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Latest in Stroke-Prevention Saga: FDA Panel Backs Drug From J&J and Bayer

Xconomy New York — 

Yesterday I wrote about apixaban (Eliquis), a drug that Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) are developing to prevent strokes in patients with the heart-rhythm disorder atrial fibrillation. The folks at Bristol were paying close attention to a meeting at the FDA yesterday, during which an advisory panel to the agency voted on whether it should approve a stroke-prevention drug developed by Johnson & Johnson (NYSE: JNJ) and Bayer.

After the stock market closed, the panel handed down its verdict—and it was a good one for J&J and Bayer. The panel voted nine-to-two in favor of approval. (There was one abstention.) It was a surprisingly good outcome: Just two days earlier, the FDA posted a scathing review of the drug, rivaroxaban (Xarelto), on the Web. Shares of Bayer, which had dropped 7.5 percent on the Frankfurt exchange on Tuesday, recovered on Friday. J&J shares were unchanged in pre-market trading.

The FDA doesn’t have to follow the advice of its panels, but it usually does. J&J and Bayer expect to get a decision from the FDA on rivaroxaban in early November. Bristol and Pfizer, meanwhile, expect to file for approval of apixaban by the end of this year, which would mean a potential approval in the second half of next year. Both drugs are in a class known as “factor Xa inhibitors”—they block an enzyme that causes clotting.

What all these Big Pharma players are trying to do is develop alternatives to warfarin, a 60-year-old anti-clotting drug that’s effective and extremely affordable as a generic—but that also presents major challenges for patients. There are about 2.6 million Americans with atrial fibrillation, a condition that causes heart pounding and breathlessness, and that greatly increasesthe risk they’ll suffer strokes. Warfarin lessens that risk by at least two-thirds, says Christopher Granger, a professor of medicine at Duke Clinical Research Institute. “But patients need to be monitored on a regular basis because of the unpredictable nature of warfarin’s effects,” he says. “It interacts with other drugs and food in a way that impacts lifestyle.” And it can cause dangerous and potentially fatal bleeding.

The battle to make warfarin obsolete is most definitely a New York story. Pfizer and Bristol, who teamed up to develop apixaban in 2007, are based in Manhattan. J&J’s sprawling headquarters building is located in nearby New Brunswick, NJ. Even Bayer, which is based in Germany, has a major New York presence—its consumer-products, diabetes, and pharmaceutical units all have offices in the area.

Rivaroxaban is not quite a guaranteed win for J&J and Bayer. Some analysts are predicting the label for the drug may include some restrictions on its marketing. And as yesterday’s enlightening blow-by-blow of the panel discussion by a Forbes blogger shows, the panelists were less-than-enthusiastic about the drug, even as they were voting in favor of approval. “I don’t think anyone has supported a superiority claim” for rivaroxaban over warfarin, the reporter wrote just minutes before the panel discussion ended.

In a statement released after the vote, Peter DiBattiste, global therapeutic area head for J&J’s cardiovascular and metabolism unit, said: “We are pleased with the committee’s recommendation and look forward to working with the FDA to help make this important therapy available in the U.S.”

The J&J/Bayer and Bristol/Pfizer teams won’t just be duking it out against each other and the mainstay warfarin. They’ll also be fighting for market share against dabigatran (Pradaxa), an anti-clotting drug from Boehringer Ingelheim that targets a different protein in the clotting cascade. And Japan’s Daiichi Sankyo is developing its own Factor Xa inhibitor, edoxaban. They’re all grabbing for a piece of a market that could be enormous: Leerink Swann analyst Seamus Fernandez estimates the total market size to be between $3 billion and $5 billion.

Granger has done studies on both apixaban and dabigatran. But he’s hoping all four competitors ultimately make it to the market. “It could only be a good thing for patient care to have more than one option,” he says. “They all have benefits over warfarin.”