) recently submitted applications to the US and the EU
authorities for the approval of riociguat. Bayer is looking to
get riociguat approved for the treatment of patients suffering
from inoperable chronic thromboembolic pulmonary hypertension
(CTEPH) and pulmonary arterial hypertension (PAH).
Bayer's submission for the approval of riociguat was supported
by 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.
The CHEST-1 study enrolled patients suffering from inoperable
CTEPH and those suffering from persistent or recurrent disease
after a surgical procedure called pulmonary endarterectomy (PEA).
A statistically significant improvement was noticed in the study
in the six-minute walk test from base line after 16 weeks
compared to that of placebo. We note that riociguat is the first
candidate to demonstrate clinical efficacy in a placebo
controlled phase III study in patients suffering from inoperable
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
PATENT-1 study. The study showed a statistically significant
improvement in the six-minute walk test from base line after 12
weeks compared to placebo.
We note that the PAH market is very competitive with the
presence of players like
Gilead Sciences Inc.
We believe riociguat's approval will strengthen Bayer's
cardiovascular portfolio. Bayer currently carries a Zacks Rank #2
(Buy). Another large-cap pharma stock
) also carries a comparable rank.
BAYER A G -ADR (BAYRY): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
GLAXOSMITHKLINE (GSK): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.