Amarin says it's a 'go' for heart drug

Groton - Amarin Corp. announced Thursday that doctors can start prescribing its new heart drug Vascepa, with a full-scale launch of the capsules expected next week.

Amarin, an Irish company whose research headquarters are on Bridge Street, said Vascepa initially will target patients with very high levels of fat in their blood. The national commercial launch of Vascepa, a highly purified omega-3 fish oil, is set for Monday.

Amarin, whose shares have declined by about one-third over the past few months, decided late last year that it would launch Vascepa on its own rather than partner with a major pharmaceutical company. The decision is a costly one, since Amarin said it will have to hire up to 300 sales representatives for a full-scale launch of Vascepa, the first drug on the market that lowers triglycerides in the blood without increasing the amounts of LDL "bad" cholesterol.

"Ideally, therapy that lowers very high triglycerides should not elevate (bad cholesterol) - a major risk factor for cardiovascular disease," said Eliot A. Brinton, director of atherometabolic research at the Utah Foundation for Biomedical Research and vice president of the American Board of Clinical Lipidology, in a statement released by Amarin.

About 4 million adults in the United States would qualify as potential users of Vascepa based on their high levels of triglycerides, according to the company. The only product on the market for this population, GlaxoSmithKline's Lovaza, had sales of more than $1 billion last year.

"Amarin has worked closely with leading clinical experts and regulatory authorities to bring this important new (product) ... to patients with very high triglycerides," Joseph Zakrzewski, chairman and chief executive officer of Amarin, said in a statement.

The U.S. Food and Drug Administration announced its approval of Vascepa, previously known as AMR101, in the middle of last year.

Amarin is finishing up a study of patients with moderately elevated levels of triglycerides to determine whether they would benefit from Vascepa as well. If the FDA approves Vascepa for this market, Amarin's product could be prescribed to millions of other Americans, increasing its potential sales by nearly tenfold, according to the company.


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