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Pfizer, Bristol-Myers Dealt Approval Setback on Blood Thinner Eliquis


The FDA says the drug isn't ready to hit the market for stroke prevention. An analyst predicts approval within a year.

MINYANVILLE ORIGINAL A new stroke-prevention drug developed by Bristol-Myers Squibb (BMY) and Pfizer (PFE) isn't ready for US approval, according to the Food and Drug Administration. That unexpected development doesn't sink the big drug companies' plans for a new blockbuster product but it certainly delays them.

Shares of Bristol-Myers fell almost 4% to $34.03 in trading Monday morning. The stock is still up 3% over the past three months. Pfizer fell more than 1% to $22.44. The company's shares also gained about 3% in the last three months.

Investors want promising new products from big drug makers who are trying to replace multi-billion dollar medicines at the end of their patent lives. The blood-thinning drug Eliquis generated a lot of excitement as it appeared to show in company studies that it worked far better than warfarin, the standard of care for decades.

Two other anti-clotting drugs have hit the US market in the last couple of years, Johnson & Johnson (JNJ) and Bayer's (BAYRY) Xarelto and Boehringer Ingelheim's Pradaxa. However, many investors feel that Eliquis is a superior drug that can be a leader among the new group of treatments, ISI Group analyst Mark Schoenebaum says.

Schoenebaum says he believes Eliquis will be approved no later than July of next year because he doesn't see a major hurdle to satisfying the FDA, which wants more documentation on one of the human studies for the drug. The FDA wants more proof of Eliquis' effectiveness and safety. While the companies aren't saying much at this point, Schoenebaum notes the wording from their press release Monday morning has a note of optimism: "The FDA has not requested that the companies complete any new studies," the companies say in their statement. "FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward."

The reason investors should be excited about this drug, Schoenebaum says, is because studies show Eliquis is more effective than warfarin and is far safer. A risk of taking these drugs is severe bleeding, and Eliquis was shown in clinical studies to be superior than warfarin by that measure.

"That was a huge upside surprise and was unprecedented in the history of these novel blood thinners," Schoenebaum says. He estimates that hope for Eliquis represents about 10% of the value of Bristol-Myers.

If the drug is approved, the companies will split the US profits in half. Analysts predict the drug can eventually be a multi-billion dollar seller.

The Eliquis decision follows news last week that J&J's Xarelto failed to win approval for expanded use. Xarelto is approved for stroke prevention in people with a history of irregular heartbeats and to treat blood clots in patients who have hip or knee replacements. J&J and Bayer sought to win approval for prevention of heart attacks and strokes for people with a history of heart problems. That rejection was expected following a negative recommendation from government advisers who reviewed Xarelto for the additional indication. (See Johnson & Johnson Setback Is Positive for Pfizer, Bristol-Myers.)

Twitter: @brettchase

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