The initial commercial launch of Vascepa is planned for early in the first quarter of 2013. The company is hiring 250-300 specialty sales professionals for the launch of Vascepa for its initial indication, the MARINE indication, which is approved by the U.S. Food and Drug Administration (FDA). Amarin's goal is for every sales representative hired to have, at a minimum, three to five year existing relationships with the identical physician groups Amarin will be calling on and educating about Vascepa.
In addition to hiring a sales force, Amarin has been focused on continued commercial preparations for Vascepa which, as previously disclosed, has included, but has not been limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building up inventory levels, hiring key personnel (e.g., managed care, marketing, sales infrastructure, pricing), developing direct-to-consumer advertising and speaker training and coordinating other pre-launch marketing activities.
Amarin's hiring of a sales force is part of a continuing strategy to evaluate three potential paths to Vascepa commercialization: an acquisition of Amarin, a strategic collaboration, and self-commercialization, the latter of which could include third-party support.
"This transaction provides Amarin with non-dilutive capital that will ensure our ability to fully execute on the Vascepa product launch while continuing our strategic partnership discussions," stated Joseph Zakrzewski, Chairman and CEO of Amarin. "This innovative transaction allows maximum flexibility for Amarin."
Vascepa's next indication, for the patient population studied in the ANCHOR Phase 3 trial, remains on target for a Supplemental New Drug Application (sNDA) submission to the FDA by the end of February 2013 resulting in an anticipated PDUFA action date for the ANCHOR sNDA before the end of 2013.