Evolus’ $EOLS attempt to field a rival to Allergan’s Botox has run into problems at the FDA.
The biotech announced Wednesday morning that the FDA has handed the company a complete response letter for DWP-450 (prabotulinumtoxinA). But the executive team quickly pinned the blame on manufacturing issues, saying they can bat their revised application back to regulators in 90 days.
The biotech’s statement starts with an announcement that the FDA has confirmed “the favorable completion of its pre-approval inspection of Daewoong’s manufacturing facility in South Korea which was purpose built for production of DWP-450.” They go on to say that despite the rejection, they’re staying upbeat — regardless of what investors might think.
And they weren’t nearly as upbeat as management. The biotech’s stock plunged 30% on the news.
CEO David Moatazedi — an Allergen vet who took the job just a little more than a week ago — says the rejection has nothing to do with data, statistics, safety or pharmacology of their product. “The remaining questions are manageable,” he told investors on a call this morning.
The biotech signaled at the beginning of the year that it had some serious manufacturing issues to deal with after the FDA issued a heavily redacted report on their inspection of the facility.
But the company declined to get specific, even after being pressed by Wells Fargo analyst David Maris.
“Obviously it’s a confidential document so we’re not going to give granularity,” noted CMO Rui Avelar.
The company says that it will get a Type 2 review for the revised pitch, setting up timeline for a planned launch next spring.
“We’ve largely de-risked the clinical development program,” says the CEO. “The pathway to commercialization is now clear” after the feedback. And Moatazedi adds he’ll start scaling for a commercial launching 2019.
He declined, though, to get into the specifics of the FDA’s questions.
“We are pleased with the progress we continue to make with the FDA, and this CRL confirms our confidence in our clinical submission,” said Moatazedi in a statement. “Deficiencies cited within the CRL are isolated to CMC matters and we expect to respond comprehensively within 90 days. Overall, we view these updates as positive, which together give us the line of sight necessary to build our commercial infrastructure. We look forward to working closely with the FDA and remain committed to bringing DWP-450 to market by spring 2019.”
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