Biotech Values

[DewDiligence]

JNJ/Bayer start five phase-3 Xarelto trials in new indications:

http://finance.yahoo.com/news/janssen-launches-explorer-global-cardiovascular-123000178.html

• COMMANDER-HF will evaluate XARELTO in patients with chronic heart failure and significant coronary artery disease who are receiving standard care. The study will include 5,000 patients in 12 countries.

• COMPASS will evaluate XARELTO in patients with coronary artery disease or peripheral artery disease. This study includes 20,000 patients [!] across 25 countries and will be conducted in collaboration with the Population Health Research Institute (PHRI) at McMaster University in Hamilton, Canada.

• PIONEER AF-PCI will evaluate XARELTO in 2,100 patients who have non-valvular atrial fibrillation and are undergoing percutaneous coronary intervention (PCI) with stent placement. The trial will assess XARELTO® in combination with dual antiplatelet therapy and when aspirin is not used.

• X-VeRT will evaluate patients with atrial fibrillation scheduled for cardioversion – a medical procedure to convert abnormally fast heart rate to a normal rhythm, using electricity or antiarrhythmic medications. The study includes 1,500 patients across 17 countries and will compare XARELTO to dose-adjusted vitamin K antagonist [i.e. warfarin].

• VENTURE-AF will evaluate the use of XARELTO in patients with non-valvular atrial fibrillation undergoing catheter ablation, a procedure that uses energy delivered through catheters to eliminate the abnormal tissue that is causing the arrhythmia. The study will include up to 250 patients in four countries.

The three bottomost trials are fairly straightforward attempts to expand Xarelto’s main indication of stroke prevention in patients with AF. The PIONEER study is sort of a back-door attempt to get approval in a segment of the ACS population despite the FDA’s two rejections of the Xarelto NDA for ACS per se (#msg-85274478).

The big news in this PR is the start of the COMMANDER-HF and (especially) the X-VeRT studies, which can be characterized as high-risk/high-reward.