PharmaResearch Bio will be able to keep manufacturing and exporting its botulinum toxin product, ReNTOX, temporarily.

As the Seoul Administrative Court took the company’s side in its legal battle with the Ministry of Food and Drug Safety, market watchers are paying keen attention to how the ministry would respond to it.

In a public notice last Friday, PharmaResearch Bio said that the company received a decision from the court to suspend the execution of the ministry’s administrative order to nullify the permission of ReNTOX and suspend its production for six months.

According to the public notice, the Seoul Administrative Court said it would suspend the effect of an administrative order to cancel the permit for ReNTOX (100 and 200 units), stop their manufacturing for six months, recall and discard the existing products until 30 days after the final ruling of a lawsuit for revoking administrative disposition.

“According to data submitted by the petitioner (PharmaResearch Bio), each of the administrative dispositions could inflict damage on the petitioner, and there is an urgent to prevent the damage,” the court said. “On the other hand, it is difficult to think that the suspension of each disposition would exert significant influence on the public good or make it impossible to accept the claim on the merits.”

In response, PharmaResearch Bio said, “There will be no effects on the manufacturing and exporting of our products until 30 days after the date of the judgment of the cases on the merits. We are filing a lawsuit to cancel the administrative dispositions to make proper legal responses to them.”

In November, the ministry ordered the company to recall and discard ReNTOX products and stop manufacturing them provisionally. Later, the Seoul Regional Food and Drug Administration revoked their permits and suspended their manufacturing for six months.

According to the ministry's investigations, the company was suspected of marketing the botulinum toxin products, a biological therapy, at the domestic market without winning approval for national shipment.

Thanks to the administrative court’s citation of suspending the order’s validity, the company will be able to make and export ReNTOX products until its legal battle against the ministry starts in earnest.

However, the Seoul Regional Food and Drug Administration may likely file an appeal against the court’s ruling, market observers are watching with interest how the case will develop.