(Adds conference call details, analyst comment; updates share
Jan 21 Amarin Corp Plc's shares fell
more than 26 percent after U.S. health regulators rejected a
preset testing process that was critical to the company seeking
broader use of its blood fat-lowering drug.
The Irish drugmaker said it planned to appeal the decision.
The company may have to drop its bid to treat a wider
population - for which it is currently conducting a large,
multi-year study - if it doesn't succeed, the company said in a
"We see a low probability of successful appeal and ultimate
approval (for expanded use)," FBR Capital Markets & Co analysts
wrote in a note.
Analysts are skeptical of Amarin's ability to run a
profitable business without the new indication of its only
approved drug, Vascepa.
"Even if the larger trial is substantially altered or
discontinued, we doubt the company could achieve break-even
status with just the (current) indication," FBR analysts said.
Amarin recorded third-quarter Vascepa sales of $8.4 million
in the quarter ended Sep. 30, 2013.
Advisers to the U.S. Food and Drug Administration had in
October recommended that the agency not approve Vascepa for the
new use until the larger 8,000-patient trial shows that lowering
blood fats leads to reduced cardiovascular risk.
Vascepa was approved in 2012 to reduce high levels of a type
of blood fat, called triglycerides, in patients not taking
cholesterol-lowering statins such as Pfizer Inc's
Amarin applied last February for approval to sell Vascepa to
patients with blood fat abnormalities who are at high risk of
coronary heart disease and are also taking statins.
LONG ROAD AHEAD
The FDA had in October also revoked a Special Protocol
Assessment (SPA) agreement covering a late-stage trial
code-named ANCHOR, saying that a substantial scientific issue
essential to determining the effectiveness of Vascepa in the
expanded population was identified only after the trial began.
New U.S. guidelines on heart health issued last November,
suggested that individual patient risk of developing heart
disease should be used to determine the need for more intensive
treatment with cholesterol-lowering statin drugs.
The company on Tuesday announced that the regulator had
rejected its appeal to reinstate the SPA agreement.
SPA deals provide companies assurance that the design and
analysis of a trial are adequate to support a marketing
application to the regulator.
"Amarin faces a long road back to redemption," Aegis Capital
analyst Raghuram Selvaraju said in a note.
"The fact that the firm will have to find a way to drive
revenues with only a narrow label in hypertriglyceridemia for
Vascepa negates any likelihood of an acquisition near-term."
Media reports in late 2012 had listed Teva Pharmaceutical
Industries and AstraZeneca Plc as being
potentially interested in buying Amarin.
The Dublin, Ireland-based company's stock has lost more than
84 percent of its value since Vascepa's approval in July 2012.
The drugmaker's American depository shares were down 24.5
percent at $1.72 on the Nasdaq on Tuesday.
(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb