Medytox to fight ministry's ban on Innotox in court
Medytox is set to initiate another legal battle against the Ministry of Food and Drug Safety, as the company announced Wednesday it will challenge a sales and production ban issued against its Innotox “Botox” product.
Late Tuesday, the Ministry of Food and Drug Safety ordered Medytox to halt sales and production of Innotox immediately. The company was accused of fabricating documents in the process of obtaining approvals.
The government body added it is commencing procedures to withdraw Innotox’s sales license, as the company “had obtained it through wrongful methods.” Notices were sent to hospitals and medical institutions ordering an immediate suspension to the use of the product.
This is the ministry’s third big blow this year to one of the country’s top three producers of botulinum toxin, a substance used to reduce wrinkles by paralyzing muscles. For the general public, it is best known as “Botox,” the brand name of the product made by Dublin-based Allergan.
The third order completes a grand slam which puts all three of Medytox’s botulinum toxin products — Medytoxin, Coretox and Innotox — at risks of sales suspension. Listed on Kosdaq, Medytox shares on Wednesday plummeted 7.91 percent.
The company was accused in April of using unapproved ingredients in Medytoxin and in October of failing to fulfill labeling and reporting requirements for botulinum toxin exports, including Coretox.
Medytox said Wednesday it plans to file a suit to fight the ministry’s order and obtain an injunction against the order until the challenge is heard in court. This is what it did for Medytoxin and Coretox earlier this year, and it has managed to continue sales and production for both so far.
“In regards to the Daejeon Ministry of Food and Drug Safety’s temporary sales and production ban on Innotox, we will file a suit to block execution and nullify the order,” it said in a statement uploaded on the company’s website.
Medytox is headquartered in Daejeon and is under the jurisdiction of the ministry’s office there.
“On cancelation of the sales license, the company will fully engage in administrative procedures to provide an explanation," it added.
According to Medytox’s regulatory filing, Innotox generated 8.5 billion won ($7.7 million) in sales last year, accounting for 4.7 of the company’s annual revenue.
Trouble for Innotox began when an anonymous whistleblower — a former Medytox employee, according to the company — reported that Medytox had violated domestic pharmaceutical law by submitting false data to obtain a sales permit.
Earlier this month, prosecutors indicted Medytox’s chief executive, saying it confirmed the company had fabricated safety test results. They believe there was an “obstruction of performance of official duties by fraudulent means,” meaning executives ordered employees to act in a way that interfered with the execution of public duty.
This year has been a tough one for the botulinum toxin manufacturer, which in 2006 was the first domestic company to obtain a government permit for botulinum toxin.
Last week, the company achieved a victory after a two-year legal battle at the U.S. International Trade Commission against Daewoong Pharmaceutical, which it accused of stealing botulinum toxin strains and production technology. But the two still have law suits ongoing in Korea and the United States over the same issue.
BY SONG KYOUNG-SON [email@example.com]
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