Meditoxin license revocation hearing postponed

The Drug Ministry hearing that could potentially revoke the pharmaceutical license for Meditoxin, South Korea’s first botulinum toxin product, was postponed on the day it was scheduled to be held, Monday.

The hearing is the pharmaceutical firm’s last chance to express its side of the story before the Drug Ministry makes a decision as to whether to withdraw its approval to manufacture and sell the drug.

It would have been a fateful day for Medytox, had it not been for a personal medical emergency affecting an official from the Drug Ministry. No new date has been set for the hearing.

“We are sure the hearing itself will take place, although right now it does seem like we are on a roller coaster ride,” a Medytox official told The Korea Herald.

Meditoxin is a clostridium botulinum toxin type A refined to treat several indications that not only include wrinkle smoothing, but also eyelid twitching and local muscle rigidity in the upper body. Upon launching in 2006 as the first Korean BTX product, Meditoxin sold over 16.9 million vials in the 13 years that followed, according to Medytox.

In 2019, Medytox reported 205.9 billion won ($167.7 million) in total revenue, of which Meditoxin accounted for 86.7 billion won, or 42.1 percent.

Due to the significant percentage of Meditoxin in its financial report, Medytox has been battling headwinds since April 17 -- after the Drug Ministry ordered to suspend manufacturing and sales of Meditoxin until further notice.

Medytox is being accused of using unauthorized ingredients in Meditoxin products made between December 2012 and June 2015. CEO Jung Hyun-ho and the chief of Medytox’s manufacturing facility in Cheongju, North Chungcheong Province, have been booked for alleged violations of the Pharmaceutical Act.

The company maintains that Meditoxin never caused any serious public harm. When asked about the alleged unauthorized material used in Meditoxin, it declined to disclose any information to The Korea Herald, citing the sensitivity of the ongoing legal matters.

Medytox had appealed to the Cheongju District Court to call off the Drug Ministry’s temporary sales ban, but was turned down Wednesday.

Should the final verdict from the court be unfavorable to Medytox, the company will not be able to apply for reauthorization of the identical product for at least a year or two, Kim Sang-bong, director of the Pharmaceutical Policy Division at the Ministry of Food and Drug Safety, told The Korea Herald.

As for Meditoxin’s business abroad -- where the product is variably called Neuronox, Siax, Botulift, Cunox and Acebloc -- Kim said, “We are always alerting other nations’ drug authorities of the pharmaceutical issues they should be aware of.”

The Drug Ministry’s final decision is estimated to take about two weeks from the hearing, based on the precedent of Kolon Life Science’s osteoarthritis gene therapy drug Invossa, which, in a similar slip, mislabeled a key ingredient and had its domestic license revoked 15 days after the hearing. Kolon Life Science has stayed afloat overseas, having won the green light to carry out phase 3 clinical trials of Invossa in the US through its US arm, Kolon TissueGene, even after the pharmaceutical license was withdrawn in Korea.

Likewise, the current rough patch may not spell the end of Medytox. Medytox’s attempts to attain the Chinese authority’s market approval is in murky waters, but also has not been entirely ruled out. It is unclear whether the Korean license revocation would effectively cut Meditoxin out of China. Meditoxin has completed phase 3 clinical trials in the country and is awaiting sales approval.

Currently in Korea, to make up for the loss incurred from the temporary sales ban, the company is giving a discount of 70 to 80 percent on its liquid-type BTX product Innotox and immune response risk-reduced product Coretox.

Should Meditoxin have its license stripped, Medytox is likely to face a lawsuit from shareholders, as well as having to shoulder the financial burden of recalled products.

Meanwhile, Medytox shares opened 4.41 percent lower at 110,500 won on Monday compared with the previous business day, and inched up to close 3.81 percent lower at 111,200 won.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)