Recently, Bristol-Myers Squibb Co. (BMY) and partner Pfizer Inc. (PFE) announced that a late-stage study evaluating their anti-clotting drug apixaban in patients with atrial fibrillation will be stopped. The two companies agreed to develop and commercialize apixaban via an agreement signed in 2007.
Atrial fibrillation (AF) refers to a particular type of heartbeat (arrhythmia) characterized by an extremely fast irregular rhythm. AF causes blood to pool in an upper chamber of the heart and increases the risk of blood clots and stroke.
The decision to stop the study, which was conducted to compare the ability of apixaban and aspirin to prevent stroke, emanated from a predefined interim analysis by the independent data monitoring committee. The analysis demonstrated clear evidence that apixaban prevented stroke among patients with atrial fibrillation. Furthermore, the analysis revealed an acceptable safety profile for apixaban compared to aspirin.
The late-stage study, known as AVERROES (Apixaban Versus Acetylsalicylic Acid to Prevent Strokes), evaluated 5,600 patients suffering from atrial fibrillation. The study was conducted in 36 countries across the globe. The subjects were unsuitable for treatment with warfarin (the current standard of care). Aspirin is often used to help prevent blood clots in such patients but its efficacy is much lower than warfarin.
Following the decision to halt the study, the two companies are working to close the study and ensure that patients are informed of the opportunity to start treatment with apixaban in an open-label extension.
The shares of both the companies rose following the decision to halt the study because of signals of increased efficacy of the anti-clotting drug.
Our Take
Even though patent expirations loom large on Bristol in the near future, we believe the company has taken some measures – like the Medarex acquisition, among others – to counter the loss of revenues resulting from the patent expirations of its key drugs.
The company intends to launch five compounds – apixaban, belatacept, brivanib, dapagliflozin and ipilimumab – by 2012. The new launches are expected to drive growth in 2013 and beyond.
Currently we are Neutral on Bristol-Myers as well as Pfizer. Our Neutral stance on the companies indicates that the stocks are expected to perform in line with the
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