The European Committee for Medicinal Products for Human Use
(CHMP) has issued a positive opinion on the approval of
) riociguat in two forms of pulmonary hypertension.
Bayer is looking to get riociguat approved in the EU for the
treatment of persistent/recurrent chronic thromboembolic
pulmonary hypertension (CTEPH) following surgical treatment or
inoperable CTEPH to improve exercise capacity. The company is
also looking to get riociguat approved for the treatment of
adults suffering from pulmonary arterial hypertension (PAH) to
improve exercise capacity.
A final decision from the European Commission on the approval of
riociguat is expected by Jun 30, 2014. The regulatory submission
in the EU for riociguat for both the indications was made in Feb
The CHMP's opinion on riociguat was based on positive results
from two global phase III studies − CHEST-1 and PATENT-1. Both
studies met their primary objectives. Riociguat was generally
well tolerated in patients suffering from PAH and CTEPH in both
these studies with no unexpected adverse effects being reported.
We note that riociguat is already approved in the U.S. under the
trade name Adempas for both the indications. Adempas is also
approved in Japan, Canada and Switzerland for the CTEPH
We believe riociguat's approval in the U.S. and EU will
strengthen Bayer's cardiovascular portfolio. However, the
pulmonary hypertension market looks extremely competitive with
the presence of companies like
Gilead Sciences Inc.
We are encouraged by the string of positive news from Bayer's
HealthCare segment over the last few quarters. We expect the
segment to continue to drive growth at the company in the coming
Bayer, a large-cap pharma company, presently carries a Zacks Rank
#3 (Hold). A better-ranked stock in the large-cap pharma sector
). The stock carries a Zacks Rank #2 (Buy).
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