Amarin believes that Vascepa is well positioned to compete in the triglyceride lowering market. This is a large market which, based on market research, Amarin believes is currently underpenetrated due to limitations of existing therapies. Amarin's market research further suggests that clinicians value the data supporting Vascepa in the MARINE indication: in patients with very high (≥500 mg/dL) triglyceride levels, Vascepa has been shown to lower triglycerides without increasing bad cholesterol (low-density lipoprotein cholesterol, or LDL-C) and with a tolerability and safety profile similar to placebo. Amarin formally launched Vascepa in the United States on January 28, 2013. In support of that commercial launch, Amarin has:
Vascepa regulatory progress
- More than 160 million lives covered by managed care plans and insurance payors and has begun migrating these plans from Tier-3 to Tier-2 coverage
- Implemented robust early physician awareness and speaker programs
- Implemented a co-pay reduction program that offers Vascepa to patients for a co-pay cost equivalent to competitors
- Realized strong initial wholesale stocking of Vascepa to help ensure that prescriptions can be filled promptly
- Developed and launched a robust digital and print media campaign to support direct sales force efforts to educate various customer segments, including clinicians, about Vascepa
- Received early, but encouraging, feedback from physicians regarding Vascepa and results
On February 26, 2013, Amarin announced that it submitted a sNDA to the FDA requesting approval to market and sell Vascepa to the patient population studied in the ANCHOR Phase 3 trial, adult patients with high triglyceride levels (
200 mg/dL and <500 mg/dL) who are also on statin therapy for elevated LDL-C, which we refer to as mixed dyslipidemia. Assuming that this sNDA is accepted, Amarin expects to be notified within 74-days (inclusive of the standard 60-day review and the standard 14-day communication periods) and anticipates the assignment of a PDUFA action date before the end of 2013 for the ANCHOR indication, consistent with the standard 10-month review period. The safety results from the ANCHOR trial are included in the current label for Vascepa. All of the primary and secondary efficacy endpoints of the ANCHOR trial were achieved at the 4 gram dose.
In the fourth quarter of 2012, Amarin submitted two sNDAs, one each for two additional active pharmaceutical ingredient (API) suppliers for Vascepa, BASF and Chemport. Amarin expects these sNDA filings to be subject to the standard review period for such submissions with potential approvals in the second half of 2013. Qualification of these suppliers is part of Amarin's strategy to expand our supply chain to provide greater capacity to meet anticipated demand, enable supply diversification and flexibility and introduce cost competition among high quality suppliers.