The HealthCare segment of
) recently announced positive results from an interim analysis of
the phase III PATENT-2 trial on its pipeline candidate riociguat.
PATENT-2, the long-term extension phase III study of PATENT-1,
evaluated patients suffering from pulmonary arterial hypertension
Results from the interim analysis revealed that riociguat was
generally well tolerated along with a good long-term safety
profile in patients (both treatment-naïve and pre-treated) with
PAH. Moreover, improvements were also observed in the six minute
walking distance (6MWD) with riociguat treatment.
In Feb 2013, Bayer filed for regulatory approval of riociguat,
both in the US and the EU, for the treatment of patients
suffering from PAH. The candidate enjoys priority review in the
US. A final decision from the US regulatory body is expected by
The submission was supported by positive results from the
PATENT-1 STUDY. Bayer enrolled patients suffering from naïve
symptomatic PAH as well as those pre-treated with endothelin
receptor antagonists (ERAs) or non-intravenous prostanoid
monotherapy, for the study. The study showed a statistically
significant improvement in the six-minute walk test from base
line after 12 weeks compared to placebo.
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
United Therapeutics Corporation
Moreover, Bayer is seeking US approval of riociguat for the
treatment of chronic thromboembolic pulmonary hypertension
(CTEPH). The candidate is under priority review for the
indication in the US. Bayer is seeking approval of the candidate
in the EU and Japan as well for the same indication.
Bayer presently carries a Zacks Rank #4 (Sell). Other stocks
Alexion Pharmaceuticals Inc.
) currently look more attractive. Alexion carries a Zacks Rank #2
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