In a conference call last week, Amarin Corp. plc CEO Joe Zakrzewski insisted that it would be "a mistake" to assume that the company's decision to launch Vascepa (icosapent ethyl) on its own through the use of a $100 million debt instrument meant that it had abandoned its search for a partner for the fish oil-based product it is developing for the cardiovascular disease market.

Rather, Zakrzewski said, "At some point, you've got to get on with it," referring to launch plans for the drug, which was approved in July.

The $100 million nonequity financing through an investment fund managed by Pharmakon Advisors will allow Amarin to hire a sales force of 250 to 300 representatives for the product's launch in patients with very high fasting triglyceride levels.

Amarin is determined to carry through with its plans for commercializing Vascepa, in spite of not landing a big pharma partner for the drug.

Amarin's stock (NASDAQ:AMRN) fell $2.26, or 19 percent, to close at $9.69 Friday, as investors processed the news.

Its preparations for Vascepa's launch include working with managed care plans to gain formulary access, building up inventory, hiring and developing marketing materials, biding its time following approval, "unlike some small companies who have rushed to launch products immediately after approval," Zakrzewski said.

Amarin's ultimate plans for commercializing Vascepa include acquisition, strategic collaboration or self-commercialization with third-party support.

Amarin presented the move in a positive light, emphasizing that the debt financing will not dilute the company's equity. According to Zakrzewski, debt payments can be made over a 3.5 year period, and the total cost is "approximately half" of what it would cost to execute an equity transaction.

Meanwhile, Amarin will be continuing discussions with big pharmas.

Vascepa's approval was based on data from the company's MARINE clinical trial showing that adult patients with very high fasting triglyceride levels (between 500 mg/dL and 2,000 mg/dL) treated for 12 weeks with 4 g per day of Vascepa had a statistically significant placebo-adjusted median triglyceride reduction of 33 percent (p < 0.001), and did not show an increase in LDL-C levels relative to placebo. (See BioWorld Today, Nov. 17, 2011, and July 27, 2012.)

At the same time, there was not an increase in levels of LDL-C relative to placebo, and the drug dosed at 4 g per day also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C (total cholesterol less "good cholesterol") of 18 percent.

Vascepa will go head to head with GlaxoSmithKline plc's Lovaza (omega-3-acid ethyl esters), which according to GSK's 2011 annual report, turned in sales of £569 million (US$892 million).

Amarin is still waiting to hear from the FDA as to whether Vascepa will be granted five-year new chemical entity (NCE) or three-year new product marketing exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.

New chemical entity status would be based on the fact that Vascepa is purer and better characterized than Lovaza. There is some precedent for NCE status for purified products. Sanofi SA's Lovenox (enoxaparin), a low-molecular weight heparin purified from longer polymeric heparin chains, was given NCE status.

Typically, that decision would be posted on the agency's website in the Orange Book, a determination that is expected within the week.

In response to questions about the timing of the financing deal just before the anticipated Orange Book publication, Zakrzewski denied that the company has any knowledge of what that outcome will be, calling the coincidental timing "an anomaly," and the whole issue "an overhang and much ado about nothing."

"We think we're going to be in great shape regardless," Zakrzewski said.

"We believe all strategic options are still on the table for the company, and this move maintains deal tension by demonstrating that management is ready," wrote Leerink Swann analyst Joseph P. Schwartz.

Schwartz opined that lack of clarity on the new chemical entity decision has led to difficulty pricing the company's assets precisely, and that two pending Vascepa "use" patents based on Amarin's MARINE and ANCHOR studies could help to remove the NCE overhang.

Those patents could extend Vascepa exclusivity through 2030.

"We believe this justifies significant long-term upside to the current stock valuation and increases the likelihood of an eventual pharma deal," wrote Jefferies and Co. analyst Thomas Wei.