The US Food and Drug Administration (FDA) recently issued a warning regarding the safety of Bristol-Myers Squibb Company’s (BMY) leukemia drug Sprycel. Sprycel is indicated for treating certain adults suffering from Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). The drug, which has treated approximately 32,882 patients since launch, blocks the action of an abnormal protein that causes tumor growth.

The US regulatory body stated that treatment with the drug may elevate the risk of high blood pressure in the lungs’ arteries. The disorder is referred to as pulmonary arterial hypertension (PAH). The FDA stated that due to high blood pressure the heart has to work harder to pump sufficient blood through the lungs. Consequently, the heart muscles stand the risk of becoming weak which may cause them to loose the ability to perform the above function. Breathlessness, fatigue and swelling of body parts (such as the ankles and legs) are the common symptoms associated with PAH.

The FDA asked the doctors to assess patients for symptoms of cardiopulmonary disease not only prior to prescribing Sprycel but also during treatment. The FDA stated that treatment with Sprycel should be discontinued permanently in the event of PAH being confirmed. The US regulatory body asked the leukemia patients undergoing Sprycel therapy to contact the doctor immediately on developing PAH symptoms.

The FDA warning followed twelve confirmed cases of PAH associated with Sprycel therapy. However, none of the affected patients died. The patients, affected by PAH, were taking Sprycel for more than a year. The label of the drug has been suitably amended to include the warning issued by the FDA.

Our Recommendation

We have a Neutral stance on Bristol-Myers. Our biggest concern regarding the company is the high exposure to generic risk on many of its leading drugs including the blockbuster blood thinner Plavix. Bristol-Myers has co-developed Plavix with Sanofi-Aventis (SNY). Bristol-Myers has been looking to expand via acquisitions and partnership deals to counter the loss of revenues that would arise following the genericization of its key drugs. The stock carries a Zacks #2 Rank (Buy rating) in the short run.


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