Amarin stock rises on news of FDA move

Groton - The biotech firm Amarin Corp. plc, whose stock had been hammered in recent months as questions about patents on its lead medication emerged, revealed Monday that federal regulators won't send the company's pending heart-drug application through an advisory process, a decision that had investors betting on a quick approval.

Amarin, an Irish firm whose research-and-development headquarters are at 475 Bridge St., saw its stock price climb more than 6 percent Monday, to $8.93.

The stock upswing occurred after Amarin put out a pre-market press release announcing that the U.S. Food and Drug Administration does not intend to hold advisory-committee hearings in conjunction with its new drug application for the trygliceride-lowering heart medication AMR101. The FDA traditionally dispenses with advisory-committee procedures only when a drug application lacks controversy and requires little in the way of specialized expertise.

"The lack of a panel in my mind ... does inevitably de-risk the story," said Duane Nash, an analyst for California-based Wedbush Securities who follows Amarin. "It suggests approval sooner rather than later."

Nash said in a phone interview that the lack of an advisory panel also suggests the FDA has not been able to detect flaws in the data Amarin has presented to support the drug application. In addition, a potentially quicker FDA decision could lead companies interested in acquiring Amarin to move from the sidelines to the playing field, he said.

Amarin's stock price, which two years ago had been in the $1 range, climbed to nearly $20 last year on positive data from a key trial of AMR101, a fish oil-derived medicine intended to lower fat in the blood. But the U.S. Patent and Trademark Office's initial rejection of a key patent for AMR101 spooked investors last summer, a trend that brought the price down to the $6 range, and Amarin officials' insistence on going forward with plans to market the medication rather than sell the company to Big Pharma has kept some investors guessing as well, analysts have said.

Amendments to Amarin's initial patent application have been filed, though, and the patent office is expected to issue a ruling next month.

"My gut reaction ... is that they have a 70 percent chance of getting the (amended) patent accepted," Nash said, and, if other amendments are required, an 85 percent chance of approval.

l.howard@theday.com