Biotech Values

[DewDiligence]

Re: AMRN’s prospects

I'd be interested in your views on AMRN…

I think the sNDA based on REDUCE-IT is very likely to be approved, although the FDA will probably want to convene an advisory committee. The impetus for an adcomm is not the “placebo” issue per se, but rather the large addressable market for the expanded indication. I expect the panel to be longwinded on showmanship but ultimately supportive of the sNDA, given the strength of the REDIUCE-IT dataset.

Where I’m somewhat more skeptical is on Vascepa’s commercial uptake in the expanded indication, specifically vis-à-vis patient compliance.

We know that patient compliance with statin therapy is spotty, and statin doses are a single small daily tablet. Vascepa, dosed as four horse-sized capsules per day, may be a tough regimen for patients to follow in a (mostly) symptomless medical condition.

I suspect that patient compliance will be better when Vascepa is prescribed by a cardiologist rather than a GP; however, I question how many of even the sickest Vascepa patients will follow through with their doses day after day, indefinitely.

Of course, the sales-uptake issue won’t be relevant to AMRN longs if the company is acquired before the sNDA is approved; however, potential AMRN suitors are likely thinking along the same lines as I am about compliance, so a blockbuster buyout in the near future might not be in the offing.

Disclosure: No position.