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Mystic firm readies heart drug's FDA filing

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Mystic-based biotech firm Amarin Corp. plc said Monday that it has completed all studies for its heart drug AMR101 and expects to file by the end of September for formal regulatory approval to market the potential blockbuster.

Amarin, which has offices in the Mystic Packer Building, previously has said it hopes the U.S. Food and Drug Administration, the agency responsible for regulating the pharmaceutical industry, will approve the new medicine next year.

"The Amarin team is now focused on completing the final work for the AMR101 (new drug application) package, and we are looking forward to moving into the regulatory review process," said Joseph Zakrzewski, Amarin's chairman and chief executive, in a prepared statement.

AMR-101, a highly purified Omega-3 fish oil, has been shown in clinical studies to reduce the amount of fat in patients' blood, a risk factor in coronary heart disease. Amarin's initial filing will be for patients with very high levels of triglycerides, but the company is also preparing to request that the FDA approve AMR-101 for use in patients with levels of fat in the blood at a slightly lower threshold.

Amarin said its pharmacology studies showed that AMR101, which will soon be given a more commercial name, was a safe drug, well tolerated by patients.

"The overall safety profile of AMR101 is comparable to placebo," the company said.

AMR101 has been compared favorably with GlaxoSmithKline's heart drug Lovaza, which had more than $1 billion in sales last year.

Lovaza lowers triglycerides but also increases LDL "bad" cholesterol, and is not indicated for people at lower risk of heart disease, according to regulators. But Amarin hopes to tap into a market of 40 million people who also have elevated fat in their blood but at a lower threshold than for those taking Lovaza.


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