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Bayer's Stivarga Filed in the EU

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The HealthCare segment of Bayer (BAYRY) recently submitted a marketing authorization application in the EU for Stivarga for the treatment of patients suffering from gastrointestinal stromal tumors (GlST) who were previously treated with two tyrosine kinase inhibitors.

The drug is already approved in the U.S., Japan and several other countries for the GIST indication.

The regulatory filing of Stivarga for the GIST indication in the EU comes close on the heels of the European Commission clearing Stivarga in the metastatic colorectal cancer (mCRC) indication. Stivarga was approved in the EU for the treatment of adults suffering from mCRC whose disease has progressed even after treatment with standard drugs.

Stivarga is also available in the U.S. and Japan for treating patients suffering from mCRC, whose disease progressed even after treatment with standard drugs.

We note that the drug is co-promoted by Bayer and Onyx Pharmaceuticals, Inc. (ONXX) in the U.S. Onyx receives royalty payments from Bayer on all global net sales of Stivarga as per the agreement inked in 2011.

Stivarga sales in the U.S. for the second quarter of 2013 came in at €47 million. We are encouraged by Bayer’s progress with Stivarga in the EU. EU approval for the GIST indication will boost the drug’s sales further.

Meanwhile, the oncology market looks extremely competitive with the presence of big companies like Roche (RHHBY).

Bayer presently carries a Zacks Rank #3 (Hold). Currently, companies like Biogen Idec Inc. (BIIB) look better positioned in the pharma space with a Zacks Rank #1 (Strong Buy).

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