Hugel said a complete response letter (CRL) from the U.S. FDA on botulinum toxin (BTX) Letybo requires supplementary documents, but it would not have a significant impact on the drug approval.
News reports said that Hugel received the FDA’s CRL on Letybo (brand name in Korea: Botulax) on March 31.
Hugel applied for marketing approval for Letybo to the FDA in March 2021 and received an inspection on BTX factory Geodu Plant, located in Chuncheon, Gangwon Province, in August 2021.
A CRL is an outcome of the FDA review on Biologics License Applications (BLA) or New Drug Applications (NDA). The FDA issues a CRL to require additional field inspection or supplementary data. If a company receives a CRL, it must apply for approval again. Thus, receiving marketing approval after getting a CRL takes some time.
“We cannot disclose the detailed content of the CRL,” an official at Hugel said. “But it is a ‘minor’ issue related to document supplementation. Therefore, it will not affect approval.”
As the FDA completed the on-site inspection last year, he added that a re-inspection is not necessary.
In a press conference earlier this year, Hugel said it would enter China, Europe, and the U.S. with its BTX product within this year.
However, the CRL made it uncertain whether it could enter the U.S. market this year.
Analysts said Hugel’s receiving of the FDA’s CRL would delay the launch of Letybo in the U.S. for at least five months.
In a report on Monday last week, which was titled, “It’s time to set the standards lower,” Kyobo Securities said Hugel received the FDA’s CRL on Letybo on March 31, as the company expected the FDA’s conclusion by March 31 under the Prescription Drug User Fee Act (PDUFA).
The brokerage predicted that it would take about three months for Hugel to re-submit the application to the FDA and another two to six months to receive approval.
Kyobo Securities forecast that Hugel’s sale of Letybo in the U.S. would start in the first half of 2023.
The brokerage lowered the target stock price of Hugel from 190,000 won ($154) to 130,000 won.
An industry official said it was almost impossible for outsiders to know what the FDA requested in the CRL.
“Only the internal officials will know whether it is a serious defect or a problem that can be resolved,” the official said.
He added that a CRL means almost “approval rejection,” and issuing a CLR means the FDA cannot grant marketing approval with the submitted documents.
On Thursday, Hugel said in a public disclosure that it repurchased its stock worth 50 billion won to elevate shareholder and corporate value and stabilize the stock price. The company said that the share repurchase agreement with Samsung Securities would be valid from April 7 to Oct. 6.
“Although the company is about to become a global company, the stock price has fallen due to external factors. As a result, it is excessively undervalued, compared to the actual company’s value,” Hugel said. “We decided to repurchase treasury stock to express our commitment to responsible management based on our conviction for long-term growth and to enhance corporate value.”