Medytox, South Korea’s largest marker of botulinum toxin in terms of market share, raised the suspicion that its rival Daewoong Pharmaceutical may have stolen the source of its anti-wrinkle fighting product and urged the company to disclose details of its BTX strain.

“Suspicion has grown that Daewoong stole the strain from us, as its genome sequence was found to be identical to Medytox’s,” the firm’s CEO Jung Hyun-ho said during a press conference Friday. 

His remarks come amid intensifying controversy over the origins of BTX. In early October, Medytox, which launched its BTX product for the first time in Korea, challenged second-tier firms Hugel and Daewoong Pharmaceutical to identify details of their BTX strain.

By analyzing a part of genome sequences of the strain Deawoong used to manufacture its wrinkle treatment, Medytox found they were identical to those used by the company.

Currently, Daewoong has registered some 12,900 genome sequences of its strain -- out of 3.7 million sequences -- to Genbank, a US nucleotide sequence and protein translation database where other global BTX makers such as Allergan have also released their data.

Medytox is demanding Daewoong identify its entire genome sequences to make sure that the strain was not stolen from its laboratory.

Jung said he has serious doubts about Daewoong as it has not revealed who discovered the strain or any research paper regarding the discovery.

“Except South Korea, there are only four companies in the world that commercialized drugs using botulinum toxin type A. But those Korean companies never gave details on the origins of their strains except Medytox,” Jung said.

While Medytox claims that its BTX bacteria came from a research lab at the University of Wisconsin-Madison, Daewoong asserts that its bacterium was extracted from soil in South Korea in 2006. 
 

Daewoong Pharmaceutical called Medytox’s claims “groundless” and “defamatory” in a statement to The Korea Herald.

“Medytox’s assertions that Daewoong stole the company’s BTX bacteria and could not possibly have discovered the bacteria in a natural setting, is groundless,” a Daewoong spokesperson said.

“We plan to push for legal action should Medytox continue to engage in slander,” he added.

Daewoong Pharmaceutical said it that it could eventually publicize the full genetic sequence of its botulinum toxin in the future, as pushed by Medytox, but not immediately.

Doing so would equate to blindly handing over critical data of its core product and technology to rival companies which would use the information to improve their own products, Daewoong said.

“In asking us to reveal our BTX product’s toxin gene sequence, Medytox wants to find out what factors differentiate our product from its own BTX which has been lagging in preparing for entry into the US market,” a Daewoong Pharmaceutical spokesperson said.

Daewoong has already concluded Phase 3 clinical trials of its BTX product in the US and plans to file the product for approval by the US Food and Drug Administration early next year.

Meanwhile, Medytox is preparing to initiate its Phase 3 clinical trials in the US by the first half of next year.

By Park Han-na and Sohn Ji-young (hnpark@heraldcorp.com) (jys@heraldcorp.com)