Bayer Yakuhin Ltd.
the Japanese subsidiary of
), submitted a marketing authorization application for
regorafenib to the Ministry of Health, Labour and Welfare (MHLW)
Bayer is looking to get regorafenib approved for treating
patients suffering from metastatic and/or unresectable
gastrointestinal stromal tumors (GIST). The company had earlier
submitted a marketing application for the candidate in Japan for
the treatment of colorectal cancer (CRC) and received priority
review in August this year.
Bayer is seeking approval for regorafenib on the basis of
encouraging data from a phase III study (GRID), which evaluated
patients suffering from metastatic and/or unresectable GIST. The
company conducted the phase III study across the globe including
eight sites in Japan.
Bayer is looking for the US approval of regorafenib for the
GIST indication. A decision from the US Food and Drug
Administration (FDA) should be out in February 2013.
We remind investors that in October this year, the FDA
approved regorafenib, under the trade name of Stivarga, for
treating patients suffering from metastatic colorectal cancer
(mCRC). The company is also looking for EU approval of the drug
in this indication.
We note Bayer will have to make royalty payments on global
sales of Stivarga to
Onyx Pharmaceuticals, Inc.
), per an agreement inked last year.
We remind investors that the oncology market is intensely
competitive with the presence of companies like
We have a Neutral recommendation on Bayer. The stock carries a
Zacks #3 Rank (Hold). However, other pharma companies like
) carry a Zacks #2 Rank (Buy).
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