Amarin Wins FDA Panel Nod to Expand Heart Drug Vascepa’s Label

(Bloomberg) -- Amarin Corp. shares may extend their recent gains after an advisory panel to the U.S. Food and Drug Administration voted unanimously in favor of expanding the label for its heart drug Vascepa.

All 16 panelists voted that the drug should be sold as a medicine to reduce the risk of cardiovascular events like stroke and heart attack, agreeing that the drug was both safe and effective. The approval could open up the potential patient population to 10 million from 600,000 currently, SVB Leerink estimated in a note earlier this month.

A key debate for panelists was to what extent the label should broadened, and whether patients who have not had a stroke, or have cardiovascular disease, benefit. The conversation also centered on how high patients’ triglycerides, a type of fat in the blood, must be to benefit.

“There are some uncertainties here and there with these data but most of them relate to their primary prevention cohort,” panelist Susan Ellenberg said in reference to patients who had not had something like a heart attack or stroke and are at a lower risk. “My feeling is that I may tend to leave it to clinical judgment about who should get” the drug.

Panelist James de Lemos was more skeptical, saying Vascepa “should be approved for secondary prevention only,” with the company needing to study Vascepa against a placebo in those lower risk patients. Jefferies analyst Michael Yee wrote earlier Thursday that the potential patient population could reach five to 15 million in the U.S., though only having one million patients on the drug would still make it a $2.5 billion medicine.

The recommendation clears a big hurdle for what could result in more than $1.5 billion in annual sales, according to Wall Street analysts, and may set up Amarin for an outright sale to a larger drugmaker looking to bolster its portfolio of heart drugs. Vascepa, which is currently sold in a more niche population of adults with severely high levels of triglycerides, could bring in more than $4 billion a year in peak sales, depending on the drug’s label, SVB Leerink estimated.

“My inclination is to let something go onto the market that does have demonstrated benefit,” panelist Anna McCollister-Slipp said in the group’s discussion period.

While the panel agreed that Vascepa’s label should be expanded, the ultimate decision of how large the potential patient population will be lies in the FDA’s hands. The wording of the panel voting question leaves the potential population to the agency’s discretion.

Read more: Amarin Judgment Day for Heart Drug Has 400% Returns at Stake

U.S. regulators are expected to make a final decision by Dec. 28, and while the agency typically heeds the advice of its panels of experts, it isn’t obligated to. Shares of the drugmaker were halted Thursday during the panel, but ended Wednesday trading at a four-month high.

The label’s wording will likely be another debate between bulls and bears, but Jefferies’ Yee sees the potential wording as having a more muted impact to consensus sales estimates. “We think it’s a good debate to have around wording of the label, but will not dramatically impact the stock either way or consensus numbers,” he wrote in the mid-day note.

The stock on Tuesday had its best session since game-changing data back in September 2018 after agency documents were seen as “generally positive” across Wall Street. Analysts told Bloomberg in an Oct. poll that shares could move more than 20% depending on the panel’s outcome and agency documents.

Short-sellers had been piling in ahead of the meeting with about $1.2 billion of shares available for trading sold short, data compiled by financial analytics firm S3 Partners showed. That’s the highest level in at least a year and more than five times the number of shares shorted in mid-December.

Micro-cap peers that are studying similar medicines surged in late trading. Acasti Pharma Inc. jumped more than 20% while Matinas BioPharma Holdings Inc. climbed 11%.

--With assistance from Michelle Fay Cortez.

To contact the reporter on this story: Bailey Lipschultz in New York at blipschultz@bloomberg.net

To contact the editors responsible for this story: Catherine Larkin at clarkin4@bloomberg.net, Cristin Flanagan, Scott Schnipper

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