) recently announced positive data on its ulcerative colitis (UC)
candidate, etrolizumab (RG7413), from EUCALYPTUS, a phase II
induction study (n=124).
The study is evaluating the efficacy and safety of etrolizumab
for the treatment of moderate-to-severely active ulcerative
The study met its primary endpoint of clinical remission at
week 10. Roche observed that patients suffering from
moderate-to-severely active UC treated with etrolizumab showed
significantly higher rates of clinical remission compared to
placebo at week 10.
Moreover, it was observed that etrolizumab was well tolerated
without any significant safety concerns.
According to the press release issued by Roche, approximately
0.9 million people suffer from UC in the US and Western Europe.
Hence, the successful development and commercialization of
etrolizumab bodes well for Roche given the sales potential.
However, the course might not be easy for Roche given the
existing stiff competition. We note that
) already has approved drugs like Lialda in the US for the
treatment of patients with mild to moderately active
Lialda was one of the best selling drugs for Shire in the
first quarter of 2013 driven by an increased market share in the
) Humira was approved by the European Commission and US Food and
Drug Administration (FDA) in 2012 for the treatment of moderate
to severe UC in adult patients, who responded inadequately to
Nevertheless, we continue to be encouraged with the recent
pipeline progress at Roche. Earlier in the month, Roche released
positive initial results on its oncology candidate, obinutuzumab
(GA101), from CLL11, a phase III study.
In addition, Roche obtained FDA approval for Tarceva
(erlotinib) for the first-line treatment of patients suffering
from metastatic non-small cell lung cancer.
Roche currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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