Merz Aesthetics is enhancing a competitive edge in the botulinum toxin (BTX) market after the approval of its BTX brand Xeomin for storage at room temperature.

Merz held a press conference on Thursday celebrating the Ministry of Food and Drug Safety's approval of Xeomin as the only BTX product in Korea that can be stored at room temperature (1-25℃).

Xeomin, launched in 2005, has been approved by the Ministry of Food and Drug Safety (MFDS) for its efficacy and safety in three areas -- glabellar lines, eye, and forehead wrinkles.

According to the company, a BTX product, which is classified as a biological agent, must ensure consistent effect expression and stability at 1-25°C to obtain permission for storage at room temperature.

Citing clinical studies, Merz confirmed that Xeomin's biological activity and human serum albumin content remained constant for 36 months at a temperature of 25°C and a humidity of 60 percent.

"BTX helps improve the quality of life of patients for therapeutic and cosmetic purposes, but it is a powerful toxin that can also be used for bioterrorism," Professor Huh Chang-hoon of the Department of Dermatology at Seoul National University Bundang Hospital said during the conference. "Therefore, transparent strain sources and manufacturers' ethical awareness are important matters directly related to national security."

Huh stressed that there are too many companies selling BTX products in Korea, and there are a lot of misuses.

"Even if the initial germs are the same in making a BTX product, the contents change during the manufacturing process, so it is necessary to judge the product with three factors -- purity, consistency, and stability," Huh said. "In that sense, the MFDS' approval of Xeomin's storage at room temperature is very significant."

Professor Kim In-gyu at Yonsei University's Korea National Institute for Bioprocessing Research and Training Center gave a lecture on domestic biologic-related regulations.

The U.S., Germany, and Japan have established strict management systems for biological agents such as BTX through continuous management and supervision, but Korea's system is insufficient, Kim said. 

In Korea, the safety issue of BTX continues to emerge, and through the revision of the Infectious Disease Prevention Act, Korea will move towards supplementing the shortcomings of the pathogen management system and strengthening safety management, he said.

Apgujeong Oracle Dermatology Director Park Je-young explained the significance of Xeomin's room temperature storage permission and the safety and features of this Xeomin through clinical data.

"Xeomin, which already received approval in the U.S. and EU to be stored at room temperature, isolated active neurotoxins through chromatographic techniques, a high-level manufacturing process that separates complex proteins that cause resistance," Park said. "Approval for room temperature storage means that there is little risk of decomposition or deterioration of products that may occur due to temperature changes during transportation or distribution."

Park stressed that Xeomin also reduced the possibility of developing BTX resistance, which gradually decreases effectiveness with repeated treatments.

"This approval from the MFDS reaffirms the excellent quality of Xeomin, and I hope that interest in Xeomin will lead to awareness of the safety and resistance of BTX," Park said.