South Korea’s biggest botulinum toxin maker Medytox and its smaller rival Daewoong Pharmaceutical are stepping up their accusations against each other as the two are set to soon begin a legal fight in South Korea over the source of their BTX strain.

Since last year, Medytox has claimed that Daewoong stole its BTX bacterial strain and related manufacturing secrets to develop its Type BTX Nabota. The issue was taken to court in the US in July this year, as Medytox filed a civil lawsuit in California against Daewoong and its US partner Alphaeon Corp.

Daewoong has strongly denied the allegations, labeling them as a groundless campaign by Medytox to damage the reputation of Daewoong which is preparing to enter the US market with Nabota.

Daewoong submitted Nabota for regulatory approval by the US Food and Drug Administration in June. If approved, Nabota would become the first Korea-developed BTX to hit the US market. Medytox’s liquid-type BTX -- licensed out to Allergan in 2013 -- has completed only phase 2 clinical trials in the US.

This month, the Superior Court of California in Orange County ruled that the Medytox-Daewoong dispute should be settled in Korea, where the fight initially emerged, citing plans to review the case again on April 13, 2018 after a decision by Korea’s courts.

As Medytox prepares to file a formal lawsuit against Daewoong in Seoul this week, Daewoong waged another public attack against Medytox and its “dubious” BTX bacteria import pathway.

“Our BTX strain and its origins have already passed multiple government inspections, rendering the case closed. Even if Medytox were to file a lawsuit in Korea, it would not influence us much,” Daewoong said in a statement Wednesday.

“On the other hand, the source of Medytox’s BTX has never been properly inspected, other than the firm’s claim that it was brought from the University of Wisconsin-Madison,” it said.

Daewoong claims that it discovered the bacteria that produces the Type A botulinum toxin from soil taken from Korea. Medytox asserts Daewoong did not discover the bacteria from nature -- calling it a highly unlikely event from a scientific view -- but acquired it via dubious routes.

In the past, Daewoong did identify the source of its BTX bacteria in documents submitted to the Korea Centers for Disease Control and Prevention. However, the KCDC at the time did not conduct an epidemiological survey of the site where the bacteria been found, drawing criticism over the state’s lax management of the neurotoxin that can be fatal to humans.

Medytox stated that Daewoong “should not distort the essence of the lawsuit at hand” whose “core aim is to reveal whether or not Daewoong misappropriated Medytox’s BTX strain and manufacturing know-how.”

Medytox also reiterated that the firm’s founder brought the BTX strain to Korea for research purposes in February 1979, in accordance with local and international regulations at the time.

“Medytox will clarify any doubts about the company during a public discussion session attended by Daewoong, Korea’s regulatory officials, industry experts and the media,” it said.

“During this session, Daewoong should also reveal details about where and how it discovered the BTX bacteria for Nabota as well as present objective evidence including the full DNA sequence of its BTX strain to clear all doubts.”

A Medytox spokesperson said that the company plans to file a civil lawsuit against Daewoong on Thursday.

By Sohn Ji-young (jys@heraldcorp.com)