) Healthcare unit and its partner
Johnson & Johnson
) recently initiated a phase III study (COMMANDER-HF) on Xarelto
(rivaroxaban) in patients suffering from heart failure (HF) and
significant coronary artery disease (CAD).
Xarelto is marketed by Johnson & Johnson in the US and by
Bayer outside the US.
Bayer will be evaluating the safety and efficacy of Xarelto in
reducing the risk of death, myocardial infarction (MI) or stroke,
in comparison to placebo. The company will enroll 5,000 patients
suffering from chronic HF and significant CAD following
hospitalization, for the study.
The US Food and Drug Administration (FDA) has already granted
fast track designation for this indication of Xarelto.
Bayer also initiated a phase IIIb (PIONEER AF-PCI) study on
Xarelto for the treatment of patients suffering from non-valvular
atrial fibrillation (AF) who underwent percutaneous coronary
intervention (PCI) with stent placement. The company is expected
to enroll around 2,100 patients for the study worldwide.
We note that Bayer and Johnson & Johnson received a huge
setback recently with the FDA issuing a second complete response
letter (CRL) for the supplemental New Drug Application (sNDA) for
Xarelto (2.5 mg twice daily) for the reduction of the risk of
secondary cardiovascular events in patients suffering from acute
coronary syndrome (ACS). Bayer is currently evaluating the CRL
with Johnson & Johnson and intends to respond to the US
regulatory authority soon.
We note that Xarelto is already approved for several
indications in the US including stroke prevention in nonvalvular
atrial fibrillation, deep vein thrombosis (DVT), pulmonary
embolism (PE) and reducing the risk of recurrent DVT and PE. The
drug performed impressively last year. In 2012, Xarelto sales
increased 265.9% year over year to €322 million (approximately
Bayer, a large cap pharma company, currently carries a Zacks
Rank #3 (Hold). Meanwhile, other large cap pharma stocks such as
Eli Lilly and Company
) are bettered positioned carrying a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
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