Amarin’s (AMRN) cholesterol drug AMR101 for treatment of patients with high triglyceride levels� is likely to be approved by the FDA today, writes Cannacord Genuity analyst Ritu Baral in a note. The FDA’s review period expires today, and analysts have been predicting that the drug will be approved. Baral also expects that the ruling could give AMR101 exclusivity for five years. JP Morgan analysts said this week that the drug could bring in more than $1 billion in sales according to fly on the wall.
“We expect three-year exclusivity will be granted to AMR101 under Hatch- Waxman�s �new clinical investigation� clause. We think there is a good chance FDA may rule AMR101 is a new chemical entity, giving five-year exclusivity,” Baral writes.
Amarin shares are up about 3%.
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