Amarin gets a boost from the FDA as regulators promise speedy Vascepa decision — but what about that panel review?
There’s plenty of buzz today about Amarin $AMRN and its quest to get cardio outcomes data added to the label for Vascepa, its therapeutic strength version of fish oil.
The FDA has given their sNDA priority review status, leaving a decision on opening up the market for this therapy just 4 short months away on September 28. The move lops months off the regulatory process and moves a potential approval into Q3 of this year — one of the biggest catalysts on the H2 calendar.
That’s a very big deal for Amarin, which managed to wow just about everyone with its 25% reduction in the risk for the first occurrence of a major cardio event in their target population, the primary endpoint that has sparked buzz about a potential takeover — though one has yet to materialize.
As an excited Michael Yee at Jefferies noted today, Amarin CEO John Thero is staying conservative in anticipating a panel review. But as Amgen got a pass on PCSK9 CV outcomes, he’s 50% to 60% certain there won’t be a panel — which would be the final de-risking event that would pave a likely approval here.
Here’s the biotech’s rather dry summary:
Amarin previously expressed that it believes an AdCom meeting organized by the FDA in conjunction with its review of the expanded label for Vascepa is likely, as this will be the first ever drug approved for the large patient population studied in the REDUCE-IT trial. It is not uncommon for the FDA to provide clarification later in the process on whether an AdCom will be held.
Setting aside some of the wilder projections, the new peak sales estimates for Vascepa are now in blockbuster terrain, which is why so many investors have bet on a buyout. On the other hand, this is a tough market to capitalize on, as Amgen and Regeneron learned the hard way with PCSK9. And that could give buyers cold feet in any negotiations tied to big sums in a seller’s market when it comes to late-stage and approved drugs.
Investors liked the sounds of progress today, though, bidding up shares by 5% while betting on the likelihood of an approval. And Yee is also counting the money as they wait on the FDA. He notes:
The scripts continue to go higher each week despite any label expansion yet. We believe this is a testament to the strong CVOT data publicly presented and published already, and the demand by patients and docs and ease in reimbursement – per our numerous doc checks. We think Q2 is likely to be a strong quarter (into the $90M+ and up from $77M in Q1) and this strong trajectory would put them possibly on track to beat 2019 guidance of $350M this year.
Image: Andrew Harnik AP