Korean makers of botulinum toxin are likely to compete against one another in the global market next year, industry watchers said Tuesday.
Daewoong Pharmaceutical, Medytox, and Hugel will vie for a larger market share in the U.S., and Medytox and Huons, in China. The four Korean companies have selected local partners in the U.S. and China for distribution channels, waiting for approval as the last stage.
Daewoong, Medytox, and Hugel are targeting the U.S. market, estimated to be about 2 trillion won ($1.7 billion).
Among them, Daewoong is moving the fastest.
Recently, the U.S. regulator has resumed reviewing Daewoong’s botulinum toxin Nabota. Earlier, the drugmaker had filed a supplementary data with the U.S. Food and Drug Administration as a follow-up measure to the Complete Response Letter received from the FDA.
Considering that the U.S. review takes six months, whether the FDA will give Nabota the nod will be determined in February next year.
Daewoong chose U.S. firm Evolus, comprising of local physicians, as a partner for Nabota sales.
Although coming late in the U.S. market, Medytox has become a strong rival against Daewoong. Medytox’s partnership with Allergan, the maker of the original Botox, has given the Korean firm a considerable edge. Botox is the leading botulinum toxin in the U.S. concerning market share.
In a recent conference call, Allergan named Medytox’s another botulinum toxin product Innotox as the next business item.
Allergan mentioned Medytox as the developer of Innotox, which Allergan will sell, and announced that the company would commercialize Innotox in 2022.
Aiming to sell Botulax in the U.S., Hugel recently said it would establish a U.S. subsidiary Hugel America. The U.S. unit will be a joint venture between Hugel and Austrian partner company Croma-Pharma GmbH.
Croma-Pharma has the sales rights of Botulax in the U.S. and Europe. The esthetics-specializing company has subsidiaries in Australia, Brazil, Canada, France, the Netherlands, Poland, Portugal, and Spain.
Hugel might be late in entering the U.S., compared to Daewoong and Medytox. However, its entry in the European market will be swift with the help of Croma-Pharma, observers said.
China is another continent for a botulinum toxin battle among Korean firms.
The botulinum toxin market in China is estimated to be 400 billion won, four times larger than that of Korea. Including a shadow market, the actual size could be nearly 10 trillion won in China, officials said.
Medytox has been the speediest among Korean firms in preparing to sell botulinum toxin in China. The company has completed the phase-3 study and sought the regulatory approval for sales in February.
Only two botulinum toxin products obtained approval in China – Botox by Allergan, and BTX-A by Lanzhou, a Chinese firm. As the two products are expensive, Medytox’s low-price strategy will easily penetrate the Chinese market, observers said.
Bloomage BioTechnology, the Chinese partner firm for Medytox, reportedly calculated the first supply of Meditoxin at a considerable level.
Huons is also planning to enter the Chinese market. The company has signed a deal with local aesthetics company Imeik Technology Development to supply Hutox exclusively for 10 years after approval.
Medytox and Huons quickly selected Chinese partners due to the Chinese authorities’ crackdown on the underground botulinum toxin market.
As the Chinese government aggressively searching for irregularities, failing to obtain approval will become a significant hurdle for market entry in the future.
“We will see visible results of botulinum toxin makers’ performances from early next year in the U.S. and China. Whether they will build additional plants will be a signal that their products sell well,” an official at a drugmaker said. “The companies will announce more detailed plans such as targeting the U.S. with a therapeutic purpose, and China with cosmetics.”
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