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Bayer, Onyx's Co-product Nexavar For Advanced Kidney Cancer ...

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

The companies described the Swiss approval of Nexavar as an entry step into Europe.

In December 2005, the U.S.

FDA approved Nexavar.

Bayer, in September 2005, filed for European Medicines Agency or EMEA regulatory approval.

Pending a favorable review, marketing of Nexavar is possible in the EU countries in the second half of 2006.

In addition, Bayer has completed filings in several countries, including Mexico, Australia, Brazil, Canada, and Turkey.

In the co-development collaboration, Onyx would fund 50% of the development and marketing costs 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.

Bayer shares closed Wednesday's regular trading session at $39.60, up $0.11, on a volume of 422,000 shares.

Onyx stock closed Wednesday's regular trade up $0.48, at $26.75, on a volume of 321,100 shares.