The HealthCare segment of
) recently submitted a regulatory application for its chronic
thromboembolic pulmonary hypertension (CTEPH) candidate,
riociguat, in Japan.
Bayer mentioned in its press release that riociguat is the
first candidate to demonstrate clinical efficacy in the treatment
of inoperable CTEPH patients or patients suffering from
persistent or recurrent CTEPH after surgery. The regulatory
submission of riociguat was on the basis of positive results from
the placebo-controlled pivotal, global phase III CHEST-1
Results from the study revealed that after 16 weeks, riociguat
showed a statistically significant improvement from baseline in
the six-minute walk test compared to placebo. Riociguat was also
well tolerated during the study.
We note that riociguat is currently under the US Food and Drug
Administration (FDA) review for the treatment of patients
suffering from inoperable CTEPH and pulmonary arterial
hypertension (PAH). The candidate is enjoying priority review
process in the US. A final decision from the US regulatory body
is expected by Oct 2013.
Bayer is also seeking EU approval of the candidate in the EU
for the same indication. We believe riociguat's approval will
strengthen Bayer's cardiovascular portfolio.
Riociguat is expected to face stiff competition in the PAH
market on approval. The market already has players like
United Therapeutics Corporation
The HealthCare segment received encouraging news recently when
the FDA approved its oncology drug, Xofigo for the treatment of
patients with castration-resistant prostate cancer (CRPC). Xofigo
is also under review in the EU for the same indication.
Bayer presently carries a Zacks Rank #3 (Hold). Other stocks
Alexion Pharmaceuticals Inc.
) currently look more attractive. Alexion carries a Zacks Rank #2
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