After Vascepa's approval announcement, much is being made of whether or not Vascepa gets FDA's blessing as a new chemical entity or NCE. Investors will find out Vascepa's NCE fate as early as Friday, August 17, when the FDA publishes its next update to the Orange Book. We argue herein that NCE status, while it will affect short-term stock price, is unlikely to have a practical effect in buyout valuations and in drug marketing.
What's at Stake
The stakes for AMRN are the difference between new drug product exclusivity, which fends off generic competitors for three years versus NCE which fends off competition for five years. Many investors believe that the larger stakes are whether or not NCE status affects the valuation of the company in a potential buyout scenario since this is AMRN's preferred course of commercialization. Indeed, AMRN has been described as having three separate binary events in the form of FDA approval, NCE status, and issuance of the '889 patent for their drug.