Amarin Corp Plc (AMRN)

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Jefferies Update;

Amarin Corporation (AMRN) FDA Grants NCE Exclusivity for Vascepa Key Takeaway AMRN announced that the FDA has granted Vascepa 5-year new chemical exclusivity (NCE), which runs from its date of FDA approval on Jul 26, ’12 and extends until Jul 26, ‘17. Any potential P-IV filing for Vascepa therefore would come no sooner than Jun 26, ’16. We view the news as a positive for AMRN but make no changes to our model as we already assume patent protection for Vascepa out to ‘30. FDA Grants NCE Exclusivity for Vascepa: AMRN announced this afternoon that the FDA has granted Vascepa 5-year new chemical entity (NCE) marketing exclusivity, which runs from its date of FDA approval on Jul 26, 2012, and extends until Jul 26, 2017. Any potential Paragraph IV filings for generic Vascepa, therefore, would come no sooner than Jul 26, 2016. The 30 month statutory stay is extended to Jan 26, 2020, or 7.5 years from FDA approval.

A Positive for AMRN But No Changes to Our Model; We Assume Patent Protection for Vascepa Out to 2030: We view the news as positive for AMRN but we make no changes to our model as we already assume patent protection for Vascepa out to 2030, where we see $1.0B in peak sales in the severe hypertriglyceridemia (unadjusted) and mixed dyslipidemia (75% risk-adjustment) populations. AMRN has prosecuted several patent applications on Vascepa for cardiovascular indications; to date, AMRN has had 46 U.S. patent applications that have been issued or allowed, the majority of which expire in 2030. AMRN also has several additional patent applications that are still pending