|
 Shares of the company jumped 18% to $19.97 ahead of the drug's
evaluation on Thursday by an expert panel of advisers to the U.S.
Food and Drug Administration.
A late-stage trial last year showed Vascepa cut the combined rate of
heart attacks, strokes and other cardiovascular events by 25%.
But some experts argued the use of mineral oil as placebo in
Amarin's trial worsened bad cholesterol levels in patients or
affected the absorption of the statin cholesterol drugs they were
on, which could have skewed results in favor of Vascepa.
Vascepa, Amarin's only drug, originally won U.S. approval in 2012 to
lower high levels of triglycerides — a type of blood fat that can
increase the risk of heart disease.
Amarin is now seeking to include on the treatment's label its
benefits of reducing the chance of heart attacks and strokes in
patients with cardiovascular disease.
FDA staffers on Tuesday said their tests were inconclusive on
whether the use of mineral oil as placebo could have impacted
results.
While they could not rule out the possibility that mineral oil
interfered with statin absorption, they said any interaction between
the placebo and statin was expected to be minimal.
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"We do believe everything should be subject to scientific scrutiny,
but I think this (the concern) is something that Wall Street has
created rather than science - I suspect the comments of the FDA will
largely dispel that," Chief Executive Officer John Thero told
Reuters.
The big question around approvability due to use of mineral oil
looks to be unlikely to cause any issues for label expansion, said
Jefferies analyst Michael Yee.
An expanded label for the drug could open up a market of nearly 15
million Americans who have high triglycerides and other
cardiovascular risk factors, despite being on statin treatment to
lower cholesterol.
Roth Capital Partners analyst Yasmeen Rahimi expects Vascepa to
capture about 12.1% of the market over the next decade, resulting in
peak U.S. sales of $3.2 billion by 2030.
"The Street was a little nervous about what could be thrown their
way. Now the surprise is gone," said Rahimi.
Amarin recorded revenue of $229.2 million last year.
(Reporting by Saumya Sibi Joseph and Trisha Roy in Bengaluru;
Editing by Maju Samuel and Shinjini Ganguli)
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