WEST HAVEN, Conn. and EMERYVILLE, Calif., March 21 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. today announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies' pivotal Phase III trial in patients with advanced kidney cancer. Based on its analysis, the DMC has concluded that the trial met its surrogate endpoint -- resulting in statistically significant longer progression-free survival in those patients administered BAY 43-9006 versus those patients administered placebo. As a result of this favorable outcome, Bayer and Onyx plan to prepare a New Drug Application for possible accelerated approval in the United States.

As previously agreed with the U.S. Food and Drug Administration (FDA), the two companies will continue the Phase III study as originally planned to its primary endpoint of overall survival. Bayer and Onyx also intend to submit data from the Phase III study for the upcoming American Society of Clinical Oncology meeting, May 13-17, in Orlando, Florida.

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