Daewoong Pharmaceutical Announces Successful 'Extra Strength' Results of US Phase 2 Clinical Trial for High-dose Administration of NABOTA

Wed, 08 Nov 2023 11:26:00 +0800

• High-dose Jeuveau, with a dosage double that of the existing 20 units, has succeeded in Phase 2 clinical trials as 'Extra Strength'
• Demonstrating a proven long-term efficacy of 6 months—double the treatment cycle of competing products—Jeuveau enhances global product competitiveness

SEOUL, South Korea, Nov. 8, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is proud to announce the successful completion of a Phase 2 clinical trial for its botulinum toxin type-A product, NABOTA, commercially known as Jeuveau in the United States. This pivotal trial achieved its primary endpoint, demonstrating that a high dose of 40 units of Jeuveau can effectively treat glabellar lines with long-term efficacy lasting up to 26 weeks, or 6 months.

The Phase 2 study, focusing on "Extra Strength" treatment for glabellar lines, was a multicenter, double-blind, randomized trial conducted across five study sites in the United States. It involved 150 participants with moderate to severe glabellar lines, as assessed by the subject and medical professionals using the Glabellar Line Scale (GLS).

These findings mark a significant achievement for Daewoong Pharmaceutical and its partner, Evolus. The results were presented at the prestigious American Society for Dermatologic Surgery (ASDS) conference in Chicago on October 3rd.

Sung-Soo Park, Vice President of Daewoong Pharmaceutical, commented "The conclusive results from the high-dose administration in the Phase 2 clinical trials by our partner Evolus are noteworthy. We are poised to enter and compete in major botulinum toxin markets, including the United States, Europe, Canada, and Australia, leveraging our global competitiveness." He further emphasized the commitment of both companies to "continuously validate the efficacy and safety of NABOTA through ongoing clinical trials and to increase our market share worldwide."

NABOTA, which contains Botulinumtoxin Type A and is the first FDA-approved botulinum toxin from Asia, has been experiencing consistent growth. Through its partnership with Evolus, it has expanded its global reach. In Europe, where it is known as NUCEIVA, the product has been successfully launched in the UK, Germany, Austria, and Italy, reinforcing its strong market presence in both North America and Europe.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.