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Bayer's Stivarga Cleared in the EU

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The European Commission recently approved Bayer’s (BAYRY - Free Report) Stivarga (regorafenib) for the treatment of adults suffering from metastatic colorectal cancer (mCRC) whose disease has progressed even after treatment with standard drugs.

The EU approval of Stivarga did not come as a surprise as, in Jun 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on the approval of Stivarga in the mCRC indication.

The European approval of Stivarga was based on positive results from Bayer’s phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) study. Results from the study revealed that overall survival and progression-free survival improved in patients who were treated with Stivarga plus best supportive care.

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

Apart from the mCRC indication, the drug is also approved for the treatment of patients suffering from locally advanced, metastatic gastrointestinal stromal tumor (GIST) in the U.S. and Japan besides several other countries.

Stivarga sales in the U.S. for the second quarter of 2013 came in at €47 million. The EU approval of the drug is expected to boost its sales in the coming quarters.

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

Bayer presently carries a Zacks Rank #3 (Hold). Currently, companies like Actelion Ltd. and Biogen Idec Inc. (BIIB - Free Report) look well positioned in the pharma space with a Zacks Rank #1 (Strong Buy).

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