Staff Writer

With Phase III trials for triglyceride-lowering drug AMR101 (ethyl icosapentate) nearly complete, Amarin Corp. plc raised $91.2 million in a public offering of American Depository Shares.

The Dublin, Ireland-based biotech wasn't desperate for cash. Amarin had more than a year's worth of runway, boasting $31.4 million in its coffers as of Sept. 30, 2010, after burning $6.2 million during the third quarter. That money would be sufficient to complete two Phase III trials of AMR101 and submit a new drug application, Amarin said at the time.

The current fundraising, however, allows Amarin to take advantage of its stellar recent stock performance. After hitting a 52-week low of 93 cents last February, the biotech has steadily climbed to its $7.73 closing price on Wednesday, a gain of 731 percent.

A big chunk of those gains came in November, when Amarin reported positive data from its first Phase III trial of AMR101. The drug, a prescription grade omega-3 fatty acid, lowered triglycerides without increasing low-density lipoprotein cholesterol. That claim should help differentiate it from GlaxoSmithKline plc's Lovaza (omega-3-acid ethyl esters), the only prescription-grade omega-3 fatty acid drug currently approved. (See BioWorld Today, Nov. 30, 2010.)

Lovaza, with $750 million in U.S. revenues last year and 83 percent coverage through managed care formularies, has proven consumers will pay for prescription-grade omega-3 drugs rather than just buying fish oil nutritional supplements. The primary reason is that supplements do not undergo rigorous clinical testing and often contain less of the active ingredient than stated on their labels. (See BioWorld Insight, Aug. 23, 2010.)

For now, Lovaza, which GSK gained in its $1.65 billion acquisition of Reliant Pharmaceuticals Inc., stands alone. But competition in the space is poised to increase, as Amarin advances AMR101 and Omthera Pharmaceuticals Inc. starts Phase III trials with its omega-3 drug, Epanova. (See BioWorld Today, Nov. 23, 2010.)

AMR101 is differentiated by its composition of 96 percent ultra pure ethyl ester of eicosapentaenoic acid (EPA), while both GSK and Omthera's drugs contain docosahexanoic acid (DHA). Additionally, while Amarin's first Phase III trial was in hypertriglyceridemia, a second Phase III trial expected to report data in the second quarter of 2011 focuses on mixed dyslipidemia. Some analysts have projected that while the former could be a $500 million to $1 billion market, the latter could be three to 10 times bigger.

Amarin's financing involved the sale of 12 million American Depository Shares priced at $7.60 per share, a discount of only about 1.5 percent to the stock's recent closing price. The shares (NASDAQ:AMRN) gained a further 86 cents, or 11 percent, to close at $8.59 on Thursday.

Underwriters Jefferies & Co. Inc., Leerink Swann LLC and Canaccord Genuity Inc. have a 30-day option to purchase up to 1.8 million additional shares to cover any overallotments.

Net proceeds of $87.1 million are expected to be used to prepare for commercialization of AMR101, as well as for general corporate purposes. Amarin spokespersons were not able to comment due to regulatory restrictions.

AMR101 is the only late-stage candidate in Amarin's pipeline, although the biotech also has some preclinical lipid-lowering programs.