Roth’s take:
AMRN: Makes Hay While the AdCom Sun
Shines
Yesterday, AMRN disclosed FDA's notice of plans to hold an AdCom (~Nov. 14) in connection with Vascepa sNDA. While this news took the Street by surprise, AMRN has been in full prep mode for AdCom since Day 1 and, therefore, will walk into the meeting fully primed to bring home an expanded label. In this report, we outline why the AdCom helps rather than harms Vascepa and how the new AdCom members are far more receptive than the 2013 crew.
While a lower likelihood had been given in recent guidance, Vascepa AdCom for label expansion can be a good thing for AMRN. With 52 days left on the clock for the priority-review PDUFA, AMRN received word yesterday regarding plans for a Nov. 14 Endo and Metabolic AdCom. While the timing of AdCom announcement is surprising given how close we were to the Sept. 28 PDUFA, mgmt reiterated on an update call that before Priority Review for sNDA was given by the FDA in May, AMRN had operated under the assumption that an AdCom was likely. AMRN believed this would be the case due to the importance of the indication it was seeking for Vascepa label extension. Thus, AMRN will have a deep well of preparation to pull from for presentation at the Nov. AdCom. We believe that beyond simply defending label expansion for Vascepa, AdCom provides AMRN with the opportunity to showcase the entire Vascepa treasure chest: 1) REDUCE-IT sets the highest bar in CVOTs, with 25% risk reduction on 5-pt MACE and a 20% reduction in CV-death; 2) 30% risk reduction in total CV events; 3) Good alignment in efficacy between MARINE, ANCHOR, and REDUCE-IT; 4) Vascepa has a uniformly clean safety profile, which makes it suitable for a large indication like hypertriglyceridemia; 5) Deep scientific rationale that supports multiple MOAs at work, including anti-inflammatory, anti-oxidant, and anti-thrombotic effects; 6) Strong support from the medical community, including recognition by ADA that diabetics with ASCVD, well-controlled LDL-C, and elevated TGs be prescribed Vascepa
based on REDUCE-IT; and 7) AdCom allows for Vascepa discussion in a public forum, increasing awareness and transparency on key issues, and puts all this info just a click away for potential future Vascepa-prescribers to find and digest. In totality, we believe AMRN is primed to make a strong case to the FDA and can turn this AdCom into a highlight reel of the CV benefits Vascepa offers patients.
Chair of the AdCom is an Endo, meaning Vascepa will have a receptive audience, in our view. We point out that the current Endo and Metabolics AdCom roster (n=13) is entirely different from that which advised on the 2013 AdCom. We see this as a positive, with members approaching the dataset with a fresh view. As 5/13 AdCom members are endos, we believe receptiveness to Vascepa is already built in given the ADA's embrace of AMRN's drug. Cardios and nephros are the remaining members, with the final spot a consumer rep.
AI
