Jefferies flasnote:
Amarin Corporation (AMRN) REDUCE-IT Continues as Planned After First Interim
Key Takeaway
The REDUCE-IT trial investigating Vascepa will continue as planned after the first interim analysis by the DMC. We've previously noted that the bar to stop the trial for overwhelming efficacy was high, therefore this comes as expected. The onset of ~80% of events for second interim is expected in H1'17, with analysis in mid-2017. We continue to model success on final analysis expected in early '18, and therefore make no changes to our PT. Maintain Buy.
REDUCE-IT Continues as Planned After First Interim: AMRN announced that the REDUCE-IT cardiovascular (CV) outcomes study investigating Vascepa will continue as planned after the first interim analysis of ~60% of the target aggregate primary CV events by the DMC. We have previously noted that the bar to stop the trial for overwhelming efficacy on the primary endpoint at this interim is high (p<0.0076 to hit significance) with certain secondary endpoints needing to be directionally favorable as well, therefore this outcome comes as expected. We make no changes to our PT and maintain our Buy rating.
Second Interim Analysis Expected in Mid-2017: The onset of ~80% of the target aggregate primary events for the second prespecified interim analysis is expected in H1 2017, with the analysis by the DMC expected in mid-2017. The p-value to stop the trial for overwhelming efficacy at this interim is p<0.0220 for the primary endpoint, with certain secondary endpoints directionally favorable as well. The addition of the second interim therefore gives them a second shot-on-goal, potentially moving up the timeline for Vascepa expansion, if successful. At this time, we continue to model a favorable outcome on final analysis where p<0.0422 is needed for success, expected in early 2018.
