Medytox told to destroy botulinum for exports

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Medytox told to destroy botulinum for exports

Medytox was ordered by the Korean regulator to destroy all its botulinum toxins made for export, after the products failed to meet quality standards.

The Ministry of Food and Drug Safety ordered Medytox on Wednesday to discard three product lines of its botulinum toxins made at the company’s factory in Osong, North Chungcheong, after results from the ministry’s August inspection showed that the toxins were not effective or safe enough.

Medytox’s botulinum toxin products for domestic use were found to meet quality standards. Medytox said it will follow the order from the Drug Safety Ministry and conduct additional investigations on its own.

Shares of Medytox fell 9.83 percent Thursday to 335,000 won ($284).

Investors were particularly sensitive to news about Medytox’s botulinum toxin, as the product is part of a dispute with Daewoong Pharmaceutical. Medytox has accused Daewoong of stealing its strain in manufacturing its own product, Nabota.

The U.S. International Trade Commission (ITC) has been investigating the case since Medytox filed a complaint against Daewoong earlier this year. The commission ordered both companies to do analyses of their products and file the results to the commission in July.

Medytox launched its botulinum toxin Medytoxin in 2006 while Daewoong launched Nabota later in 2014 and earned sales approval for the product from the U.S. Food and Drug Administration in 2017.

The Medytoxin manufacturer has been claiming that Daewoong stole its botulinum toxin strain since 2016 and took the matter to courts in Korea and the United States a year later.

Daewoong claimed earlier this month that it confirmed through its own tests that its botulinum toxin strain is different from that of Medytox. Medytox later disputed that.

Medytox submitted its report to the ITC last month while Daewoong submitted its report earlier this month.

The ITC is expected to decide on the case by next June. Regulations mandate that all procedures must be finalized within 15 months of a case being accepted by the ITC.

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