Medytox shares on Friday fell on news reports that the botulinum toxin maker was responsible for illegal administration of Meditoxin prior to gaining the Ministry of Food and Drug Safety’s approval.
Medytox shares finished Thursday at 415,000 won ($123), 1.96 percent down from a day earlier. At one point during the day the shares fell to 391,300 won, marking the lowest point in 52 weeks. The shares continued to vacillate undecidedly throughout Friday.
Medytox admitted it had administered Meditoxin to its employees in the early stage of development, before it was approved, but had strictly restricted access to regular patients. As for the other continued accusation of sterilization malpractice at plants, the company said it would duly comply with the authorities’ inspections and take responsibility.
Meditoxin, approved in March 2006, takes up about 40 percent of the domestic BTX market in Korea.
“As ours was the first attempt for a Korean firm to develop BTX, we needed conviction to go on,” a Medytox representative told The Korea Herald when asked why the company had given the unapproved treatment to staff.
Medytox had been a venture firm of some 50 employees in the cited period of 2003 to 2005 when the unapproved administrations took place.
“We obviously couldn’t administer between ourselves, so we took the vials to hospitals,” he said, adding that this was for “research purposes.”
He said that if Medytox had wished to make illicit profit it would make more sense to have traded thousands of vials.
Medytox reportedly used 114 vials at 10 hospitals. One vial contains enough toxin for four treatments.
MFDS said Friday that it was combing through the allegations raised about Medytoxin to confirm the product was produced under the latest safety management system.
“We regularly inspect the Medytox plant, and the Meditoxin qualities raised no alarms in 2014, 2016 and 2018 inspections,” the MFDS said.
Companies are alerted of the regular MFDS inspection in advance in written notifications according to the Act on Administrative Investigations, the MFDS said, adding that it will increase the number of unannounced inspections henceforth.
In response to accusations that the head of MFDS had held shares of Medytox when Meditoxin was approved, the MFDS said it will refer the case to an independent investigation agency to ensure fairness.
By Lim Jeong-yeo (firstname.lastname@example.org)