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Shares of Aegerion Pharmaceuticals (NASDAQ: AEGR ) hit a new 52-week high in intra-day trading on Friday. The company hadn't announced any information about its lead drug lomitapide. But a potential competitor from Isis (NASDAQ: IONS ) and Sanofi (NYSE: SNY ) received a negative recommendation from a European Medicines Agency committee, citing safety concerns. This bump was temporary, but the EMA info adds to past events to spell trouble for Kynamro -- and a potential win for Aegerion.
Lomitapide and Kynamro treat homozygous familial hypercholesterolemia (HoFH) -- or severely high cholesterol. The drugs have run nearly parallel down the pipelines, making an event for one reflect almost immediately upon the other. And the drugs have both proven effective , meaning the final battle panel will play out in the arena of safety.
It's a battle that Kynamro may lose. The drug's latest setback is the EMA committee "nay." Safety concerns aren't surprising; both drugs have faced safety questions along the way. But a Kynamro-specific concern could become the decider.
Both HoFH drugs went before FDA advisory panels in October, appearing on consecutive days. Aegerion was up first, and shares rose 13% upon the approval recommendation, despite concerns about potential liver risks. Kynamro also received a recommendation, but Isis shares fell 20%, due to additional concerns raised by its panel. As the Fool's Sean Williams wrote, the panel detailed Kynamro's risk of abnormal tissue growth that appeared in 3.1% of the trial's patients.
The time for the FDA's decisions is upon us. Aegerion should receive word by the end of this month, and Isis should come in late January . Investors need to keep a close watch on the results of these decisions.
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