Driven by a landmark cardiovascular outcomes trial that could spell blockbuster sales for its fish-oil derivative, Vascepa, Amarin has been a darling for pharma M&A speculators. Now, after Novartis' $9.7 billion agreement to pick up The Medicines Company, the rumor mill is back up and running.
Amarin, currently valued at around $21 per share, could be the target of a big acquisition with an FDA decision on a heart-helping label expansion for Vascepa coming late next month and prescriptions for the lipid-lowering drug on the rise.
Those buyout rumors are nothing new, but could the MedCo deal for PCSK9 candidate inclisiran last week spell a buying boom in the cardiology space? Some bullish investors seem to think so––and the most bullish believe an Amarin deal could be worth more than $20 billion.
The possible suitor list is ever-expanding, with megapharmas like Pfizer and Amgen near the top of the pile, and "dark horse" candidates like Gilead in the supposed running.
Amarin, for its part, is staying on the sideline, saying "we don't comment on rumor and speculation."
For Pfizer––which found unprecedented success marketing the blockbuster cholesterol-blaster Lipitor––the marketing dovetail might seem an obvious choice with Vascepa already approved to lower high triglyceride levels. But there could be a competitive motivation for Amgen––and Sanofi and Regeneron, for that matter––to take a hard look at Amarin, which is now on track to compete with Amgen's Repatha and the Sanofi-Regeneron team's Praluent in the PCSK9 space.
In Gilead's case, the drugmaker recently added a Vascepa cohort to a phase 2 trial in nonalcoholic steatohepatitis (NASH), leading some speculators to the conclusion that Gilead was at least considering an Amarin buyout. Assuming positive top-line results for that combo treatment, which includes Gilead's cilofexor and firsocostat, having Vascepa on board could give Gilead the inside lead on the multibillion-dollar NASH market.
Of course, all of those narratives are complicated somewhat by Amarin's stated plan to flesh out its own marketing team in anticipation of Vascepa's label expansion and attempt to go it alone.
In July, CEO John Thero told investors Amarin was prepared to take on the increased demand for Vascepa with a sales hiring goal of 800 employees and a planned direct-to-consumer advertising campaign upon expansion. The drugmaker said the company expects to reach 70,000 to 80,000 healthcare professionals when its sales force is fully fleshed out and is seeing higher-than-expected access to doctors in the meantime.
That expansion plan was put on temporary hold after the FDA called an advisory committee to review Vascepa's application, but that committee unanimously voted two weeks ago to recommend the expansion. The FDA is set to hand down a decision on Vascepa by Dec. 28.
Some investors have also expressed skepticism that Vascepa––derived from Omega-3 fish oil––would be worth the multibillion investment given the IP challenges it's already facing from generics makers like Dr. Reddy's Laboratories. Cantor analyst Louise Chen, however, argued that Amarin would likely reach patent settlements with those challengers to put off competition to the late 2020s.
Vascepa's new label––if approved––would allow Amarin to market the drug's heart helping results after a CV outcomes study released in late 2018 showed the Omega-3 derivate on top of statins cut the risk of major cardiovascular events by 25% over statins alone.
Earlier this month, Amarin backed up that outcomes data with its Evaporate imaging study showing Vascepa slowed the progression of arterial plaque buildup across the board. That data, which helped to explain Vascepa's mechanism of action, could give physicians more confidence in the drug if its label expansion is approved, according to Amarin CMO Craig Granowitz.
Editor's Note: This story has been updated.