The Thai government not only suspended the sale of Meditoxin, a botulinum toxin product by Medytox, but recalled all the Meditoxin products distributed in the market.
The recall is expected to take a heavy toll for Korea’s leading BTX maker, as Meditoxin sales in Thailand bring in 20 billion won ($16.2 million) annually.
|The FDA Thailand’s urgent notification to recall Medytox’s botulinum toxin Neuronox|
According to a document of the FDA Thailand obtained by Korea Biomedical Review, FDA Deputy Secretary-General Surachoke Tangwiwat sent an urgent notification to hospitals to recall all Neuronox (export name of Meditoxin) products on Monday.
The letter was titled “Notification for returning all registered Neuronox products distributed in the market.” The FDA Thailand said that it was “appropriate” to recall all series of Neuronox products from the market.
The recall came after the Korean Ministry of Food and Drug Safety informed the FDA Thailand that the Korean regulator temporarily suspended the sale of Meditox due to the company’s use of unauthorized substances and fabrication of data.
Earlier on May 14, the FDA Thailand suspended the sale of Neuronox apparently to prevent a similar problem in the Thai market. The Neuronox sales suspension was the first measure taken against the BTX product by a foreign government since the Korean ministry’s order to suspend Meditoxin sales.
The FDA Thailand moved further to order the recall of Neuronox, kicking out the BTX entirely out of the market.
The recall is expected to hit Medyotox’s earnings hard. Thailand is one of the major export markets for the Korean firm. The company earned 17 billion won or 12 percent of the total revenue from the Thai market between January and September last year. Medytox reportedly has over 60 percent share in the Thai BTX market.
Medytox recorded 86.7 billion won sales of Meditoxin, globally, and 45 billion won came from exports. By a simple calculation, half of Meditoxin exports come from Thailand.
“Thailand’s BTX market is worth about 50 billion won, which is the largest in Southeast Asia,” an official at a local pharmaceutical firm said. “If the product gets withdrawn from a major export market where it had over 50 percent market share, the recall will have a significant impact on the company.”
The government plans to nullify the license of Meditoxin, after finding that Medytox allegedly used unauthorized ingredients and faked test results to win approval for exports on scores of occasions between 2012 and 2015.
The food and drug safety ministry said it would hold a hearing on Friday and make the final decision.
Medytox CEO Jung Hyun-ho and the head of the company’s factory were indicted for trial. However, Medytox claimed that its BTX had no safety issue and that revoking the license is too harsh.
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