The Ministry of Food and Drug Safety raided Medytox to investigate the alleged illegal sale of the company’s botulinum toxin (BTX) product. Industry watchers are paying attention to how the regulator’s probe will affect the company’s fate.
Pharmaceutical industry sources said the ministry’s central investigation team aided Medytox on Wednesday. The central investigation team collects and analyzes investigation information on food and drug hazards.
The investigation was reportedly about Medytox’s alleged overseas sale of its BTX product, a biological agent, without export approval.
In October last year, the ministry judged that Medytox violated the Pharmaceutical Affairs Act by selling Meditoxin and Coretox in China without the regulatory nod for shipping. The ministry ordered a recall-and-discard of certain product lines of Meditoxin and Coretox.
The ministry also began procedures for administrative penalties such as the suspension of the sale and revocation of the two products' licenses. In defiance, Medytox filed an administrative suit against the ministry and requested a court to suspend the ministry’s moves. The court accepted the company’s request, allowing Medytox to continue selling the two products until trials on the license nullification.
Also, the ministry discovered that Medytox used unauthorized raw materials to win the permit and revoked the licenses of Meditoxin and Coretox in June and that of Innotox in January.
However, the court’s recognition of Medytox’s request to stop the administrative penalty enabled the company to sell all of the three BTX products, the company said.
On the same day that the ministry raided Medytox, the company obtained approval for the sale of Coretox 100 units. The recent nod opened marketing opportunities for newly-produced goods in the domestic market, which signaled that Medytox’s business was returning to normalcy, the company said.
“With the start of the sale of the authorized product, we will recover our revenue in earnest,” an official at Medytox said.
In a civil lawsuit, Medytox is set to argue against Daewoong Pharmaceutical on March 17 over the BTX strain source.
Recently, Medytox and Allergan agreed that Daewoong’s U.S. partner firm Evolus could sell Daewoong’s BTX Nabota in the U.S., on the condition that Medytox and Allergan receive settlement money and royalties from Evolus. However, as Daewoong was not a party to the settlement, the local civil lawsuit between Medytox and Daewoong will continue.
The civil lawsuit is expected to draw more attention, as the two companies have submitted data collected during the suit with the U.S. International Trade Commission (ITC) last year.