The Burrill Report

Amarin has gained U.S. Food and Drug Administration approval for its fish oil-based high cholesterol drug, Vascepa, as the company awaits an agency decision as to whether to grant the drug five-year new chemical entity or three-year new product marketing exclusivity.

The company expects the agency will make that decision, which will impact the drug’s ultimate profitability, by the middle of August. It anticipates commercial launch of Vascepa early in the first quarter of 2013.

In a strategic update announced with the approval, Amarin also says it is considering three potential paths for bringing the high triglyceride fighter to market: selling the company, forming a strategic collaboration, or self-commercialization.

Canaccord Genuity life sciences analyst Ritu Baral says she expects business development talks at the company to intensify and Vascepa to receive the five-year exclusivity protection a new chemical entity designation would grant. By 2017, she projects peak sales of the drug could reach $700 million annually.

In addition to gaining approval for Vascepa, Amarin says it has made significant progress in its efforts to expand U.S. patent protection on the drug to at least 2030 with seven patent applications either issued, allowed, or in litigation and more than 25 additional U.S. applications pending. A day before the approval, the company announced that the European Patent Office also intends to grant the company a European patent to protect Vascepa.

As many as 70 million adults in the United States and 210 million adults worldwide have elevated triglyceride levels, according to Datamonitor. For those seeking treatment for the condition, says Joseph Zakrzewski, Amarin’s chairman and CEO, "Vascepa represents the introduction of an important new treatment.”







July 27, 2012
http://www.burrillreport.com/article-amarin_wins_fda_approval_of_vascepa.html