Bayer (BAYRY - Free Report) recently submitted applications to the US and the EU authorities for the approval of riociguat. 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).
Bayer’s submission for the approval of riociguat was supported by positive results from two global phase III studies - CHEST-1 and PATENT-1. Both studies met their primary objectives. Riociguat was generally well tolerated in patients suffering from PAH and CTEPH in both these studies with no unexpected adverse effects being reported.
The CHEST-1 study enrolled patients suffering from inoperable CTEPH and those suffering from persistent or recurrent disease after a surgical procedure called pulmonary endarterectomy (PEA). A statistically significant improvement was noticed in the study in the six-minute walk test from base line after 16 weeks compared to that of placebo. We note that riociguat is the first candidate to demonstrate clinical efficacy in a placebo controlled phase III study in patients suffering from inoperable CTEPH.
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 PATENT-1 study. The study showed a statistically significant improvement in the six-minute walk test from base line after 12 weeks compared to placebo.
We note that the PAH market is very competitive with the presence of players like Gilead Sciences Inc. (GILD - Free Report) and GlaxoSmithKline plc (GSK - Free Report) .
We believe riociguat’s approval will strengthen Bayer’s cardiovascular portfolio. Bayer currently carries a Zacks Rank #2 (Buy). Another large-cap pharma stock Sanofi (SNY - Free Report) also carries a comparable rank.