A Seoul court allowed Hugel to continue selling botulinum toxin Botulax temporarily, even though the Ministry of Food and Drug Safety earlier said it would order the company to suspend making and selling the product due to failure to obtain state approval for domestic sales.
With the quick court’s decision, industry watchers pay attention to whether Hugel will be able to restore investors’ trust.
Hugel said Thursday that the Seoul Administrative Court accepted the company’s request for cancellation and temporary suspension of the MFDS’ execution of the administrative order to suspend manufacturing and sales of Botulax.
Hugel requested on Thursday morning, and the court’s decision came later during the day.
It normally takes two to three days for a court to make a ruling on an injunction.
With the ruling, the MFDS’ punishment on Hugel will be suspended temporarily until Nov. 26.
On Wednesday, the MFDS said it would revoke the licenses of BTX products of Hugel and Pharma Research Bio and recall and discard the products because the companies did not get lot release certificates before selling them in the Korean market.
The MFDS said it would cancel the permits for Hugel’s four types of Botulax products – Botulax Inj. Botulax Inj. 50, Botulax Inj. 150, and Botulax Inj. 200.
Immediately after the MFDS’ announcement, Hugel filed an injunction with the court to stop the regulator’s administrative punishment.
Hugel argues that BTX products for exports are not subject to state authorization for local sales.
“The BTX products were made for exports, but the MFDS regarded them as those for local sales and took action,” Hugel said in a statement.
One day before the MFDS announced the administrative punishment plan, the Korea Exchange demanded Hugel explain whether rumors about the MFDS’ revocation of BTX license were true and suspended trading of Hugel shares on Wednesday.
Although Hugel stock trading was resumed on Thursday, the investor sentiment turned jittery.
Hugel’s stock price plummeted by 10.9 percent to close at 130,000 won ($110.1) on Thursday from 145,900 won on Tuesday.