Amarin: NCE status still uncertain; launch trends are what matter now- MKM Partners (8.28 -0.19)
MKM Partners notes that the FDA once again failed to rule on regulatory exclusivity for Amarin's Vascepa. This is the sixth delay to the NCE decision, and they continue to assume that Amarin will be unable to successfully petition the FDA to grant Vascepa NCE status. With the next Orange Book update not expected until around February 15 and the Vascepa launch expected in the next two weeks, they think both investors and potential acquirers will focus on early Vascepa prescription and sales trends, making a fast launch extremely important. They also think it is unlikely that Amarin will be acquired before the ANCHOR indication expected approval in late 2013.