Bayer, Onyx: European medicinal committee gives Nexavar positive recommendation in kidney cancer

By E. Janene Geiss

Philadelphia, April 28 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. said Thursday that they have received a positive opinion from the European Committee for Medicinal Products for Human Use for Nexavar (sorafenib) 200 mg film-coated tablets for the treatment of patients with advanced renal cell carcinoma, or kidney cancer, who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

This positive 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, according to a company news release.

The companies also announced the approval of Nexavar (sorafenib) tablets by the Mexican Ministry of Health for the treatment of patients with advanced kidney cancer.

Nexavar, which has been shown to double progression-free survival in patients with advanced kidney cancer, will be marketed by Bayer in the European Union as well as in Mexico.

Nexavar was approved by the Food and Drug Administration in December and in March in Switzerland. In addition, Bayer said it has completed filings in several countries, including Australia, Brazil, Canada and Turkey.

Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor growth and tumor blood supply - two important cancer growth activities.

Nexavar has been studied in more than 20 tumor types and in nearly 8,000 clinical trial patients, officials said. It is currently in phase 3 clinical trials for the treatment of advanced hepatocellular carcinoma, or liver cancer, and metastatic melanoma, or skin cancer.

A phase 3 clinical trial in non-small cell lung cancer was begun in February.

In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators, officials said.

Nexavar is being co-developed by Bayer and Onyx. The co-development collaboration calls for Onyx to fund 50% 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%. In Japan, Bayer will fund product development and Onyx will receive a royalty.

Onyx, based in Emeryville, Calif., is engaged in the development of novel cancer therapies that target the molecular basis of cancer.

Based in West Haven, Conn., Bayer is part of the operations of Bayer HealthCare AG, a subsidiary of Bayer AG, a health care and medicinal products company.

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