Nota de Canaccord
""We expect AdComm discussion to focus on how recent NON-Omega 3
outcomes studies showing equivocal outcomes benefit relate to
Vascepa’s ANCHOR indication, and if REDUCE-IT outcomes data is
needed pre-approval. The ACCORD, FIELD (Tricor) and AIM-HIGH
(Niaspan) outcomes studies, showed no CV benefit related to TG
lowering in patients with TG’s around the ANCHOR range. We think
FDA will ask the panel if TG lowering in this population may improve
heart health. We note, however, Vascepa is also associated with
modest but stat sig LDL reductions, widely recognized as beneficial.
Even if the panel decides TG is not important, they may find Vascepa’s
total of benefit (e.g. on ApoB, CRP, Lp(a), etc.) meaningful."
"We see 5% chance AdComm will demand REDUCE-IT data preapproval,
95% AdComm is fine with it as a Phase 4 commitment.
REDUCE-IT will not yield data until 2016-2017
"What’s next: what if the AdComm greenlights approval Wednesday? If the AdComm
supports approval before final REDUCE-IT data, we see a relatively clear path to FDA
approval for Vascepa. As we have repeatedly stated, efficacy, as defined by the ANCHOR
SPA, is strong, and the drug has proven to have an incredibly positive safety profile. As
long as the efficacy is deemed meaningful, we see no way approval can be denied. Recall,
the mixed dyslipidemia market is 10x larger than Vascepa’s current indication of TGs of
500+ mg/ml. However, we think there is significant skepticism in the market of AMRN’s
ability to effectively promote to this market segment given the importance of primary care
prescribers and AMRN’s steady but slow launch in the 500+ mg/dL segment. We do
anticipate some overhang and modest strength in the stock if FDA briefing documents due
Monday morning look benign and Wednesday’s proceedings go well."
Nota de JP Morgan
JP Morgan note."Upside/Downside". With an upcoming FDA AdCom meeting on V to treat TG fast approaching....we wanted to share our thoughts on the risk/reward on AMRN shares into the event. Overall, we believe a positive panel is highly likely and view the ANCHOR indication for high TG as the primary value driver of the stock, targeting a potential market 10X the size of V's current label.
While we see fairly equal upside/downside cases for the stock ($2-3),we believe the probability of a positive recommendation (>80%) far ouweighs that of a negative one (<20%). Amarin is operating under a SPA with the FDA and has highly positive data from its ANCHOR and MARINE studies as well as a very clean safety profile with V. While we believe the commercial potential of V will remain a source of controversy in the story, a positive panel woudl help de-risk the pathway to aproval for an indication that accounts for 70%+ of our DCF. Although we see the prob of a neg panel as low we believe the possibility exists for the FDA to ask AMRN to finish its REDUCE IT outcomes studies (expected by 2018) before approving its label expansion. While the 4+ year delay would clearly negatively impact our DCF we believe the label expansion would ultimately be approved and we see clear value in AMRN's Irish corporate structure which we think would help set a floor on the stock ."
AMRN
