Amarin's Vascepa Cuts Heart Risk in Outcomes Test, Stock Down

Shares of Amarin Corporation plc AMRN were down almost 6% after it presented detailed data from a late-stage cardiovascular outcomes study (REDUCE-IT) on its fish oil capsule, Vascepa, at the Scientific Sessions of the American Heart Association (AHA) in Chicago, Illinois.

However, the stock has skyrocketed 394.3% so far this year versus the industry’s decrease of 16.6%.

Notably, Vascepa is already approved in the United States as an adjunct to diet in order to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. The REDUCE-IT study evaluated whether patients with bad cholesterol, controlled by statin therapy, and at cardiovascular risk can achieve a significant cardiovascular risk reduction after being treated with Vascepa.

In September 2018, the company presented top-line data from the study, which demonstrated that Vascepa can significantly lower cardiovascular risk in patients with LDL-C (bad cholesterol) controlled by statin therapy. Back then, the REDUCE-IT analysis showed that the use of Vascepa 4gms/day resulted in 25% relative risk reduction (RRR) as the primary endpoint of a major adverse cardiovascular event (MACE) when compared with placebo.

MACE is a composite endpoint of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or unstable angina requiring hospitalization. Along with its latest release, the company confirmed the 25% RRR in the five-component primary MACE endpoint.

The company also stated that treatment with Vascepa led to a 26% reduction in key secondary composite endpoint of cardiovascular death, heart attacks and stroke. The study also achieved the additional secondary endpoints including reductions in cardiovascular death (20%), fatal or nonfatal heart attacks (31%), fatal or nonfatal stroke (28%), urgent or emergent coronary revascularization (35%) and hospitalization for unstable angina (32%). However, the study failed to achieve a statistical significance for the all-cause mortality secondary endpoint.

However, despite the positive data, shares of the company declined on Monday because of investor concerns regarding the use of mineral oil in the placebo arm, which might have caused an unexpected rise in bad cholesterol levels. This in turn, overstated Vascepa's cardiovascular benefits.

Amarin plans to file a supplemental new drug application (sNDA) to the FDA in early 2019 for expanding the label of Vascepa based on results acquired from the REDUCE-IT study. The company anticipates a potential approval in late next year following the regulatory body’s review.

If Amarin gets the nod to include the outcomes data on Vascepa’s label, it can cater to a larger patient population and generate higher sales. The company has moderately priced the drug to make it affordable for its patients.

Zacks Rank & Stocks to Consider

Amarin currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Gilead Sciences, Inc. GILD, Alexion Pharmaceuticals, Inc. ALXN and Genomic Health, Inc. GHDX, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead Sciences’ earnings estimates have been revised 4.4% upward for 2018 and 4.2% for 2019 over the past 60 days.

Alexion’s earnings estimates have moved 4.8% north for 2018 and 1.8% for 2019 over the past 60 days.

Genomic Health’s earnings estimates have been raised 89.3% for 2018 and 36.7% for 2019 over the past 60 days. The stock has skyrocketed 132.8% year to date.

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