Amarin rolls out more Vascepa heart benefits data to back label expansion

Amarin has rolled out new Vascepa data that could change the way doctors prevent heart disease. Monday, the company trumpeted more data showing its fish oil-derived Vascepa could significantly cut heart risks, and the drugmaker plans to add the benefits to the product’s label.

Investigators of the REDUCE-IT trial previously found Vascepa could slash the risk of a patient's first major adverse cardiovascular event, such as a heart attack or stroke, by 25%. Now, further analysis from the same trial has shown Vascepa’s effects extend to subsequent events as well.

According to new data presented at the American College of Cardiology annual meeting on Monday, Vascepa reduced the risk of total CV events by 30% compared with placebo in statin-treated patients at a median follow-up of 4.9 years. That could translate into the prevention of 159 more CV events for every 1,000 patients, according to Amarin.

Specifically, in the study on 8,179 patients with well-managed poor cholesterol levels but with elevated triglycerides, the second events were reduced by 32%, or 140 cases, third events by 31% and fourth or more by 48%. Significant reductions were seen across board including in stroke, heart attack, cardiac arrest and heart-related death.

"The degree of benefit that this analysis reveals is quite large, especially considering that this is an additional layer of benefit on top of what statin and other therapies have already provided," the study’s lead investigator, Harvard Medical School's Deepak Bhatt, M.D., said in a statement.

Vascepa is currently approved by the FDA as an adjunct to diet to reduce triglyceride levels. Now, the cardiovascular outcomes data offers Amarin a potential opportunity to tout Vascepa’s application outside of cholesterol management. In a Monday statement, Amarin president and CEO John Thero said Vascepa "opens the door to a new era in preventative cardiovascular care." As Amarin noted, about half of patients who suffered a heart attack are likely to experience another CV event within a year, and up to 75% of patients have a recurrence within three years, stressing the importance of consistent benefits.

The company seeks to submit an application by the end of March to include the CV benefit on Vascepa’s label. But even assuming the label expansion doesn't come in 2019 under the standard FDA evaluation timeline, the company is guiding to 2019 revenue of $350 million. That's compared with 2018’s $229 million, with the increase driven predominantly by Vascepa, the company’s only commercial product.

During the company’s fourth-quarter earnings call in late February, Thero said the FDA might initiate an advisory committee meeting on the approval, given that it’s a "precedent-setting filing." He argued that the meeting was not necessarily a bad thing, as the FDA might want to use it as an opportunity to emphasize the difference between prescription therapy and dietary supplements.

The drug, a purified form of the omega-3 acid known as EPA that’s found in fish oil, and the REDUCE-IT trial, have had their share of controversies. When Amarin unveiled the first-occurrence data last November, critics blamed the placebo—a mineral oil-filled pill that physically looks like Amarin’s—for negatively affecting results in the control arm and in turn inflating Vascepa’s effectiveness profile. The dummy pill appeared to have elevated the levels of LDL in patients, which is usually linked to higher heart risks. At that time, Amarin pointed to a post-hoc analysis which showed benefits regardless of whether of patients' levels of LDL.

Despite the controversies, physicians seemed to welcome Vascepa’s original data. In a note to clients on Jan. 30, Cantor Fitzgerald analysts said the 50 physicians they interviewed collectively would double their prescriptions of Vascepa year-over-year, with data from the REDUCE-IT trial cited as the key driver. About half of physicians recognized that high triglyceride patients have CV risk factors that can’t be mitigated by cholesterol management.

Prescriptions have indeed ticked upward since, helped by Amarin's increase of U.S. sales reps from about 150 to 400 after REDUCE-IT. In another note last Friday, the Cantor team noted a year-over-year total prescription and new prescription increase of 53.8% and 66.1%, respectively. According to Thero on the fourth-quarter call, Amarin intends to start direct-to-consumer promotion of Vascepa once it nabs label update.

Meanwhile, Amarin’s positive Vascepa data have reportedly made the company an M&A target of Pfizer, the seller of one-time CV king Lipitor. Thero also wouldn’t comment on the rumor on the fourth-quarter call, but added that "Amarin is confident in our ability to significantly grow our business."

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