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Amarin Says It's Close To Filing For New Heart Drug

Amarin Says It's Close To Filing For New Heart Drug: Mystic firm nears final stages of testing [The Day, New London, Conn.]

From Day, The (New London, CT) (August 11, 2010)

Aug. 11--MYSTIC -- Biopharmaceutical research firm Amarin Corp. plc said Tuesday that it is moving swiftly toward a possible new-drug filing next year.

Amarin’s interim chief executive officer, Declan Doogan, said in a conference call that the company has completed recruitment for one of its two late-stage drug trials and is more than halfway toward filling out the roster in its other study.

"I’m very encouraged by the progress Amarin has made," Doogan said.

During the conference call, which ran through Amarin’s second-quarter financials, the company’s chief financial officer, John F. Thero, said it spent $5.3 million on preparing for the AMR101 trials during the period. Total expenditures were $6.8 million. The outflows were offset, he added, by about $1.5 million from the exercise of warrants on its stock.

The company’s cash balance of $37.6 million at the end of the quarter will be sufficient to carry Amarin through the completion of clinical trials, he said, and, assuming success, to the filing of a new drug application with the U.S. Food and Drug Administration next year. The FDA would still have to approve AMR101 before it could be marketed to the public.

The company’s 12-week MARINE study, which finished recruitment of 229 patients within the past few weeks, will look at the effect of Amarin’s Omega-3 compound AMR101 on people with very high triglyceride levels, which is a risk factor in heart disease. The company’s 12-week ANCHOR trial will study 650 people with high triglyceride levels who are also on statins such as Pfizer Inc.’s Lipitor.

"Elevated triglyceride levels are increasingly being recognized and treated as an independent, modifiable risk factor for cardiovascular disease," Doogan said in a statement.

Thero said he expects Amarin, at some point in the future, to find a partner to help with the commercialization of AMR101. "We are active in discussion with partners," Thero said.

Doogan added that several global pharmaceutical companies are interested.

Thero said Amarin, which has 16 employees in Mystic’s Packer Building, is working on switching its financial reporting from the company’s original home in Ireland to the United States.

"We are working down that path; it’s a nontraditional path, trying to switch midyear," he said.

Thero added that if regulators can’t make a midyear filing work, Amarin would find other ways to increase financial information available to stockholders. Amarin trades on the Nasdaq stock exchange under the symbol AMRN.

"Our core development team and the majority of our corporate activities are in the United States," he said.

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Posted: August 2010