) HealthCare segment recently received encouraging news from the
US Food and Drug Administration (FDA) as it granted priority
review designation to the New Drug Application (NDA) for
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). A final decision from the US regulatory body
is expected by Oct 2013.
We note that the US regulatory authority generally reviews
those drugs on a priority basis which offer major advances in
treating diseases having no adequate therapy. Applications for
priority review designated drugs are reviewed by the FDA within
eight months of submission as against the usual twelve
Bayer is also seeking approval of the candidate in the EU for
the same indication.
Approval has been sought on the basis of positive results from
two global phase III studies - CHEST-1 and PATENT-1. Riociguat
was generally well tolerated in patients suffering from PAH and
CTEPH in both these studies with no unexpected adverse
We believe riociguat's approval will strengthen Bayer's
cardiovascular portfolio. Riociguat will face stiff competition
in the PAH market on approval. The market already has players
Gilead Sciences Inc.
We note that Bayer suffered a huge setback last month when the
company and its partner
Johnson & Johnson
) received a second complete response letter (CRL) from the US
Food and Drug Administration (FDA) for their supplemental New
Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for the
reduction of the risk of secondary cardiovascular events in
patients suffering from acute coronary syndrome (ACS).
Bayer, a large cap pharma company, currently carries a Zacks
Rank #4 (Sell). The setback regarding Xarelto is primarily
responsible for the bearish rank carried by the company.
Meanwhile, other large cap companies such as
) currently look better positioned carrying a Zacks Rank #2
(Buy). Gilead also carries a comparable rank.
ALLERGAN INC (AGN): Free Stock Analysis
BAYER A G -ADR (BAYRY): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
To read this article on Zacks.com click here.