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Photo Release -- Amarin Reports First Quarter 2013 Financial Results And Provides Update On Operations

Operational update

Commercialization update

Amarin's direct sales force, consisting of approximately 275 sales professionals, made sales calls to clinicians for two months in Q1 2013. Amarin reports that, since launch, access to clinicians has been good, and that it has yet to hear any significant negative reaction to the efficacy or safety profile of Vascepa. Amarin's sales professionals are currently targeting the limited group of clinicians who are the highest prescribers of other lipid therapies. Vascepa is being marketed for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, the initial indication for Vascepa. Amarin believes that Vascepa is well differentiated in this market based on its safety profile, which is similar to placebo, and its spectrum of demonstrated lipid benefit at 4g/day, including statistically significant reductions in triglycerides, Apo B, VLDL-C, and non-HDL-C, with no increase in LDL-C, also known as bad cholesterol.

A chart accompanying this press release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=18620

Since launching Vascepa, Amarin has:

  • Witnessed steady increases in the number of clinicians prescribing Vascepa (now over 4,000), in the number of prescriptions reported (via third-party sources), in the number of bottles of Vascepa shipped from wholesalers to retail pharmacies and in the number of co-pay cards used by patients
  • Witnessed monthly volume (via third-party sources, often underestimated) increase with consistency in the first months post launch with prescriptions increasing from 3,224 to 7,260 to 11,768 normalized TRx, reported in February, March, and April, respectively (normalized TRx equates to 120 capsules, or one month's supply)
  • Focused on clinician education about Vascepa's clinical results and increased product awareness
  • Secured early managed care coverage based on the safety and efficacy profile of Vascepa, including initial Tier 2 conversions (without restrictions) in April and May, noting that it typically takes two-to-three months of time to translate into script data
  • Trained clinicians as speakers on behalf of Vascepa and conducted speaker programs for groups of healthcare professionals
  • Mitigated the Tier 3 vs. Tier 2 co-payment differential for patients with an actively used co-pay discount program (a common program for a new drug until Tier 2 coverage is secured)
  • Received early, but encouraging, feedback from clinicians regarding their patients' initial experiences with Vascepa

Vascepa additional indication progress

In parallel with marketing Vascepa for the MARINE indication, Amarin is pursuing approval of Vascepa for the considerably larger ANCHOR indication. In a clinical trial of the use of Vascepa in the ANCHOR indication, as previously announced, Vascepa demonstrated statistically significant reductions in a broad spectrum of lipid and inflammatory markers, on top of optimized statin therapy, including significant reduction in LDL-C. In April 2013, as previously announced, the FDA accepted for review Amarin's sNDA for the ANCHOR indication that, upon approval, would enable Amarin to market and sell Vascepa for use in the ANCHOR indication. The FDA assigned a PDUFA action date of December 20, 2013 for this sNDA, which date is consistent with the standard FDA ten-month review period. The safety results from the ANCHOR trial are included in the current label for Vascepa. At a daily Vascepa dose of 4 grams, all of the primary and secondary efficacy endpoints of the ANCHOR trial were achieved. As a result, Amarin is optimistic that the FDA will approve Vascepa for this indication.

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