wolfgang Plischke, President of Bayer HealthCare's Global Pharmaceutical Division said adding, "In the meantime, the initiation of the EU ARCCS trial will provide advanced RCC patients with access to this innovative anti-cancer drug candidate."
Bayer and Onyx have also completed the submission of a New Drug Application (NDA) with the US 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, a novel investigational drug candidate, is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumour cell and tumour vasculature. 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.