Bayer Submits Regorafenib in Japan - Analyst Blog
28 December 2012 - 10:20PM
Zacks
Bayer Yakuhin
Ltd., the Japanese subsidiary of
Bayer AG (BAYRY), submitted a
marketing authorization application for regorafenib to the Ministry
of Health, Labour and Welfare (MHLW) in Japan.
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. (ONXX), per an agreement inked last
year.
Our
Recommendation
We remind investors that the
oncology market is intensely competitive with the presence of
companies like Roche Holding (RHHBY),
Pfizer (PFE) and Novartis
(NVS).
We have a Neutral recommendation on
Bayer. The stock carries a Zacks #3 Rank (Hold). However, other
pharma companies like Sanofi (SNY) carry a Zacks
#2 Rank (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
ONYX PHARMA INC (ONXX): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
(RHHBY): ETF Research Reports
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
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