Good news flowed in at
) with the U.S. Food and Drug Administration (FDA) approving the
company's Adempas tablets (riociguat). The drug is approved in
the U.S. for the treatment of adults suffering from
persistent/recurrent chronic thromboembolic pulmonary
hypertension (CTEPH) following surgical treatment or inoperable
CTEPH to improve exercise capacity and WHO functional class.
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The drug is also approved for the treatment of adults suffering
from pulmonary arterial hypertension (PAH) to improve exercise
capacity, improve WHO functional as well as delay clinical
worsening. Adempas is already approved in Canada for the CTEPH
Last month, the U.S. regulatory body granted two separate orphan
drug designations to Adempas for the treatment of PAH as well as
Bayer mentioned in its press release that Adempas is now the only
approved drug in the U.S. for the treatment of two types of
pulmonary hypertension. The drug is also the only U.S. approved
treatment for CTEPH that is inoperable or persistent/recurrent
after surgical treatment.
Adempas' approval in the U.S. 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
remind investors that Bayer is also seeking EU and Japanese
approval of the drug.
We believe the Adempas 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 good news coming from Bayer's
HealthCare segment in recent times. We expect the segment to
continue to drive growth at the company in the coming years.
Bayer, a large-cap pharma company, presently carries a Zacks Rank
#2 (Buy). Meanwhile,
) looks more attractive in the large-cap pharma space with a
Zacks Rank #1 (Strong Buy).