The Ministry of Health, Labour and Welfare (:MHLW) in Japan approved Bayer’s (OTC:BAYRY) 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.
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 Actelion Ltd. (OTC:ALIOF) and Gilead Sciences Inc. (NASD:GILD).
Bayer, a large-cap pharma company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the large-cap pharma sector include Allergan (NYSE:AGN). The stock carries a Zacks Rank #2 (Buy).
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