Amarin is most likely delaying the action in hopes of hearing from the FDA regarding Vascepa’s New Chemical Exclusivity status, which may be posted in the November edition of the FDA’s Orange Book, due in mid-December. That decision will be highly determinant for potential buyers or partners for Amarin, as NCE status grants five years of market exclusivity, intellectual property aside, making the product a far more secure asset. Amarin is signaling that they still hope to either partner or sell the company rather than take Vascepa to the market alone, an expensive and labor-intensive undertaking. The backing of an established pharmaceutical player is a much more stable route for marketing Vascepa.
Today’s announcement should be good news to investors, despite a prolonged waiting period, as the company appears reticent to commercialize Vascepa alone and will ideally continue pursuing a partnership. The company maintains that Vascepa will launch in the first quarter of 2013 one way or another, but a buyout would be the best possible scenario for AMRN investors.