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Vascepa Vs Placebo: AMRN Stands Behind REDUCE-IT Results

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Amarin Corp. plc (AMRN), on Saturday, presented impressive primary results from its Vascepa cardiovascular outcomes trial, dubbed REDUCE-IT, at the 2018 Scientific Sessions of the American Heart Association in Chicago, Illinois. The study findings were simultaneously published in The New England Journal of Medicine.

Vascepa, approved in July 2012, is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

The REDUCE-IT trial results were initially reported on September 24, 2018, which sent Amarin's stock soaring nearly 315% to $12.40.

In the study, a total of 8,179 patients, who had established cardiovascular disease or diabetes and other risk factors, and receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter), were enrolled.

One half of the patients were given 4 g of Vascepa daily (2g twice daily) and the other half received placebo that contained mineral oil. The patients were followed for on average of 4.9 years.

At the end of the follow-up period, the risk of the primary composite end point of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina was significantly lower, by 25% among those who received 4 g of Vascepa daily than those given placebo.

The risk of the key secondary composite end point of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was also significantly lower, by 26%, in the Vascepa group than in the placebo group.

But some cardiologists are not that excited after going through the data related to the effects of Vascepa on biomarkers from baseline to year 1, says a Forbes article titled "Amarin's Fish-Oil-Derived Drug Shows Great Promise - With Big Caveats".

As per the supplementary details, the median change in the level of LDL cholesterol, or bad cholesterol, from baseline was an increase of 3.1% in the Vascepa group, and 10.2% in the placebo group.

The median change in level of high sensitivity C Reactive Protein, or hsCRP, a biomarker of the underlying inflammation associated with cardiovascular disease risk, from baseline was a decrease of 12.6% in the Vascepa group, but nearly 30% increase in the placebo group.

"Could the placebo be causing some heart problems or strokes, making Vascepa look better than it really is?" notes the Forbes article.

Commenting on the increased level of LDL cholesterol and high sensitivity C Reactive Protein in the placebo group, Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital, tweeted, " This is an important issue - unexpected and puzzling".

But this is what Steven Ketchum, president of research and development and chief scientific officer of Amarin, has to say about the study findings, "The robustness and consistency of these clinical results are exciting. Extensive scientific evaluation led to the design and conduct of this study; but the degree of benefit shown with Vascepa nevertheless exceeded our expectation."

More importantly, Vascepa is affordably priced. According to the Company, the majority of patients covered by insurance who obtain prescriptions for Vascepa pay a monthly co-pay charge of $9.99 or less. A patient with commercial insurance can pay as little as $9.00 for a 90-day supply prescription of Vascepa.

Armed with exciting data, Amarin intends to submit an sNDA to the FDA in early 2019, seeking approval to expand the label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study.

According to biorxivpreprint, "nearly 3 million American adults would potentially be candidates for Vascepa, and if all eligible individuals are treated, the additional cost to the U.S. healthcare system will be almost $9 billion a year".

AMRN closed Friday's trading at $21.05, down 1.17%.

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