South Korea’s first botulinum toxin product Meditoxin has been stripped of its license, as of Thursday, in a blow dealt by the Drug Ministry against the company’s use of unauthorized substances in the botulinum toxin products manufactured between 2012 and 2015.
Meditoxin, the BTX product accountable for 42 percent of Medytox’s yearly revenue in 2019, had been suspended of production and sales since April 17. It will lose the sales permit altogether from June 25, the Drug Ministry said.
Medytox shares nose-dived 20 percent as of 2 p.m. on the day of the decision.
The unauthorized ingredient, while unspecified by either the Drug Ministry and Medytox, has yet to yield any side effects in the patients who had been administered the product.
The Drug Ministry deems that no harm is likely to come to patients treated with the wrinkle remover solution, but should any problems arise, there are compensation guidelines patients can follow. Side effects of BTX may occur in the process of administration, and not necessarily due to flaws in the product itself, in which case a medical disputes mediation system will review the details, according to the ministry.
While the distributed Meditoxin had shown no safety issues, the Drug Ministry found Medytox’s dishonesty condemnable.
According to authorities, Medytox tampered with papers to make it appear it was using authorized ingredients when they weren’t, manipulated the potency test to meet the standards in the cases they didn’t, applied for approval using doctored documents and commercially distributed such products.
In light of Medytox’s violation of the Pharmaceutical Affairs Act, all dosages of Meditoxin products are to be pulled from shelves for good.
Medytox is obligated to recall and dispose of all Meditoxin products.
As for the company’s innovative liquid-type BTX line, Innotox, the drug was levied a fine of 174.6 million won ($144,000) in place of what would otherwise have been a three-month suspension of manufacturing. The fine is according to Innotox’s 2019’s daily output multiplied by 90 days, the Drug Ministry explained.
“The Drug Ministry will show no tolerance to those who pose threat to the public health by deceiving the regulators,” wrote the ministry in its press release.
“Medytox’s document manipulations had been systematically covered up. It was insufficient to rely on administrative orders based on the Pharmaceutical Affairs Act, and the prosecutorial investigations had had to step in to uncover the misdeeds,” it added.
“A company who distributes unqualified product through document manipulation cannot be trusted. Its professional negligence not only affects the public health and welfare, it also poses negative impact on Korea’s overall pharmaceutical reputation.”
Medytox has to wait five years before the firm can make fresh applications. Before, the restraint was one year.
The company may apply for renewed sales approval for Meditoxin with proper documents in five years. In the meantime, Medytox would likely try to keep the business afloat with overseas exports, and with sales of its newer BTX lines Innotox and Coretox. The company also has a hyaluronic filler product on the market, alongside an aesthetic medical device. On the sidelines, it is conducting very early stages of cancer remedy research.
Apart from the gaping hole left by Meditoxin’s evaporation from the Korea market, Medytox also has the legal costs incurred from the fight against Daewoong Pharmaceutical to worry about. Medytox refrained from making remarks outside of its official notice to shareholders.
In a bid to prevent recurrence, the ministry said it will embolden the Good Manufacturing Practice data review and draw up a mechanism to track and monitor any and all data edits, erases and additions.
This will not affect the larger Korean BTX market, an industry insider offered.
“This is one company’s deviation from the norm. Medytox’s case will not reflect on the wider Korean BTX companies,” a BTX company employee opined under anonymity.
There are currently a number of Korean firms attempting to tap the aesthetic wrinkle treatment market in China.
Hugel is expected to make the first entry within mid-2020, followed by Daewoong Pharmaceutical.
By Lim Jeong-yeo (email@example.com)