Back to top

Analyst Blog

Recently, Bristol-Myers Squibb Company (BMY - Analyst Report) and partner Pfizer Inc. (PFE - Analyst Report) received some encouraging news when the US Food and Drug Administration (FDA) cleared their anti-clotting drug Eliquis (apixaban).

Eliquis was approved in the US for reducing the risk of strokes and systemic embolism in patients suffering from nonvalvular atrial fibrillation (NVAF). Atrial fibrillation refers to a cardiac rhythm disorder characterized by an erratic heartbeat. Bristol-Myers/Pfizer stated that they intend to issue a detailed press release about the approval shortly.

We note that the US approval process of Eliquis was anything but smooth. The companies had initially filed a new drug application (NDA) last year. The NDA included data from two phase III studies, ARISTOTLE and AVERROES. However, after reviewing the NDA, the US regulatory authority declined to approve Eliquis for the NVAF indication on the basis of the submitted data and issued a complete response letter (CRL) in June 2012.

While issuing the CRL, the FDA asked for additional information on data management and verification from the ARISTOTLE study. The FDA was satisfied with the resubmitted NDA and assigned a target date of March 17, 2013. However, the US regulatory body cleared Eliquis a couple of months before the target date.

The US approval of Eliquis for the NVAF indication comes close on the heels of the Japanese approval of the drug for the same indication. Eliquis has also been approved for the NVAF indication in the EU and Canada in 2012.

We note that the anti-coagulant market currently includes Bayer/Johnson & Johnson’s (BAYRY - Analyst Report)/(JNJ - Analyst Report) blood-thinner Xarelto. Moreover, the arrival of Boehringer Ingelheim’s Pradaxa has intensified competition in the market.

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 - Analyst Report). Novo Nordisk carries a Zacks #2 Rank (Buy).
 

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
ERBA DIAGNO… ERB 3.70 +4.23%
BANCO DO BR… BDORY 14.49 +3.87%
WEATHERFORD… WFT 23.71 +3.40%
MALLINCKROD… MNK 78.37 +3.19%
AIR INDUSTR… AIRI 9.89 +3.13%