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

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the 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.”

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