It's likely sink-or-swim later this month

Some analysts are predicting a big swing in Bristol-Myers Squibb�s (NYSE:BMY) stock later this month based on upcoming results of a study of the company�s new blood thinner. If the top-line data from the Phase III trial of Bristol�s and Pfizer�s (NYSE:PFE) apixaban are positive, Bristol could get as much as a 5% bump in its share price, says one analyst. If the results are disappointing, the company�s stock could dive by as much as 10%.

The bar apixaban has to clear isn�t all that high: The drug, which is already approved for use in Europe, need only prove to be equal to the longtime industry standard, warafin. If apixaban shows it�s more effective than warafin and has fewer side-effects, the market reaction should be highly positive. If the drugs misses its primary endpoint, Bristol-Myers shareholders will not be pleased, to say the least.

The stakes in the blood-thinner race are high. It�s estimated the market should top $10 billion a year for the host of new drugs being introduced to prevent stroke among patients with atrial fibrillation. The therapies also will be used to prevent blood clots in patients undergoing hip and knee replacements.

Apixaban will likely be the third of a new breed of anticoagulants vying to replace warafin, a 50-year old drug that carries serious bleeding risk, requires frequent dosing adjustments and requires strict diet restrictions. The two others are Boehringer Ingelheim’s Pradaxa, or dabigatran, which is already on the market, and Xarelto, or rivaroxaban, a drug developed by Bayer and Johnson & Johnson (NYSE:JNJ) that is awaiting U.S. approval.
The completion is likely to become even stiffer when a fourth entry called edoxaban from� Daiichi Sankyo eventually joins the fray.

Despite Pradaxa’s healthy headstart in the market and Xarelto’s more convenient once-daily dosing, Bristol and Pfizer have one huge advantage! over th eir rivals: an unparalleled cardiovascular franchise thanks to the success of their respective cholesterol fighter Lipitor and blood clot preventer Plavix — the world’s two biggest-selling medicines.

So even though apixaban will likely be somewhat late to the game, the cardiovascular marketing muscle and reputations of Bristol and Pfizer should enable the companies to gain easy access to prescribers. Moreover, Bristol and Pfizer say apixaban�s twice-daily dosing is actually an advantage because it allows for fewer peaks and valleys of the drug in the system.

One medical consultant said the apixaban stroke reduction rate could be lower than its rivals, but show a lower bleeding risk and still be seen as a success.

With the impending U.S. patent expirations and vastly lower sales for both Lipitor and Plavix, you can be certain executives at both Pfizer and Bristol are keeping their fingers crossed that the apixaban study results will be just what the doctor ordered.

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