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Is Amarin’s Fish Oil Blockbuster Dream Kaput?

File this under ‘best of luck.’ One week after the FDA rescinded a special protocol agreement that Amarin (AMRN) was counting on to significantly widen usage for its Vascepa prescription fish oil pill, the drug maker has filed an appeal (see page 18 of SEC filing).

Whether the agency will change its collective mind is unclear, but a reversal is likely to be a long shot, at best.

AMRN Market Cap Chart

AMRN Market Cap data by YCharts

The effort is the latest twist in what has been one of the more closely watched biopharma stock stories on Wall Street this year. Investors were captivated by the possibility that the drug maker might have been able to market a potential blockbuster amid a heated debate over the virtue of using lower triglycerides as a predictive metric for lowering cardiovascular risks.

As we reported previously, Vascepa is already approved for treating people with very high triglyceride levels, or more than 500 mg/dL, which is approximately 4 million people in the US. Amarin, however, had sought FDA approval to market Vascepa to people with high cholesterol and high triglycerides, which is between 200 and 500 mg/dL, a market that is estimated to be as many as 36 million people.

The Vascepa approval had been based on a trial called Anchor that was the basis for the special protocol agreement, and Amarin hoped to steal market share from Lovaza, a $1 billion seller for GlaxoSmithKline (GSK). If the clinical effect of combining Vascepa and a statin were to prove beneficial to cardiovascular outcomes, then a drug maker that inks a deal with - or acquires - Amarin would have a blockbuster. (For GlaxoSmithKline, which has suffered outright revenue declines in recent years, a development that protects Lovaza is welcome news.)

GSK Revenue (TTM) Chart

GSK Revenue (TTM) data by YCharts

Last month, though, Amarin appeared to hit a brick wall. An FDA advisory committee voted 9-to-2 against recommending broader use until an outcomes study is completed in 2016, prompting the FDA to rescind the special protocol agreement. Amarin has since cut its staff by 50 percent and now faces a growing number of shareholder lawsuits that accuse the drugmaker of making overly optimistic predictions. Whether sufficient funds can be obtained to continue the trial are also uncertain.

In explaining its decision to appeal the FDA rescission, Amarin simply believes the agency acted “wrongfully,” and failed to mention concerns over outcomes data prior to the advisory committee meeting, even though data was previously available. Nonetheless, Wall Street analysts believe a reversal is unlikely, which may cloud the December 20 approval date for widening the Vascepa indication.

To read the remainder of this article, go to Pharmalot.

Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at Read the RIABiz profile of YCharts. You can also request a demonstration of YCharts Platinum.

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