The lowest court's recent ruling favoring Medytox in a civil lawsuit against Daewoong Pharmaceutical regarding the source of the latter's botulinum toxin (BTX) strain is causing ripples across the botulinum toxin (BTX) industry.

Daewoong and its foreign BTX partners, such as Evolus and AEON Biopharma, have all issued statements that the court's ruling will not affect their business.

Daewoong, which immediately announced its plans to apply for suspension of execution and appeal, sent out an additional press release stating that the decision would not affect its overseas sales.

"The civil judgment of the Seoul Central District Court does not affect the production, export or overseas sales of Jeuveau or Nuceiva (domestic product name: Nabota)," Daewoong said in a statement.

Daewoong cited the agreement between Medytox and Evolus as evidence behind their judgment.

Evolus outlined a similar statement stating that the recent ruling by the Seoul Central District Court does not affect Evolus' ability to have Jeuveau or Nuceiva manufactured and exported by Daewoong or to sell the products in any of its markets.

"As part of Evolus' global settlement with Medytox in February 2021, the parties resolved all litigation between the two parties and specifically stated that any Korean litigation between Medytox and Daewoong would not affect the supply of Jeuveau or Nuceiva," Evolus said. "The rights granted to Evolus under the settlement include the right to have Jeuveau and Nuceiva manufactured and exported by Daewoong to Evolus and for Evolus to continue commercializing the product."

AEON Biopharma, Daewoong's exclusive partner with the right to license, import, and sell Daewoong's BTX Nabota, also known as ABP-450, for therapeutic purposes in the U.S., Europe, and Canada, also said that the ruling will not affect its ongoing clinical development or planned commercialization strategy for ABP-450 injection in target markets.

"As part of AEON's global settlement with Medytox, which was entered into on June 21, 2021, all outstanding litigation relating to Medytox's strain of C. botulinum between the two parties was fully resolved under confidential terms," AEON Biopharma said. "The settlement contemplates that any Korean litigation between Medytox and Daewoong would not affect the supply of ABP-450 to AEON."

The company stressed that such rights granted to AEON under the settlement include having ABP-450 manufactured and exported by Daewoong to AEON, and for AEON to continue its planned clinical development and, if approved by government regulators, commercialization of ABP-450.

The problem is that Daewoong was not included in the agreement, and even if Evolus could sell overseas, Daewoong Pharmaceutical, which is in charge of manufacturing the product, was ordered by the court to stop manufacturing.

The agreement between Medytox, Evolus and AEON Biopharma, all stipulates that Daewoong has the right to manufacture and export Nabota to Evolus and AEON Biopharma, regardless of the outcome of the first trial.

However, it is unclear if Daewoong's right to manufacture will still be allowed with the new court ruling.

Due to the court ruling, Evolus and Medytox may have to conduct additional renegotiations.

According to the settlement agreement unveiled by Evolus, the two parties had agreed to renegotiate in good faith any provision held to be invalid, illegal, or unenforceable, it being the intent of the Parties that the basic purposes of the agreement are to be effectuated.

Korean BTX makers rush to distance themselves from the ruling

Korean BTX makers, such as Hugel and Huons Biopharma, also drew a line by saying that they had nothing to do with the lawsuit between Medytox and Daewoong Pharmaceutical.

The comments from local BTX makers follow Medytox expressing their intention to continue disputes over the source of the strain with botulinum toxin developers after the lowest court ruling favoring Medytox.

Medytox has continuously raised suspicion about the BTX strain origins of some Korean BTX companies, which have all claimed that they had secured the strain in a natural state.

Daewoong had said that they extracted BTX strains from the soil of a stable in Yongin, Gyeonggi Province, Hugel from rotten canned food, and Huons, which received a BTX strain from Biotopia (currently Huons Natural), from several soil samples in Korea.

In Korea, Medytox and Jetema are currently the only two companies that have officially received verification for the acquisition of their strains has been officially confirmed.

Medytox received a distribution of strains from the University of Wisconsin, and Jetema obtained its strain under a commercial license agreement with a Public Health England (PHE) affiliate.

"We will review additional legal measures against companies that illegally acquire and commercialize our botulinum strains and manufacturing process," a Medytox official told Korea Biomedical Review after the ruling.

In response, Hugel, which is currently embroiled in a U.S. International Trade Commission dispute over the origin of its strain with Medytox, also issued a statement stating that the lawsuit between Medytox and Daewoong Pharmaceutical is completely unrelated to Hugel.

"Therefore, the outcome of the lawsuit between Medytox and Daewoong Pharmaceutical cannot be any obstacle to our ongoing lawsuit against Medytox in the U.S.," Hugel said.

Huons Biopharma also stressed that the company has nothing to do with the lawsuit involving Daewoong and Medytox.

"We have strains with clear genetic characteristics and biochemical characteristics," Huons Biopharma said.

A Huons Biopharma official stressed that the entire gene sequence of the strain disclosed in 2016 by a company (Medytox) that is raising the issue of stealing the strain reveals 3,760,572 gene sequences."

"However, the total genetic sequence of our strains is 3,841,354, with a difference of 80,782 genetic analysis," he said. "The two strains have more than 2.1 percent different gene sequences, so they cannot be regarded as the same strain scientifically."