This time six years ago a heavily indebted Amarin, whose market cap had been crushed to a tiny $250m, was waiting for the FDA to turn down its application to market Vascepa to a bigger patient population. Fast forward to 2019, and the picture could not look more different.
A unanimous vote by an FDA advisory panel yesterday almost guarantees a broader label for the purified fish oil product, and the big remaining question is just how many patients the regulator is prepared to include in any new indication. With a decision due just before the end of the year, the wait to find out will soon be over.
The use of mineral oil as a placebo was considered one of the big issues heading into the adcom but in the event the panellists judged it unlikely to have influenced the findings of the Reduce-It study (Vascepa's future could hinge on next week's panel, November 5, 2019).
The main focus of the assembled experts was instead whether Vascepa’s new indication should be restricted to a secondary prevention setting, meaning only patients with established cardiovascular disease. Less than a fifth of the 8,000 subjects recruited into Reduce-It fitted a primary prevention description – those considered at risk of future cardiac problems – and the benefit of Vascepa was much less pronounced in this cohort.
As such, the FDA could have reason to err on the side of caution. Even so, the panel was not particularly concerned about safety flags like atrial fibrillation or bleeding, with some panellists advocating an all-encompassing label.
For now, most sellside analysts are modelling revenues in a restricted population, with peak numbers sitting at around $4bn. This implies a net present value for Vascepa of around $8bn, according to EvaluatePharma’s NPV Analyzer, pretty much where Amarin’s market cap is today.
Shares in the company, which have surged more than sevenfold since Reduce-It surprised by reading out positively, edged 6% higher this morning.
How exactly Vascepa bestows its cardioprotective qualities remains unanswered, and perhaps this is another reason why the FDA might decide against a very broad label. Amarin has not announced any plans to study the drug in a primary prevention setting, and with Vascepa patents only running to around 2029 in the US there is probably little reason for a commercial company to run such a trial.
A small academic study being presented as a late-breaker at the American Heart Association’s annual meeting over the weekend will make interesting reading, however. The Evaporate trial looks at Vascepa’s ability to stabilise artery plaques, having recruited statin-treated patients with atherosclerosis, and is measuring changes in plaque volume in subjects treated with Vascepa or placebo.
A strong finding here would only add to the Vascepa story, which has provided biopharma watchers with a riveting ride over the past decade. It’s not over yet, though it certainly no longer looks like a disaster movie. Indeed, many will be hoping that the tale has the ultimate happy ending: a buyout.