The Ministry of Health, Labour and Welfare (MHLW) in Japan
) Adempas for the treatment of adults suffering from inoperable
chronic-thromboembolic pulmonary hypertension (CTEPH) or
persistent or recurrent CTEPH after surgery. Bayer mentioned in
its press release that Adempas is the first drug to be approved
in Japan for the treatment of CTEPH.
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The Japanese approval of Adempas was gained on the basis of final
data from the placebo-controlled pivotal, global phase III
CHEST-1 study and interim results from the long-term CHEST-2
extension study. Results from the CHEST-1 study demonstrated that
after 16 weeks, Adempas showed a statistically significant
improvement from baseline in the six-minute walk test compared to
placebo. Adempas was also well tolerated during the study. The
benefits associated with Adempas treatment, as revealed by the
CHEST-1 study, are backed by interim results from the CHEST-2
study, which is underway.
We remind investors that the drug is already approved in the
U.S., Canada and Switzerland for the CTEPH indication and is
under review in the EU. Adempas is also approved for the
treatment of pulmonary arterial hypertension (PAH) in the U.S.
and is under review in the EU for the same.
We believe the approval of Adempas has strengthened Bayer's
cardiovascular portfolio. We expect the segment to continue to
drive growth at the company in the coming years. However, the
pulmonary hypertension market looks extremely competitive with
the presence of companies like
Gilead Sciences Inc.
Bayer, a large-cap pharma company, carries a Zacks Rank #3
(Hold). Some better-ranked stocks in the large-cap pharma sector
). The stock carries a Zacks Rank #2 (Buy).