The HealthCare unit of
) recently submitted a new drug application (NDA) with the US Food
and Drug Administration (FDA) for its cancer candidate regorafenib.
Bayer is looking to get regorafenib, an oral multi-kinase
inhibitor, approved for treating patients suffering from metastatic
and/or unresectable gastrointestinal stromal tumors (GIST).
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Bayer is seeking approval of the candidate on the basis of
encouraging data from a phase III study (GRID: n=199), which
evaluated patients suffering from metastatic and/or unresectable
gastrointestinal stromal tumors. The disease had progressed in the
evaluated patients in spite of being previously treated with
) Gleevec and
) Sutent. The data was presented at the June 2012 annual conference
of the American Society of Clinical Oncology (ASCO).
We note that Bayer is also seeking approval of regorafenib for
treating patients suffering from metastatic colorectal cancer
(mCRC) both in Europe and the US. The marketing applications were
based on encouraging data from a phase III study (CORRECT: n=760),
which evaluated regorafenib in mCRC patients, whose disease had
progressed even after treatment with the standard drugs prescribed
for the disease.
The FDA announced in June 2012 that it will review the marketing
application, filed in April 2012, for mCRC on a priority basis.
Priority review status means that the FDA will review the marketing
application within six months instead of the standard ten months. A
response is expected in the fourth quarter of 2012.
Once regorafenib is commercialized, Bayer will have to make royalty
payments on global sales of the candidate to
Onyx Pharmaceuticals, Inc.
), per an agreement inked last year.
We have a Neutral recommendation on Bayer. The stock carries a
Zacks #3 Rank (Hold rating) in the short run.