Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. have received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Nexavar (sorafenib) 200 mg film-coated tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
This positive CHMP opinion will be elevated to the European Commission where a positive ruling could lead to Marketing Authorization for all countries in the European Union in the second half of 2006. The companies also announced the approval of Nexavar (sorafenib) tablets by the Mexican Ministry of Health for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer.
Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in the EU as well as in Mexico.
"This positive opinion from the CHMP - received earlier than originally anticipated - marks another important milestone, bringing us one step closer to the global launch of Nexavar," Dr. Gunnar Riemann, Head of Bayer HealthCare's Pharmaceuticals Division said adding, "With the recent approval by the Mexican Ministry of Health, there are now three countries that have approved Nexavar for the treatment of kidney cancer."
Nexavar was approved by the US FDA in December 2005 and in March 2006 in Switzerland. In addition, Bayer has completed filings in several countries, including Australia, Brazil, Canada, and Turkey.
Nexavar is being co-developed by Bayer and Onyx. The co-development collaboration calls for Onyx to fund 50 percent of the development and marketing costs for Nexavar worldwide, except in Japan. In return, Onyx has a 50/50 profit share in the United States, where the companies co-promote the product. In all other countries (except Japan) Bayer has exclusive marketing rights and Onyx's profit share is slightly less than 50 percent. In Japan, Bayer will fund product development and Onyx will receive a royalty.