Believe it: Just as Amarin promised, Vascepa delivers big win in heart-risk study

Call it a promise kept. For years, Amarin has staunchly defended its heart drug Vascepa, despite detractors' disbelief that the drug truly cut cardiovascular risks. According to a new study, it does—and in a big way.

In top-line data unveiled early Monday, the long-awaited Reduce-It study showed that Vascepa cut heart risks by 25% compared with placebo, as measured by a count of major cardiac events commonly used in CV outcomes trials: heart attack, stroke, death from cardiovascular causes, angioplasty or other artery-opening procedure, and hospitalization related to angina. 

That was the trial's primary benchmark, and Amarin said Vascepa also performed on several secondary endpoints, too. Detailed data are up for presentation at the American Heart Association meeting in November, and presuming the company wins a new approval from the FDA to talk up the data, it has a back-pocket plan to staff up on the sales side to get the word out.

It's vindication for Amarin, which staunchly defended the drug—derived from fish oil—even in the face of research showing that fish oil itself didn't cut heart risks. Vascepa is purified and delivers a bigger dose of key omega-3 fatty acids than fish oil supplements do, the company maintained. And now, it can thumb its nose at the critics who've discounted Vascepa and its real-world effectiveness.

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If Amarin's stock performance on Monday is any indication, they're believers now. Shares were up 232% at this writing, to $9.90. That's a whopping boost of $6.95.

The results even outpaced Amarin's expectations, judging by comments from CEO John Thero at the J.P. Morgan Healthcare Conference in January. At the time, Thero was quoting a 15% cut in CV risks and citing Vascepa's affordable price, especially compared with pricey cholesterol drugs in the PCSK9 class.

"Given the safety profile and the pricing of the drug—and its ease of administration—a lower number than 15% would still be received quite positively, but we think there's considerable data to support at least a 15% relative risk reduction," he said.

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Last year, Amarin counted 135 sales reps calling on about 20,000 doctors, CMO Craig Granowitz, M.D., Ph.D., said then. The plan post-Reduce-It—assuming success in the study, which obviously came through—is to hire several hundred more, to hit 400 to 500 reps. That way, Amarin can cover more of the doctors in its target market. Some 600,000 write prescriptions for statins, standard therapy for high cholesterol.

One differentiating factor for Vascepa, now that the numbers are in hand, is proof that the drug can reduce risks in patients with high triglycerides, increasingly recognized as an important indicator of cardiovascular risks, Granowitz pointed out. "Lowering triglycerides lowers outcomes," he said, and "there's not been the right therapy for it."

The revenue boost? At the time, Thero said the amount "should be measured in billions." To get there, Thero's been working to get the right team in place, including Granowitz—who came from Merck & Co.—and a new chief commercial officer from Teva "who's twice taken small groups to well in excess of a billion," he said. "When you marry good technology and good people together, you can accomplish quite a bit."