For years, Amarin promised that its fish-oil derivative Vascepa could offer big results in cardiovascular benefits and evolve into a blockbuster. Now, with the FDA fast-tracking review of the drug’s label expansion, analysts are seeing major sales on the horizon.
The FDA placed Vascepa under priority review this week, speeding what could be the first approval to reduce the risk of CV disease in patients previously treated with statins for high LDL cholesterol with elevated persistent triglycerides. The agency's decision deadline is set for Sept. 30, four months earlier than expected, the company said.
And sales-wise, it's getting prepared. “We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy,” Amarin CEO John Thero said in a press release. “Our plans to significantly expand promotion of Vascepa following label expansion are being accelerated to reflect the upcoming PDUFA date."
With Vascepa on the express lane to approval, Wall Street is showing increased confidence in Amarin, with analysts increasingly impressed by the drug’s sales promise. On Wednesday, Amarin’s share prices jumped from $17.01 per share to $19.64 on the heels of the FDA news, an eye-popping 15.5% increase. By market close Wednesday, that price evened out to $18.99 per share.
Vascepa’s strong showing in the phase 3 Reduce-It trial, data from which rolled out in September, could lead to a peak share price of $35 in the next year, Cantor Fitzgerald analyst Louise Chen said in a Thursday note to investors. While the FDA did not say whether it would call an advisory committee meeting to review Amarin’s application, Chen said company execs are hopeful the committee hearing will help provide even more backing for the drug’s CV benefits claims. Vascepa’s Reduce-It data, filed with the FDA in March, showed Vascepa lowered the risk of a major adverse CV event by 26% in previously untreated patients compared with placebo, and by 30% in statin-treated patients at a median follow-up of 4.9 years.
“We think the general sentiment is that an (advisory committee) could be a positive for Vascepa, for example by emphasizing that (Reduce-It) is a validation of Vascepa and not of triglyceride-lowering medications,” Chen wrote.
Jefferies analysts, for their part, have pegged Amarin's peak target on the year at $30 per share, citing continued uncertainty around patent lawsuits filed by Hikma and Dr. Reddy's Laboratories to launch Vascepa generics, they wrote in their own note to investors in late April. With a tentative trial date set for January 2020, analysts said a possible settlement could put off generic launch until 2029 and not significantly hurt Vascepa's sales in the short term.
"It is far more interesting for a generic company to have a generic launch later in 2029 when a drug could be $5B, not in 2021 (or later) when the branded drug is $1B and has not had time to grow yet," the analysts wrote. "In our view, generic companies probably understand this concept."
In the meantime, Amarin can point to Vascepa’s growing uptake as a sign of physicians' interest in the drug’s results.
By the first week of May, Vascepa’s total prescriptions had jumped 67.1% over the previous year, with new scripts growing by an even larger 76.8%. In a survey of 50 physicians, Cantor said doctors already favored prescribing the drug, with only 23% saying they would wait for a label expansion. That support and a label expansion could lead to a significant boost in Vascepa’s sales in 2019, Chen said, potentially even taking them past Amarin’s forecast of roughly $350 million.
With everything coming up aces for Vascepa, Amarin has had to fight off challengers over its trial results. Earlier this month, Amarin settled with two fish-oil supplement makers it claimed piggy-backed Vascepa’s trial data to promote their own products. Following the settlements, Amarin said it has lawyers “on speed dial” in case more supplement makers decided to take a run at the drug’s data.