As the global expansion of domestic botulinum toxin (BTX) products is becoming visible, pharmaceutical companies are making efforts to solve quality-related issues, especially the tolerance and safety issues.
Botulinum toxins approved in Korea include Medytox’s Medy Toxin, Hugel’s Botulax and Daewoong Pharmaceuticals’ Nabota. Medytox was the frontrunner to advance into the Chinese market, and Daewoong was first to penetrate into the U.S. market.
Medytox is expected to get approval in China as early as the first quarter of next year, and Daewoong by the first half of 2019 in the U.S. Hugel is behind in the two markets but aims to win approval in both countries at about the same time. They expect sales growth of up to 1 trillion won ($888 million) in China and the U.S.
The effects of botulinum toxin decrease after a certain period through body absorption and other reasons. This is why iterative treatments are performed, and awareness is growing on its tolerance and safety. According to the pharmaceutical industry, all three locally produced BTX in the market are 900 kDa(neurotoxin+complex protein) products.
Usually, only about 150kDa of the 900kDa brings out the toxin effect. That is, 150kDa is the amount that demonstrates the desired effects of neurotoxin. The remainder is made up of the combined protein required for product composition. So, the smaller the number is, the less likely it is to develop tolerance. Reducing the dosage of the remaining complex proteins and leaving only neurotoxin can be the way to escape risks of tolerance and side-effects, which determines their future competitiveness.
In the global market, Xeomin has the highest toxin purity of 150kDA. Allergan’s Botox is 900kDa and Dysport’s is 500-750 kDa. Xeomin has maintained a premium pricing policy thanks to this advantage. There have been no reports of tolerance of Xeomin so far, according to Merz.
Among the locally produced products, Medytox’s Coretox is the only 130kDA toxin. Having excluded complex proteins and animal-derived proteins, it consists of the pure toxin. Coretox is the only one that can be the competitor of Merz’s Xeomin once it enters the global market.
Daewoong Pharmaceuticals and Hugel are also known to be preparing next-generation products. Huons, a latecomer in the market, has shown the intention to develop 150kDa products.
“Although we cannot conclude that 150kDa is more effective than 900kDa, the concept is to make products with the pure toxin by reducing other complex proteins,” said a researcher in charge of botulinum toxin. “Toxin, by its nature, is often repetitively used. Risks regarding safety or resistance are apt to follow, and we think that 150 kDa products can be a solution to reduce such risks in the future.”
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