The FDA's documents on AstraZeneca's (NYSE: AZN) Brilinta were far from brilliant for the drugmaker. Still, investors knew tomorrow's advisory committee meeting was going to be tough, and seem to have seen more good than bad when they sent the drugmaker up nearly 4% yesterday.
The overall data for Brilinta are fairly clear. The drug works better than Bristol-Myers Squibb (NYSE: BMY) and sanofi-aventis' (NYSE: SNY) Plavix in preventing heart attacks and strokes. But the data from clinical trial patients in the U.S. were troublesome, with U.S. patients experiencing a worse outcome than those seen abroad.
Tomorrow, the FDA will ask the panel of outside experts if they think the disparity was due to chance or some other factor that's unique to the U.S. -- a higher level of aspirin being prescribed, for instance. Doctors could then theoretically stop that practice to get results similar to those outside the U.S. Of course, the only way to know for sure would be to run another large clinical trial testing the hypothesis. One suggestion is that the study could be done after approval, which might be the reason for the excitement yesterday.
Even if AstraZeneca gets past the advisory committee tomorrow, and then the FDA by mid-September, it's still going to be an uphill battle for the company. Eli Lilly's (NYSE: LLY) Effient also beat Plavix in a head-to-head trial, but Effient hasn't been able to beat the multibillion-dollar drug in the marketplace. It hasn't even come close. Dethroning a drug that doctors have been prescribing for years is tough, and it won't get any easier when cheap generic versions of Plavix hit the market shortly.
AstraZeneca needs a blockbuster to deal with looming patent expirations, but I don't think Brilinta is the gleaming light that's going to save the British drugmaker.
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