Upgrade to SI Premium - Free Trial

Amarin Corporation (AMRN) PT Raised to $51 at H.C. Wainwright; REDUCE-IT Update is a 'Home run'

November 12, 2018 7:44 AM

H.C. Wainwright analyst Andrew Fein raised the price target on Amarin Corporation (NASDAQ: AMRN) to $51.00 (from $31.00) while maintaining a Buy rating.

Fein commented, "The detailed data presentation of the REDUCE-IT trial of Vascepa at this year’s American Heart Association (AHA) conference in conjunction with the publication in the New English Journal of Medicine (NEJM) provided much anticipated color on Vascepa’s clinical benefits and commercial potential, which in our view, landed in the best scenario and surpassed our expectation. We believe that beyond the topline of 25% reduction of MACE score, the robustness of the data is highlighted by the consistency across pre-specified analyses. A key secondary composite, namely 3-point MACE score (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke), which assesses the major CV events (and reflects the most important clinical relevance), showed an even higher reduction of risks at 26% compared to placebo. The clinical benefits as measured by the primary endpoint of MACE score and the key secondary 3-point MACE score are observed across subgroups (statistically significant in the vast majority of the subgroups), which speaks to the validity and robustness of the data. We echo the sentiment expressed by some KOLs present at the meeting that the REDUCE-IT trial data may be viewed as “unprecedented” and “paradigm-changing” in the context of minimal or modest benefits historically achieved by various therapies on top of statins. We point out that the subgroup analysis may give the first peek into the commercial potential of Vascepta: regardless of baseline triglycerides levels (≥150 vs. <150 mg/dL), diabetes status, baseline LDL-C, Vascepta provides similarly robust CV benefit. This, compared to the current label of Vascepa which is only indicated in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL), should significantly broaden Vascepa’s target patient population if the FDA grants the label expansion. With regard to the placebo (mineral oil) controversy, we view it as temporary noise that has been given an oversized weight by the bears. We are not aware of any strong evidence supporting that mineral oil contributed to the worsened outcome on the placebo arm. At most, we believe it mounts to speculation and hypothesis of the potential physiological activity of mineral oil without any clinical validation of such claims. In any case, the possibly minimal biological activity of the placebo arm would not negate the robustness of the results, in our view. We expect the placebo issue to be raised during the FDA review, but do not believe it would negatively impact the regulatory outcome. As far as the safety signals go, the increased risk of atrial fibrillation should be offset by the reduction in stroke, according to our KOL, since atrial fibrillation often leads to stroke which was actually decreased with Vascepa’s treatment. We think perhaps a more relevant question for Vascepa now is how the data is received by physicians and how the REDUCE-IT results would change the uptake of the drug and physicians’ prescription regimen. If there is any indication, we point to the survey conducted at AHA after the presentation where it asked physicians how they plan to change practice after the REDUCE-IT data, and 87% of the audience said they would prescribe Vascepa to all high risk patients with moderate TG levels."

Categories

Analyst Comments Analyst PT Change Hot Comments

Next Articles