Medytox on Monday said its botulinum toxin (BTX) strain formed spores when tested according to the Daewoong Pharmaceutical way, in yet another turn amid the ongoing legal battle between the two firms.
Medytox alleges Daewoong stole its BTX strain and trade-secret separation and purification method through a former Medytox employee who joined Daewoong.
The firms have ongoing suits in Korea and the US.
Daewoong’s BTX Nabota is making inroads to the US and Europe, under the names Jeuveau and Nuceiva, respectively. Medytox’s Meditoxin, known as Neuronox in China, is expected to gain sales approval there within this year.
The US’ International Trade Commission had received spore-formation test results from Medytox on Sept. 20 as burden of proof, while Daewoong alerted the media of its own test results of its BTX strain.
Medytox had previously claimed that Daewoong’s BTX is a Hall A Hyper strain BTX identical to its own that would not form spores. However, Daewoong says its BTX, tested by the USITC-approved expert in the method both firms agreed upon a year ago, has indeed formed spores. This is proof that Daewoong’s BTX is an original finding separate from Medytox, the company has said.
In a follow-up, Medytox now contends that Daewoong has employed a completely new scientific method that makes Hall A Hyper strain BTX form spores.
After having tested its own Hall A Hyper strain BTX using the Daewoong method, Medytox’s BTX also formed spores, the company said Monday. This upends the formerly known academic literature and findings that Hall A Hyper BTX have never been known to sporulate.
Upon this report from Medytox, a Daewoong representative downplayed the Medytox’ claims.
“Medytox may be risking its business by raising the possibility that its own BTX is not Hall A Hyper strain as specified in all its official documents for the Meditoxin,” the Daewoong representative said.
Daewoong is of the position that it discovered its BTX from soil in Gyeonggi Province, Korea, and that it had initially promoted the BTX to have similar qualities to the Hall A Hyper toxin but that it never outright said it is Hall A Hyper strain.
Medytox says it acquired its BTX from the University of Wisconsin.
Medytox is currently demanding Daewoong to reveal the DNA sequence of its BTX for direct comparison.
“Our unchanging message is for Daewoong to reveal the DNA sequence of its botulinum toxin and be done with this dispute for good,” said a Medytox representative.
A Daewoong representative said the company is scheduled to submit the DNA sequence to the USITC in mid-October under confidentiality conditions.
After the initial expert reports submission made by both parties on Sept. 20, the evidentiary hearing is likely to take place Feb. 4-7, 2020.
The final initial determination on the alleged violation is due on June 5, 2020 with the completion of investigation tentatively set for Oct. 6, 2020.