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Amarin nearing decision on self-commercialization of new drug

By Lee Howard

Publication: theday.com

Published November 08. 2012 5:00PM   Updated November 08. 2012 11:59PM

Groton — Amarin Corp., still working on a collaboration to market its newly approved heart medication Vascepa but finding it difficult because of uncertainty over the length of time the company will have patent exclusivity, plans to make a decision by the end of this month whether to start hiring its own sales force.

Joseph Zakrzewski, Amarin president and chief executive, said Thursday in a quarterly conference call that the company currently has inquiries from nearly 2,000 experienced sales representatives, many of whom already have connections with the doctors who would be most interested in Vascepa, a fish oil-based drug that lowers fat in the blood. He added that the company, which needs between 250 and 300 sales reps nationwide, will make a final decision on whether to begin gearing up for self-commercialization by mid- to late November.

“We really have our pick of the litter,” Zakrzewski said.

Zakrzewski said discussions with other companies about a possible acquisition or strategic collaboration with Amarin to market Vascepa have bogged down as the U.S. Food and Drug Administration has dragged its feet on whether to name the triglyceride-lowering drug a new chemical entity. The designation would give Amarin five years of marketing exclusivity, while the company would win only a three-year period without facing generic competition without the so-called NCE status.

“It’s an overhang,” Zakrzewski said. “We continue to request that the FDA make a timely determination.”

Zakrzewski said Amarin still plans to launch Vascepa in the early part of next year. He added that the company currently has eight patents either issued or allowed in the United States and another 30 pending.

The company, which has offices on Bridge Street, currently has nearly 100 employees nationwide as it gears up for commercialization. In January of last year, employees totaled only 17, most of them locally based.

“When you look at the data we have ... this is a very, very special product,” he added.

l.howard@theday.com

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