01.01.13
Amarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, has reached a $100 million non-equity financing deal with an investment fund managed by Pharmakon Advisors. In addition, Amarin is continuing its preparations to commercialize Vascepa (icosapent ethyl) capsules, a patented, ultra-pure omega 3 fatty acid product, with the hiring of a sales force in the U.S. Payments by Amarin under this hybrid debt-like instrument are expected to be made over a 3.5-year period commencing in November 2013 and to continue through early 2017.
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, which is an FDA-approved adjunct to diet to reduce triglyceride levels in adult patients with severe (TG >500mg/dL) hypertriglyceridemia. 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.
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 FDA by the end of February 2013 resulting in an anticipated PDUFA action date for the ANCHOR sNDA before the end of 2013.
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, which is an FDA-approved adjunct to diet to reduce triglyceride levels in adult patients with severe (TG >500mg/dL) hypertriglyceridemia. 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.
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 FDA by the end of February 2013 resulting in an anticipated PDUFA action date for the ANCHOR sNDA before the end of 2013.
