FDA staff report puts hurt on Amarin

So what is the difference between a drug approved to treat very high triglycerides and one approved to treat merely high triglycerides? Thirty-six million more potential patients, and, in the case of Amarin's Vascepa, maybe the results of a clinical trial on heart risks.

That was the suggestion that came out of an FDA report posted on the FDA website today in advance of an advisory committee meeting slated for next Wednesday, Bloomberg reports. The company's ($AMRN) Reduce-IT study that would provide those results is not expected to be complete until 2016. Amarin shares fell nearly 8% on news of the report.

Amarin's Vascepa was approved last year to treat patients with very high triglycerides in their blood--levels of 500 mg per deciliter and above. It competes against 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 has the advantage over Lovaza of not raising bad cholesterol levels.

Given that advantage, and with the right partner to market it, Citi Investment Research had forecast that Vascepa could reach peak sales of $2.6 billion. Even without a partner, analysts initially suggested Vascepa could generate $1.5 billion a year for Amarin, but things have yet to play out the way they were predicted.

Vascepa had only $5.5 million in sales in the last quarter, Bloomberg reports. In addition to it being limited to a smaller patient population, the FDA has yet to rule on whether to grant the drug a new chemical entity designation, which would give it longer exclusivity protection. Amarin shares were hammered last month with a federal court ruling that paves a way for a generic of GSK's Lovaza.

The FDA advisory board does not have to go by what FDA staff suggests, and then the FDA itself is not bound by what the advisory panel suggests. The FDA was expected to make its ruling this year, but that timetable has been put into question by the government shutdown.

- read the Bloomberg story
- here's the FDA post (PDF)