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Medytox Public Announcement
The following is Medytox's statement concerning “the action by the Ministry of Food and Drug Safety (MFDS) regarding the orders including but not limited to the recall and disposal for Meditoxin products, etc. that were sold without obtaining national lot release approvals” Initially, we take a moment to sincerely apologize to all our customers and shareholders for the concerns that were caused due to this administrative action by the MFDS.The products that are the basis for this action by the MFDS were produced for exports, but the MFDS decided to cancel the license of such products after deciding that they are products for domestic sales. However, it is clear that drugs that are produced for exports are not subject to the MFDS’ national lot release approval under the Pharmaceutical Affairs Act.According to the Supreme Court's decision, drugs produced for exports, unlike those drugs for domestic sales, are not subject to the Pharmaceutical Affairs Act. Also, the Ministry of Health and Welfare of South Korea has previously made an authoritative interpretation that drugs for exports are not subject to the Pharmaceutical Affairs Act, and the MFDS has also expressed its opinion that drugs for exports which are not for domestic sales are not subject to the Pharmaceutical Affairs Act.In fact, the majority of Korean companies that manufacture and sell botulinum toxin products are selling drugs for export without the national lot release approvals process.Based on the above, it is clear that this MFDS action applying the Pharmaceutical Affairs Act to the drugs Medytox produced for exports is legally wrong. Accordingly, Medytox will immediately take legal actions to cancel this administrative action and apply for an injunction to suspend such action.It should be noted that previously the court ruled in favor of Medytox and decided to revoke the MFDS action that ordered the suspension of the production and sale of Meditoxin products and the cancellation of the products license.
2020.10.22
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The U.S. ITC Commissioners, ‘Decided to review certain portions of the initial determination from some of Daewoong’s objections’…’the review is merely a routine and regular practice’
The U.S. International Trade Commission (ITC) Commissioners, ‘Decided to review certain portions of the initial determination from some of Daewoong’s objections’…’the review is merely a routine and regular practice’ - The ITC Commissioners’ decision to review the initial determination (ID), ‘It is merely a routine and regular procedure,’ ‘There are rarely any occurrences where the ID is overturned by such review.’ -Medytox’s official stated that “the ID’s findings were based on scientific facts and evidence. We remain confident that the ITC will uphold the ID’s findings in the final determination on November.” Bio pharmaceutical company, Medytox (CEO Hyun Ho Jung) stated on the 22nd (U.S. time) that the U.S. ITC in Washington, D.C. “decided to review certain portions of the challenged parts by Daewoong in the ID, which earlier confirmed the Daewoong’s misappropriation, as a routine practice.” If even one member of the ITC Commissioners, which consists of five members, decides to accept a party’s objection, it is a routine and regular procedure to conduct review. The ITC investigation was instituted on February 2019 based on a complaint filed by Medytox and Allergan (now part of Abbvie) against Daewoong Pharmaceutical and Evolus. Through more than a year of extensive discovery, submission of expert evidence, and a five day evidentiary hearing, the ITC administrative law judge found this July that Daewoong misappropriated Medytox’s strain and trade secrets, ruling the ban on the import of Nabota into the U.S. for 10 years. Going forward, the ITC Commission will review legal remedies against Daewoong and Evolus in violation of section 337 of the Tariff Act along with reviewing certain portions of the challenged parts of the ID. Specifically, the Commission will review the judge’s recommendation that Nabota and Jeuveau be excluded from the US market for 10 years, the amount of bond to be posted for importation and sale of Nabota and Jeuveau during the period of time when the ITC’s remedial order is subject to final review by the President of the United States, and whether there is a compelling U.S. public interest that should outweigh the need for the remedial order. The ITC will render its final decision on November 6 (U.S. time), and, after two months when the decision is approved by the President, the decision will be finally confirmed.A Medytox official stated that "the ITC's review of some parts of the ID is just a routine and regular practice that generally occurs during the ITC investigations, and such review rarely changes the outcome of the ID" and "we are confident that the ITC will ultimately adopt the ID, as the judge made the right decision based on the scientific facts and evidence."A Medytox official further stated, "setting aside Korean toxin companies, not even the four companies that successfully commercialized the botulinum toxin type A strain worldwide have directly discovered the botulinum strain" and added "in the current situation where as many as twenty Korean companies claim to have discovered botulinum strains themselves, Medytox will not submit to any pressure or coercion and will continue to make efforts to reveal the truth in order to play a role in establishing a Korean bio industry where only companies that properly and legitimately develop their own technology will prosper.”
2020.09.28
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