The HealthCare Segment at
) has been the key revenue generator at the company for the last
few years. The cardiovascular portfolio is one of the important
constituents of the segment. Bayer has several products and
candidates in its cardiovascular portfolio including riociguat.
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Last week, the U.S. Food and Drug Administration (FDA) granted
two separate orphan drug designations to riociguat for the
treatment of pulmonary arterial hypertension (PAH) as well as
chronic thromboembolic pulmonary hypertension (CTEPH). In Feb
2013, Bayer submitted a New Drug Application (NDA) for both the
indications of riociguat in the U.S.
We note that the FDA grants orphan drug designation to those
drugs that are meant for treating rare diseases affecting not
more than 200,000 people in the U.S. Riociguat enjoys priority
review designation in the U.S. A final decision from the U.S.
regulatory body on the approval of the candidate is expected
Bayer is also seeking to market riociguat in the EU for the same
indications. We remind investors that riociguat (trade name:
Adempas) was approved in Canada last month for the treatment of
CTEPH after surgery in adults with WHO Functional Class II or III
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 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
) appears to be more attractive in the large cap pharma space
with a Zacks Rank #1 (Strong Buy). Actelion also carries a Zacks