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Amarin Recruits 700 Patients to Test Heart Drug

Amarin Recruits 700 Patients To Test Heart Drug [The Day, New London, Conn.]

From Day, The (New London, CT) (December 17, 2010)

Dec. 17--Mystic-based Amarin Corp. plc has completed recruiting patients for a critical trial of its heart medication AMR101 in people with elevated levels of fat in their blood.

The company said Thursday it has recruited more than 700 people to take part in the so-called Anchor trial. Results should be known by the second quarter of next year.

"We are pleased that the Anchor study has been able to complete the patient randomization process before the end of 2010," said Joseph S. Zakrzewski, executive chairman and chief executive of Amarin, in a statement.

Zakrzewski noted that a previous trial of AMR101, completed last month, showed the drug significantly lowered the triglyceride levels of patients at high risk of heart disease.

Canaccord Genuity analyst Ritu Baral said she expects similar results from the Anchor trial.

"Baral believes the data will be very positive and will show AMR101 has a better drug profile than GlaxoSmithKline’s Lovaza, which has over $1 billion in annual worldwide sales," according to an article in Barron’s.

Amarin’s stock, listed on the Nasdaq exchange under the symbol AMRN, soared after the results of the so-called Marine trial were released in November. Since then, it has continued a slow climb, from $5.85 toward the end of last month to $6.35 at the close of business Thursday.

The stock could be had for less than $1 a year ago.

Amarin said the Anchor trial is being conducted during a 12-week period under a special agreement with the U.S. Food and Drug Administration.

"All patients underwent a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization," the company said in a release.

Amarin said all clinical trials are being conducted in the United States. It believes the 702-patient trial is big enough to show a statistical significance between people treated with AMR101 and those given a placebo.

The trial also seeks to show that AMR101 combined with statin therapy, such as Pfizer Inc.’s Lipitor, does not lead to increased levels of LDL, or "bad" cholesterol.

AMR101, if approved by the FDA, would be the first omega-3 based therapy given marketing approval for those with elevated levels of fat in their blood.

"AMR101 is designed to be first-in-class for this indication," Zakrzewski said. "In the U.S. alone, there are 36 million patients with triglyceride levels in the range being studied."

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Posted: December 2010