Bayer Cardiovascular Suite Progresses


The HealthCare Segment at Bayer (BAYRY) 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.

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 soon.

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 pulmonary hypertension.

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 Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD).

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 #4 (Sell). Roche (RHHBY) appears to be more attractive in the large cap pharma space with a Zacks Rank #1 (Strong Buy). Actelion also carries a Zacks Rank #1.

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