Vanda shares slide after FDA spurns their big endpoint and rejects a pitch on jet lag relief
Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.
Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.
The FDA batted back their supplemental application, the company announced Monday morning, saying “these measures demonstrating improved sleep are of unclear clinical significance.”
The CRL contains additional observations on various aspects of Vanda’s sNDA.
But we don’t know what those are. And now the biotech’s execs plan to follow up with the agency to better define the predicament they’re in.
The stock slid 13% on the news, evidently failing to surprise a large number of investors — or analysts.
Stifel’s Derek Archila joined a group of skeptics wondering what, if any, kind of market Vanda could have expected, given its sky-high orphan price on the drug.
It is unclear what the next steps are for this program from a timing/clinical perspective, but our view on JLD has been whether or not this is a commercially viable indication for VNDA to develop Hetlioz for. Given Hetlioz’s orphan pricing in Non-24, we had estimated the cost for 3 days of therapy for JLD would have been approximately ~$1,500, much higher than OTC and/or Rx sleep products which are typically used. For this reason, we did not include any value for this program in our model.
“We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program,” said Polymeropoulos in a statement. “Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need.”