Amarin Shuffles Management Again, But Says Omega-3 Trial Results Are Near

On a quarterly earnings call, Amarin's new CEO says two Phase III trials of a drug to lower triglycerides will yield results a few months ahead of schedule.

With a pair of Phase III trials of its Omega-3 fatty acid treatment for elevated triglyceride levels set to deliver results sooner than expected, Amarin Corp. executives say they're already fishing for a Big Pharma partnership, despite losing another chief executive overboard.

In its third-quarter earnings call November 10, Amarin executives adjusted the timeline for two late-stage trials on AMR-101 that address similar but distinct indications. The company expects top-line results from its MARINE study, which tests the drug's safety and efficacy on patients with very high triglyceride levels, by the end of 2010. A second trial known as ANCHOR combines AMR-101 with statins as a therapy for patients with mixed dyslipidemia displaying elevated but less dangerously high triglyceride levels. ANCHOR is now expected to yield top-line data by mid-2011. Each trial's result had been expected several months later.

Amarin chief medical officer Declan Doogan said he viewed the accelerated timeline as a pleasant surprise. While Amarin's cash position will allow it to fund AMR-101 through the filing of an NDA, newly minted CEO Joseph Zakrzewski said the company is seeking a partner for commercialization.

Zakrzewski, one of several executives involved in a management shuffle at Amarin, is the firm's fourth CEO in the past 13 months. The carousel started spinning in October 2009 when longtime executive Thomas Lynch resigned and handed the wheel to Doogan on an interim basis. In August 2010 the company hired Colin Stewart, formerly of CollaGenex Pharmaceuticals Inc., but Stewart has resigned for personal reasons effective November 10, the company said. "Colin is dealing with a personal matter, and we respect his privacy," said Zakrzewski in the call.

Amarin also named Thero president Nov. 10; he had been chief financial officer since November 2009. In addition, vice president of finance Frederick Ahlholm was promoted to chief accounting officer.

An Alternative To Lovaza

Amarin's future hinges almost entirely upon the fate of AMR-101, a prescription-grade formulation of eicosapentaenoic acid (EPA), an Omega-3 fatty acid found naturally in fish oils. The compound is thought to reduce levels of triglycerides in the bloodstream.

Triglycerides, compounds that combine glycerol with fatty acids, are linked to atherosclerosis. Elevated levels can be the result of numerous dietary and health factors, including carbohydrate intake, infrequent exercise and alcohol consumption.

Amarin said 3.8 million Americans have triglyceride levels in the "very high" category, with more than 500 milligrams per deciliter of blood. It is this patient population to which GlaxoSmithKline plc markets Lovaza, which combines EPA with another Omega-3 fatty acid, docosahexaenoic acid (DHA), as a prescription drug. Some patients treat the condition with fish oil products sold over the counter. Lovaza is known as Omacor and marketed by Abbott Laboratories in Europe; the drug produced a combined $1 billion in revenues for the two companies in 2009.

Zakrzewski, who helped develop Lovaza as chief operating officer of Reliant Pharmaceuticals Inc. before the company sold to GSK in 2007 for $1.65 billion, said he believes as many as ten times as many Americans are in an elevated but less severe risk group as in the "very high" triglyceride category. Among mixed dyslipidemia patients who display multiple metabolic symptoms, 200 to 500 milligrams per deciliter of triglycerides, many are prescribed statins such as Pfizer Inc.'s Lipitor (atorvastatin) to treat high LDL cholesterol levels. The ANCHOR study is designed to evaluate whether AMR-101 could reduce triglycerides effectively in those patients without negatively affecting LDL cholesterol levels.

Doogan said both EPA and DHA can lower triglycerides independently, but that their synergistic and antagonistic effects on one another are not well known. Although Amarin executives don't expect AMR-101 to be more efficacious than Lovaza, Zakrzewski said its formulation can be taken in two pills daily rather than four, and that the lack of an approved indication for mixed dyslipidemia patients represents an unmet market opportunity that Amarin can serve.

Enough Cash for Now, But Seeking a Partner

According to its quarterly report, Amarin has $31.4 million on its balance sheet, enough to carry it through an NDA filing for AMR-101. The company reorganized last year, abandoning its central nervous system programs to focus exclusively on cardiovascular disorders.

The company won't have enough cash to commercialize the drug, however, and it will need a partner to step in for that phase. Zakrzewski said discussions have begun already with "greater than five, less than ten" potential partners, giving the company "a multitude of options."

Strapped for cash, Amarin raised $70 million in a private placement last fall, with a series of venture firms providing capital ( (Also see "Amarin Moves Beyond Bridge Financing With $70 Million Private Placement" - Pink Sheet, 13 Oct, 2009.) In its annual report issued in March, the company said Abingworth Management now owns 17.3 percent of its share capital. Sofinnova Ventures owns the second largest stake at 9.5 percent, while OrbiMed Advisors owns 9.3 percent.

At the close of Wednesday's trading, Amarin sported a market capitalization of $323.4 million. Shares were up 27 cents, or 9 percent, to $3.27 apiece.

- Paul Bonanos ( [email protected] )