The HealthCare segment at
) issued a statement regarding its marketed product, Aleve
(naproxen), following a joint meeting of the Arthritis Advisory
Committee (AAC) and Drug Safety Committee and Risk Management
Advisory Committee (DSaRM).
Bayer stated that the U.S. Food and Drug Administration (FDA)
panel did not find any accumulated data to support a significant
difference in cardiovascular risk for Aleve compared to other
non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs). The
FDA advisory panel concluded that Aleve has a low cardiovascular
thrombotic risk profile compared to other non-aspirin NSAIDs.
We note that the label of Aleve is inclusive of a FDA-mandated
cardiovascular warning which states that the risk of heart attack
or stroke may increase if the drug is used more than directed or
for longer than directed.
Bayer now intends to work with the FDA so that appropriate
information on Aleve is communicated to consumers, patients and
healthcare providers. At present other non-aspirin NSAIDs include
) Celebrex and Advil.
Bayer gained over 4% on the encouraging news. Bayer recorded
Aleve sales of €79 million in the third quarter of 2013. We
expect sales of the drug to improve in the coming quarters
supported by the FDA panel's recommendation. Bayer will report
its fourth quarter and full year 2013 results on Feb 28.
Bayer currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
). While Actelion holds a Zacks Rank #1 (Strong Buy),
Allergan carries a Zacks Rank #2 (Buy).
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