Daewoong Pharmaceutical announced on the 27th that it has submitted a request to the US Food and Drug Administration (FDA) to investigate data manipulation of the liquid botulinum toxin formulation manufactured by Medytox. They also reported that they filed a complaint against Medytox to the Korean Financial Supervisory Service for violating disclosure obligations.
In January of this year, the Ministry of Food and Drug Safety was informed by the prosecution that Medytox had forged safety test data in the process of applying for product permission and change of the botulinum toxin drug’Innotox’, and canceled the product license.
Daewoong Pharmaceutical requested that Medytox confirm whether there was the same manipulation in the approval data submitted to the FDA based on the suspicion that the product that Medytox decided to export to the United States was the same product as Innotox.
In a request for investigation, Daewoong Pharmaceutical also urged the suspension of clinical trials of Medytox products in the United States.
Daewoong Pharmaceutical argued that “Meditox filed a lawsuit against Daewoong Pharmaceutical in the United States by claiming a patent on the botulinum toxin formulation, but the lawsuit itself is invalid as Innotox is based on false data.”
A Meditox official said, “The products that were exported to Allergan in the United States are quite different from Innotex, and this has already been revealed during the decision of the United States International Trade Commission (ITC).”
In addition, Daewoong Pharmaceutical has accused Medytox to the Financial Supervisory Service for violating disclosure obligations.
Daewoong Pharmaceutical said, “The prosecutor’s investigation and KFDA investigation results for illegal activities such as the use of unauthorized raw materials of Meditox, manipulation of test data, and the results of the investigation by the U.S. Aller were the same, and the contents involved in the smuggling of China. Etc. have not been clearly disclosed.”
Medytox and Daewoong Pharmaceutical have been fighting fiercely since 2016 over the source of the botulinum strain, the raw material of the botulinum toxin formulation. Medytox claims that the botulinum toxin drug’Nabota’, which Daewoong Pharmaceutical has developed in-house, is a product that stole its strain, and Daewoong Pharmaceutical has argued that it is a harassment of its competitors.
In February of this year, Medytox, partner Allergan, and Daewoong Pharmaceutical partner Evolus reached a three-party agreement, which seemed to end the conflict, but civil lawsuits at home and abroad are still continuing.
[yunhap news]
Author/ Translator: Jamie Kim
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