The HealthCare segment of Bayer (BAYRY - Free Report) recently announced positive results from an interim analysis of the phase III PATENT-2 trial on its pipeline candidate riociguat. PATENT-2, the long-term extension phase III study of PATENT-1, evaluated patients suffering from pulmonary arterial hypertension (PAH).
Results from the interim analysis revealed that riociguat was generally well tolerated along with a good long-term safety profile in patients (both treatment-naïve and pre-treated) with PAH. Moreover, improvements were also observed in the six minute walking distance (6MWD) with riociguat treatment.
In Feb 2013, Bayer filed for regulatory approval of riociguat, both in the US and the EU, for the treatment of patients suffering from PAH. The candidate enjoys priority review in the US. A final decision from the US regulatory body is expected by Oct 2013.
The submission was supported by positive results from the PATENT-1 STUDY. Bayer enrolled patients suffering from naïve symptomatic PAH as well as those pre-treated with endothelin receptor antagonists (ERAs) or non-intravenous prostanoid monotherapy, for the study. The study showed a statistically significant improvement in the six-minute walk test from base line after 12 weeks compared to placebo.
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 - Free Report) and Actelion Ltd. (ALIOF - Free Report) .
Moreover, Bayer is seeking US approval of riociguat for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). The candidate is under priority review for the indication in the US. Bayer is seeking approval of the candidate in the EU and Japan as well for the same indication.
Bayer presently carries a Zacks Rank #4 (Sell). Other stocks like Alexion Pharmaceuticals Inc. (ALXN - Free Report) currently look more attractive. Alexion carries a Zacks Rank #2 (Buy).