Biotech Evolus gets CRL tied to its Botox rival manufacturing design

Daewoong Hyangnam plant in South Korea
The plant in South Korea that Daewoong Pharmaceutical built specifically for Evolus Botox copy has remedied issues the FDA raised in a Form 483 during its first preapproval inspection. (Daewoong Pharmaceutical)

In January, biotech Evolus warned investors that approval of its rival to Allergan’s signature drug Biotox might be delayed. It said FDA had raised questions about the contract manufacturer that will produce the biologic. It turns out Evolus was only half right.

The Irvine, California-based biotech last week said the FDA had “fully validated” the Daewoong Pharmaceutical manufacturing facility in South Korea which was built for production of DWP-450. While the plant got an OK, Evolus’ manufacturing processes did not.

The agency issued a complete response letter to the company for its  botulinum neurotoxin candidate, citing concerns about the so-called Chemistry, Manufacturing, and Controls (“CMC”) processes Evolus had established for manufacturing it.

“Overall, we view these updates as positive, which together give us the line of sight necessary to build our commercial infrastructure,” Evolus CEO David Moatazedi said in statement.

He said the company will respond to the FDA’s questions within 90 days.

RELATED: Look out, Allergan: Doctor surveys show the 'Botox competitive threat is real'

While it is bad news for Evolus, it is a positive development for Allergan which is facing a slew of contenders anxious to cut into Botox’s revenues, which were $2.3 billion in the U.S. last year and $3.2 billion worldwide.

Analysts have said that market share for Allergan’s top-selling Botox should be safe even after new competitors show up but a recent poll of 100 high-volume U.S. aesthetic physicians, suggested otherwise. The poll by analysts at Bernstein found that new entrants from Evolus, Revance  and Hugel could grab up to 34% of the market. Bernstein analyst Ronny Gal told clients a few months ago that it predicted Revance would capture the lion’s share at 18%, with the other two companies splitting a 13% share.

Since then, Mylan announced it had teamed up with Revance on a cheaper contender to Allergan’s top-selling drug.

 RELATED: Evolus says its Botox biosimilar could be delayed by FDA issues with Daewoong plant

Last week’s announcement also was good news for South Korea-based Daewoong, which built the new plant specifically to make the Evolus product. That effort seemed to be challenged in January when the FDA issued a Form 483 with 10 observations following the initial pre-inspection of the plant. But Evolus reported last week the the FDA has now issued an Establishment Inspection Report, or EIR, for Daewoong’s manufacturing facility that confirmed it had passed its most recent pre-approval inspection.