The HealthCare segment at Bayer (BAYRY) 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 Pfizer Inc.’s (PFE) 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 Actelion Ltd. (ALIOF) and Allergan Inc. (AGN). While Actelion holds a Zacks Rank #1 (Strong Buy), Allergan carries a Zacks Rank #2 (Buy).