Evolus, which had its Botox rival sidelined by the FDA in May over CMC concerns, believes it has its manufacturing figured out and says it is back on track with an action date.
The Irvine, California-based biotech Wednesday announced the FDA had accepted its BLA resubmission and assigned its drug candidate DWP-450 a Feb. 2, 2019, PDUFA date.
“We have worked diligently to advance our regulatory submission for DWP-450. With this notice from the FDA we remain on track to launch commercially in the U.S. in Spring 2019,” Evolus CEO David Moatazedi said in a statement.
He added that the company was continuing the development of a sales and marketing strategy for DWP-450.
In January, Evolus warned investors that approval of its rival to Allergan’s signature drug Botox might be delayed because the FDA had raised questions about Daewoong Pharmaceutical's manufacturing facility in South Korea built expressly to manufacture DWP-450. Things took a twist in May when the FDA fully validated the plant but issued a complete response letter (CRL) to the company citing concerns about the so-called Chemistry, Manufacturing, and Controls (“CMC”) processes Evolus had established for manufacturing it.
Evolus’ botulinum neurotoxin candidate is one of several vying for approval and a piece of the $3.2 billion in annual revenues Allergan’s blockbuster generates. Best known as a wrinkle remover, Botox has also been approved for treating a host of other conditions including cervical dystonia, chronic migraine and severe underarm sweating when antiperspirants fail. Second-quarter sales of the drug grew 14.5% to $985 million.
Mylan is one of those aiming at Botox and earlier this year teamed up with Revance, which was already developing its own version.
Bernstein analyst Ronny Gal called Mylan's deal a "smart move" while pointing out that Botox will not be easily copied.
“Both development and manufacturing of toxins are highly complex and heavily regulated, and Mylan has not developed biosimilars in-house yet (all partnered). The partnership with Revance brings them the capabilities they need,” he wrote to clients when the hookup was announced.