Staff Writer

Amarin's cardiovascular program, AMR 101, seen as the crown jewel of the company's pipeline, has received clearance from the FDA to move forward with a Phase III study in patients with mixed dyslipidemia.

Mixed dyslipidemia is a combination of two or more lipid-related problems: high triglycerides (elevated fatty acids in the blood), low levels of "good" cholesterol and high levels of "bad" cholesterol.

This is the second such study agreement that the Dublin, Ireland-based company has worked out with the FDA for AMR101 in cardiovascular disease, following the May 2009 special protocol assessment for the design of a study in patients with very high triglycerides, or elevated fatty acids in the blood. (See BioWorld Today, June 11, 2009.)

Both cardiovascular trials are expected to begin in the third quarter, depending on the company's long-term funding. Amarin expects the first part of a $55 million financing to pan out later this month, though that plan is all but certain at this point. The company's recent signing of a non - binding term sheet to raise $55 million from existing investors is not a done deal. Although Amarin anticipates that the first closing, the purchase of about $35 million in American depositary shares, could occur on or before July 24, there are no binding terms.

Hapoalim Securities predicted in a research note last month that "there is a strong likelihood of Amarin consummating additional financing within the coming weeks, based on the firm's recent achievements," including securing the first SPA for AMR101 for lowering triglycerides.

Amarin received a $2.6 million bridge financing in May, but those funds are only expected to float the company through this month. Company officials in Ireland were not immediately available for comment.

Wall Street reacted positively last month when the company renegotiated its agreement with privately-held Israeli biotech Ester Neurosciences Ltd., the company that Amarin took over in a $32 million acquisition in 2007. Amarin paid $15 million up front - $5 million in cash and $10 million in stock - and agreed to pay up to $17 million in milestones upon the successful development of EN101. (See BioWorld Today, Dec. 6, 2007.)

But under the new terms, Amarin does not have to pay any of the $17 million, removing a substantial liability from the company's balance sheet.

Analysts have high hopes for the company's cardiovascular compound, an Omega-3 fatty acid known by its generic name, eicosapentaenoic acid (EPA). The active ingredient in AMR101 (ethyl-EPA) is 96 percent ultra pure and prescription grade, while nonprescription Omega-3 supplements have been shown to only have 5 percent to 25 percent of active ingredient.

As a treatment for elevated triglycerides (fatty acids in the blood), AMR101 would be a direct competitor with GlaxoSmithKline plc's Lovaza, which last year recorded sales of $650 million.

Amarin also sought to develop its EPA compound for Huntington's disease, but those studies failed. Still, Amarin submitted an application for the drug (Miraxion) in Europe, and the European Medicines Agency has accepted the application for review as an orpgan drug candidate.

Amarin also has a pipeline drug for muscle weakness, which recently showed encouraging results in a Phase IIa study. That compound, EN101, significantly reduced the disease score in patients with rare genetic disorder myasthenia gravis, data that could make the company attractive to a potential partner. (See BioWorld Today, June 11, 2009.)

However, interim results showed a slightly better improvement in the quantitative myasthenia gravis score of 20 percent to 25 percent, compared to the final results from 31 patients (11.8-20.3 percent).

Shares in Amarin (NASDAQ:AMRN: ticked up 11 cents Thursday, closing at $1.32.