Amarin's Vascepa goes on TV to lay groundwork for impending CV outcomes data

Amarin's heart drug Vascepa is casting its net with a first-ever TV ad campaign. Although the triglyceride-lowering drug has been on the market for five years, Amarin is anticipating cardiovascular outcomes data this fall—and if the trial comes up positive as hoped, the company wants to be ready to go.

While waiting for the final word, Amarin is running a pilot ad campaign on select TV, print and digital media to hone messaging and begin to raise awareness with physicians as it prepares to roll the drug big.

CEO and President John Thero said Amarin plans to boost sales staff from its current 135 people to between 400 and 500, pending successful trial results for the drug, which is derived from fish oil. The 8,000-patient trial, called Reduce-It, began in 2011 to determine whether taking Vascepa plus a statin reduces the risk of cardiovascular events like heart attack and stroke.

The ads are designed to prime the pump for that expanded sales team. “We’re not running with significant enough frequency to change behavioral patterns, but we do believe we’re running with enough frequency to at least create awareness of what Vascepa is, so that when we do have the results of our study—which is what docs are looking for—it’s not the first time they’ve heard the name,” Thero said in an interview.

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Amarin is also using the advertising to study what physicans and healthcare professionals remember from the messaging—and to a lesser extent what consumers remember—so the marketing team can “refine our message both in terms of what we’re saying as well as where it might be placed,” Thero said.

While Vascepa was approved in 2012 to treat people with very high triglyceride levels, Amarin is looking for an important proof point to show the FDA—and potentially apply to expand its approved indication—that Vascepa has cardiovascular benefits for a broader audience of statin-taking patients.

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In 2016, Amarin won a settlement with the FDA after the agency threatened to crack down on any effort to promote Vascepa beyond its current indication. Amarin sued, saying its First Amendment rights would be trampled if it couldn't discuss trials that showed the drug did lower high blood lipids. The courts sided with Amarin, issuing an injunction against the FDA taking action and leading to the settlement.

The new, 1-minute Vascepa TV ad focuses on the FDA-approved high triglyceride indication, putting Vascepa up against “unproven fish oil supplements.” The total budget for the ad campaign is $15 million to $20 million for this year, which includes creative production, Thero said.

Along with a cardiovascular advantage, Amarin hopes to push an affordability angle with Vascepa. While the list price is about $280 per month—which Thero pointed out was about the same as Lipitor when it first came to market—he said insured users could get the drug for an average copay of about $3 per month. The broader indication riding on the study could open up the volume Amarin will need to make money at those lower price points.