Bristol-Myers, Pfizer's Eliquis approved in Japan

Published on NewsOK Modified: December 26, 2012 at 12:56 pm •  Published: December 26, 2012
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The FDA originally was to decide whether to approve Eliquis last March, but said it needed more time to review new data. In June, the FDA said it couldn't approve the drug until the companies provided more information on "data management and verification" from a huge international study called ARISTOTLE. That was submitted in September. The FDA is scheduled to rule by March 17.

Approval in Japan, the world's second-biggest market for prescription drugs after the U.S., will boost sales of Eliquis, but U.S. sales are needed to reach blockbuster status — annual sales of more than $1 billion.

The makers of all three drugs must persuade doctors and consumers that their pill is the most effective and safest, and that it's worth the extra cost. Xarelto and Pradaxa both cost roughly $250 per month. Pfizer and Bristol-Myers have not disclosed a price for Eliquis. Warfarin typically costs less than $10 per month, plus at least $1,600 a year for frequent tests of its level in the blood.

Johnson & Johnson has not has not yet reported sales figures for Xarelto. However, partner Bayer reported Xarelto sales totaling about $235 million in the first nine months of this year. Boehringer Ingelheim reported Pradaxa sales of about $615 million worldwide in the first half of 2012.

In afternoon trading, shares of Bristol-Myers were down 12 cents at $32.34, and Pfizer shares were up 11 cents at $25.19.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma.