The Irish drugmaker said it planned to appeal the
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 conference call.
"We see a low probability of successful appeal and ultimate approval
(for expanded use)," FBR Capital Markets & Co analysts wrote in a
Analysts are skeptical of Amarin's ability to run a profitable
business without the new indication of its only approved drug,
"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 Lipitor.
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.
[to top of second column]
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
"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 Chakrabarty)
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