The European Commission recently approved
) Stivarga (regorafenib) for the treatment of adults suffering
from metastatic colorectal cancer (mCRC) whose disease has
progressed even after treatment with standard drugs.
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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,
Biogen Idec Inc.
) look well positioned in the pharma space with a Zacks Rank #1