Amgen basks in EU approval of Bayer/Onyx cancer drug Stivarga

The European Commission has stamped an approval on Stivarga (a.k.a. regorafenib) for aggressive cases of colorectal cancer, marking a regulatory victory for Bayer Healthcare and Onyx Pharmaceuticals ($ONXX). Amgen ($AMGN) benefits, too.

Early this week Thousand Oaks, CA-based Amgen hammered out a deal to acquire South San Francisco-based Onyx and all its pharma assets for $10.4 billion. Stivarga, which gained FDA approval for certain cases of colon cancer in September 2012, is one of three approved cancer drugs from Onyx. Bayer developed the compound and Onyx gets a 20% royalty on global sales of the asset.

Onyx made about $19 million from royalties on Stivarga in the first half of this year, making it the No. 3 product from the drug developer behind Nexavar and Kyprolis.

As expected, the European Commission approved Stivarga, an oral multikinase inhibitor, based on Phase III results from the "Correct" study in patients with metastatic colorectal cancer.

The most prized asset in Amgen's buyout of Onyx is the multiple myeloma therapy Kyprolis. And the biotech giant is counting on more love from EU regulators as late-stage clinical trials for the therapy in Europe are ongoing. Kyprolis could hit $3 billion in annual sales in future years, yet the most lofty revenue estimates hinge in part on the EC approving the therapy for the EU market.   

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