Bayer initiates Ph III trail of Xarelto in cardiac event prevention; R&D day presentation

German drug major Bayer (BAYN: DE) has initiated the Phase III COMPASS study of its oral anticoagulant Xarelto (rivaroxaban) for investigating the secondary prevention of major adverse cardiac events including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or peripheral artery disease. The study expects to enroll about 20,000 patients in more than 450 sites across >25 countries worldwide.

Rivaroxaban is the first novel oral anticoagulant under assessment in this high risk patient population. Analysts at Credit Suisse put a net present value to Bayer of 6.20 euros per share for Xarelto across all indications (6% of total for the group). Bayer’s shares rose 0.8% to 66.66 euros in early morning trading, ahead of its annual R&D day taking place at its Leverkusen headquarters (briefly reported below).

“Today, aspirin is the gold standard and provides significant protection for patients with coronary or peripheral artery disease. However, a residual risk of cardiac events such as heart attack, stroke or even death remains in these high-risk patients,” said Salim Yusuf, executive director of the PHRI, Canada, and principal investigator of the COMPASS study, adding: “This is therefore an important study, designed to provide significant insights on additional, potentially complementary, cardioprotective benefits of rivaroxaban for these patients.”