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

The FDA issued a Form 483 to the Daewoong Hyangnam plant in South Korea after a pre-approval inspection for Evolus' Botox biosimilar. (Daewoong Pharmaceuticals)

Some Allergan investors have felt queasy about the potential for Botox knockoffs to suck up some of the company’s bottom line. But manufacturing issues for one of those players, Evolus, could delay approval of its candidate.

The Irvine, Calif.-based biotech raised that spectre in a filing with the SEC for a public offering to help pay its ongoing costs to get its botulinum neurotoxin candidate, DWP-450, to market. It said that following the FDA pre-approval inspection of the Daewoong Pharmaceutical plant in South Korea that will make its  product, the agency issued a Form 483 with 10 observations.

RELATED: Evolus plans $75M IPO to bring Botox biosimilar to market

The contractor assured Evolus that it has the situation in hand and expects “no significant further actions” from the FDA. But as Evolus astutely points out, there are no guarantees of that, and if the FDA makes Daewoong take additional corrective actions, go through a reinspection or decides not to approve the drug candidate for now because of manufacturing concerns, then approval of its candidate could be delayed.

A highly redacted copy of the Form 483 shows the FDA noted a number of issues during its November inspection. The FDA raised concerns about the extent of the Daewoong plant’s investigation into black particles found in some batches of the sterile drug candidate, as well as its endotoxin method verification and its monitoring of aseptic process areas. There was also an observation about the potential for employees to access some computer programs and potentially alter or delete data.

In a note to Allergan investors Wednesday, Wells Fargo analyst David Maris, after acknowledging his group are not pharma manufacturing experts, said, “Based on our experience, it seems the observations are serious.”

It will be known soon enough, because the PDUFA date for Evolus’ neurotoxin is May 15.

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

Regardless of the manufacturing issues, Maris said he does not believe Allergan’s Botox will see much competition from “Botox knockoffs (which we call faux-tox),” if their only advantage is a cheaper price. The analysts believes patients and doctors will stick with the brand-name drug.

That said, a recent survey by Bernstein analysts suggests otherwise. The poll of 100 high-volume U.S. aesthetic physicians found that forthcoming entrants from Evolus, Hugel and Revance could grab up to 33% to 34% of the market, Bernstein analyst Ronny Gal wrote to clients recently. Revance would capture the lion’s share at 18%, with Hugel and Evolus splitting a 13% share, according to the results. Botox brought in more than $2 billion in sales globally through the first nine months of 2017.