UPDATED: FDA experts vote against expansion of Amarin's Vascepa

Members of an FDA advisory panel are overwhelmingly against extending the use of Amarin's fish-oil drug Vascepa with a cholesterol-lowering statin to reduce the risk of coronary disease. It is not that it doesn't reduce the high lipids it targets; panel members were just not convinced that doing so will prevent users from getting the potentially fatal disease.

Shares of the Irish company were not traded Wednesday as the meeting was being held but tanked on Thursday, falling more than 60% in mid-morning trading as investors bailed out of the stock. That was after the stock was already down more than 50% over the last 12 months, as the company was unable to attract a partner or garner much interest in the fish-oil drug.

According to Reuters, the panel voted 9-2 Wednesday against the expanded use for the drug, which is already approved to reduce very high triglycerides in adults. The decision comes on top of skepticism expressed by FDA staffers Friday regarding whether data from a trial on heart risks should be provided before an expanded use is given. That data is not expected until 2016, and the FDA was expected to rule this year on the application. The U.S. authority doesn't have to take the recommendation, but often it does.

Analysts initially thought Vascepa could be a blockbuster, particularly if it could get an expanded use. But the Irish drugmaker has been unable to get any traction with it. When no potential partners came forward after it got approval last year, the Irish company borrowed $100 million to pay for the drug's launch. Vascepa competes with GlaxoSmithKline's ($GSK) fish oil pill Lovaza, which was approved in 2004, also for patients with very high triglycerides. Lovaza had sales of £607 million ($968 million) last year. Vascepa had sales last quarter of $5.5 million.

In the meantime, a federal court ruling has paved the way for generics of Lovaza from Par Pharmaceuticals and Teva Pharmaceutical Industries ($TEVA). When that ruling came out last month, it was Amarin's shares that suffered the most.

- read the Reuters story

Related Articles:
FDA staff report puts hurt on Amarin
Ruling against GSK's Lovaza fish-oil pill puts hurt on competitor Amarin
Amarin's fish oil future gets slippery with $100 million in debt
Amarin asks FDA to approve Novasep as Vascepa partner

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