BAY 43-9006 Shown to Delay Disease Progression in Phase III

Press Release:

BAY 43-9006 Shown to Delay Disease Progression in Phase III Study in Advanced Kidney Cancer Patients

Press Release
News Article March 2005

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.

This press release is provided in good-faith by Chiltern Magazine Services Ltd ("CMS") as a service to users of www.telecomsinfo.com. Whilst all care is taken in sourcing and preparing material includede here, any error or incorrect content cannot form the basis for any legal action against the site-owner. Users are advised to check the accuracy of any statements before relying upon them. Likewise, any forward-looking statements made by the author of the press release should be treated as such.

CMS, P&A House, Alma Road, Chesham, Bucks. HP5 3HB, UK
Tel: +44 (0)1494 771734
Fax: +44 (0)1494 778994
e-mail: Editor, CMSinfo

For more information about us, visit CMSinfo.