(UTHR) Bayer Files Riociguat in Japan

The HealthCare segment of Bayer (BAYRY) recently submitted a regulatory application for its chronic thromboembolic pulmonary hypertension (CTEPH) candidate, riociguat, in Japan.

Bayer mentioned in its press release that riociguat is the first candidate to demonstrate clinical efficacy in the treatment of inoperable CTEPH patients or patients suffering from persistent or recurrent CTEPH after surgery. The regulatory submission of riociguat was on the basis of positive results from the placebo-controlled pivotal, global phase III CHEST-1 study.

Results from the study revealed that after 16 weeks, riociguat showed a statistically significant improvement from baseline in the six-minute walk test compared to placebo. Riociguat was also well tolerated during the study.

We note that riociguat is currently under the US Food and Drug Administration (FDA) review for the treatment of patients suffering from inoperable CTEPH and pulmonary arterial hypertension (PAH). The candidate is enjoying priority review process in the US. A final decision from the US regulatory body is expected by Oct 2013.

Bayer is also seeking EU approval of the candidate in the EU for the same indication. We believe riociguat’s approval will strengthen Bayer’s cardiovascular portfolio.

Riociguat is expected to face stiff competition in the PAH market on approval. The market already has players like United Therapeutics Corporation (UTHR) and Actelion Ltd. (ALIOF).

The HealthCare segment received encouraging news recently when the FDA approved its oncology drug, Xofigo for the treatment of patients with castration-resistant prostate cancer (CRPC). Xofigo is also under review in the EU for the same indication.

Bayer presently carries a Zacks Rank #3 (Hold). Other stocks like Alexion Pharmaceuticals Inc. (ALXN) currently look more attractive. Alexion carries a Zacks Rank #2 (Buy).

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