Japanese Approval for Eliquis

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Recently, Bristol-Myers Squibb Company (BMY) and partner Pfizer Inc. (PFE) received some encouraging news with the Japanese Ministry of Health, Labor and Welfare (:MHLW) clearing their anti-clotting drug Eliquis (apixaban) in Japan.

Eliquis was approved in Japan for preventing strokes and systemic embolism in patients suffering from nonvalvular atrial fibrillation (NVAFF). Atrial fibrillation refers to a cardiac rhythm disorder characterized by an erratic heartbeat. Bristol-Myers stated in its press release that AF patients are five times more likely to suffer a stroke compared to non AF patients. The company further stated that one-fifth of all strokes in Japan is due to AF.

We remind investors that the Japanese approval for the indication was sought late last year. The approval by the MHLW was based on data from a phase III study (:ARISTOTLE). The study evaluated 18,201 patients suffering from NVAF, out of which 336 were from Japan. The approval in Japan marks the third approval of the drug for the NVAF indication. The drug was cleared for the NVAF indication in the EU and Canada earlier in the year.

We note that the US approval process of Eliquis for the NVAF indication is on track. The US Food and Drug Administration (:FDA) is expected to decide on whether to approve Eliquis for the indication by March 17, 2013. Positive news from the FDA would boost the sales potential of the drug.

Neutral on Bristol-Myers/Pfizer

Currently, we have a long-term Neutral recommendation on Bristol-Myers. The stock carries a Zacks #3 Rank (Hold) in the short run. We have a similar stance on Pfizer. Large-cap pharma companies that currently look better-positioned include Novo Nordisk (NVO). Novo Nordisk carries a Zacks #2 Rank (Buy).

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