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The baseball playoffs aren't the only three-game home stands going on right now. The FDA advisory committee is voting on whether to recommend drugs from three development-stage biotechs. Let's see where we stand after Day Two.
But first let's recap Day One's action, where NPS Pharmaceuticals (Nasdaq: NPSP ) won a commanding 12-0 unanimous vote in favor of its short bowel syndrome drug Gattex. This is NPS's lead drug candidate, and FDA staff indicated there wouldn't need to be restricted access to Gattex. The drug allows patients who require daily intravenous nutrients to go as many as three days without, greatly improving quality of life. NPS was down on the vote, but it rose nearly 20% at the end of last week, when the briefing documents were released.
Today's results also came with nearly as big a thumbs-up from the advisory committee. Aegerion (Nasdaq: AEGR ) claimed a 13-2 victory for its homozygous familial hypercholesterolemia (HoFH) drug lomitapide. This is a condition that affects only a small number in the U.S., but it is deadly serious. HoFH impairs liver function, causing early heart attacks from uncleared cholesterol. There were safety issues -- namely liver disease -- to go along with the drug's strong efficacy, but that was not enough to deter the panelists. Now because of the safety concerns, I think the FDA will look at this with scrutiny, especially with regard to its use outside the rare genetic disorder, but its unmet need should help it get approved. The questions remain how restricted access to the drug will be.
And tomorrow we have ISIS Pharmaceuticals (Nasdaq: ISIS ) also treating HoFH, but with a different class of drug. Unfortunately for ISIS, Kynamro's safety profile regarding liver problems is also troubling, plus it has the added problem of negative injection site reactions. The company is seeking a broader patient population suffering from a variety of high-cholesterol-related diseases, which is precisely the red flag the advisory committee waved emphatically today. That helps explain why shares of ISIS traded 6% lower as the day's events unfolded, and this follows a 20% decline after the briefing documents were released, showing the FDA's concerns over Kynamro. I suspect that despite the added credibility of having Sanofi (NYSE: SNY ) as I partner, ISIS will just squeak by tomorrow, but with similar access concerns and a much narrower margin of victory.
With final FDA decisions coming before the end of 2012, all three companies will be at the forefront of investors' minds and deserve close watching. How the FDA restricts access could dramatically affect their chances of reaping sizable profits.
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