April 26, 2024

• 

[THE INVESTOR] Daewoong Pharmaceutical said on Aug. 20 it has received marketing approval from Canadian health authorities in less than a year after it applied for one for its botulinum toxin Nabota.

With the decision, Nabota will become the first such drug developed by a Korean firm to enter Canada. 

In July last year, Daewoong filed for regulatory approval for the Botox-like injectables for treating glabellar lines. Shares of Daewoong rose 2.89 percent on the announcement.

“Receiving the authorization so soon in Canada gives us a significant indication that the quality, safety and efficacy of Nabota have been firmly proven by an advanced country,” said Park Sung-soo, business manager of Nobata.

Daewoong plans to begin selling Nabota by the first half of 2019 through Clarion Medical, a partner of Evolus, which has an exclusive distribution license to market it in the North American market from Daewoong. Clarion Medical is an Ontario-based company which provides equipment to hospitals, aesthetic clinics and private medical practices, ranging from laser to skin treatments, fillers and intra-ocular lenses.

Daewoong also expects Nabota to be commercially launched in the US and Europe before June next year, ahead of its rival toxin makers Medytox and Hugel.

“We hope to accelerate overseas business expansion in North America, which is the biggest toxin market,” Park said.

Currently, Daewoong is awaiting approval from the US Food and Drug Administration after its local partner Evolus resubmitted its biologic license application for Nabota on Aug. 2.

The resubmission follows the receipt of a Complete Response Letter from the FDA, which thwarted Daewoong’s hopes of bringing Nabota to the US market within this year. The FDA notified Evolus in May that the agency had suspended the approval review, citing deficiencies in biologic license application related to chemistry, manufacturing and control processes.

“We are in the last phase efforts to make inroads into the US market while regulatory procedures with the European Medicines Agency are going smoothly,” a company official said.

By Park Han-na (hnpark@heraldcorp.com)