Amarin Raises $100M Debt Funding As It Preps For Vascepa Launch
This article was originally published in The Pink Sheet Daily
With no partner or buyer ready to complete a transaction, Amarin prepares to market an approved fish-oil pill on its own. A new hybrid debt vehicle will tide it over until it receives more clarity around an NCE designation and a second indication, which it hopes could eventually lead to a deal.
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Decreasing cardiovascular events is the only endpoint that matters for cholesterol-lowering drugs, FDA official says at Amarin’s negative Vascepa panel, leaving little room for drug’s expanded approval based on a surrogate endpoint.
A broader indication needs cardiovascular outcomes data, FDA’s advisory committee says, and the agency seems to agree that new cholesterol-lowering drugs need stronger endpoints.
FDA advisors will discuss Oct. 16 whether Vascepa’s effect on reducing triglycerides is enough to overcome concerns about this surrogate endpoint not panning out in other drug’s clinical outcomes trials.