ESC: Amarin touts Vascepa's ability to reduce repeat heart problems as it fights generic with 'skinny label' claim

Amarin Vascepa box
Amarin's fish oil-derived Vascepa showed it could prevent further cardiovascular events both at first occurrence and total count throughout a phase 3 trial in patients who had had prior heart attacks. (Amarin Corporation)

Amarin has shored up additional data to back its Vascepa pill to protect against heart problems in patients who’ve already had a heart attack. But piling up more prevention evidence might not help much if the company can’t fight off a cheap generic that’s targeting a smaller indication.

Vascepa cut the risk of major cardiovascular events for those patients—such as a repeat heart attack or stroke—throughout the phase 3 Reduce-It trial, Amarin said at the European Society of Cardiology annual congress.

Vascepa reduced a first heart-related event by 26% and total events by 35%, the analysis found. The composite marker, known as MACE, covers heart-related death, heart attack, stroke, coronary revascularization and hospitalization for lack of blood flow to the heart.

Earlier results from Reduce-It won Vascepa an FDA nod for use on top of statins to prevent cardiovascular events in high-risk patients. The new data are from a subgroup of patients with established cardiovascular disease in the so-called secondary prevention setting.

Vascepa was originally approved to lower bad cholesterol, but it’s the cardiovascular benefit label that’s more important and is getting the bulk of sales, which tallied $295 million in the first half of the year.

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Reducing cardiovascular disease was billed as a blockbuster opportunity for Vascepa, Amarin’s only product. But those ambitions took a hit late last year when Hikma launched a generic version. Although the copycat is only available for lowering cholesterol, the potential that it could be prescribed for the all-important heart outcomes use is scary for Amarin.

Amarin has been fiercely fighting Hikma in court. But in June, the U.S. Supreme Court declined to take on the company’s case to revive six patents on Vascepa that were invalidated by a lower court. The decision effectively allowed Hikma’s generic—and potential future copycats—to remain on the market for cholesterol treatment.

But Amarin has developed a new strategy, suing Hikma for promoting its version for reducing the risk of cardiovascular disease, which would infringe on Vascepa’s patents. After Vascepa’s CV nod, Hikma removed a sentence on its generic’s label that stated the drug’s CV benefits hadn’t been established.

Health Net, an insurance provider, was also dragged into the case. The insurance company’s plans placed generic Vascepa in a group that had a lower copay than branded Vascepa, and some of its plans required prior authorization before covering Vascepa or the generic.

Problem is, a doctor, in filing for coverage, must specify whether the drug is used for either the cholesterol or the CV indication. Amarin is alleging that with those policies, Health Net is promoting prescription of the generic among doctors, including for the CV use.

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GlaxoSmithKline’s recent win against generic maker Teva over heart failure med Coreg in a similar “skinny label” case may bode well for Amarin. But the insurer component in Amarin’s Vascepa suit appears to be novel.

In the meantime, Hikma appears to have been struggling with its generic supply, giving Amarin more room to make inroads with its branded Vascepa. But it remains to be seen whether Vascepa will suffer more once generic production stabilizes.

Outside the U.S., Amarin believes Europe presents a sales opportunity that's equal to or even larger than the U.S. In Europe, where the drug is sold under the brand Vazkepa, Amarin plans to launch first in Germany in September 2021 with the help of a field force of about 150 sales reps, Amarin’s newly installed CEO, Karim Mikhail, told investors during a call early August.