Kolon Life Science is working flat out to prove the safety of Invossa-K, the revoked gene therapy due to an ingredient mislabeling, in its legal fight against the government.
The company brought foreign experts as witnesses to the court and claimed that the ongoing prosecution’s probe revealed the treatment had no safety concerns.
The Seoul Administrative Court on Thursday held the second pleading for the case of Kolon Life Science against the Ministry of Food and Drug Safety to cancel the ministry’s decision to revoke the Invossa license.
The court reviewed the plaintiff Kolon’s plan to support its claim. The company requested the court to take three experts as witnesses. The three are Dr. Michael A. Mont, associate professor of Orthopedic Surgery Department at the Johns Hopkins University School of Medicine, Mahendra S. Rao, former director for the National Institutes of Health Intramural Center for Regenerative Medicine (NIH-CRM), and Lee Myung-chul, professor of the Orthopedic Surgery Department at Seoul National University Hospital.
The company also presented a plan to verify Invossa’s safety data by a third-party expert appointed by the court.
However, the defendant, the food and drug safety ministry, questioned the reliability of the witnesses requested by the plaintiff. The ministry said the three of them were deeply involved in Invossa development and clinical trials.
“Dr. Mont and Professor Lee participated in Invossa development or clinical studies in Korea and the U.S. We question their reliability,” the ministry said.
The court adopted Dr. Mont as the witness, saying that the process of Invossa development was a significant issue in the case. The court suspended the witness adoption of the other two.
The two sides also clashed over the Kolon’s third-party verification plan. Kolon said it would verify apoptosis assay by a third party to see if cells in the second fluid of Invossa are completely killed after irradiation. However, the ministry said radiation only stops self-replicating of the cells without killing them completely, which could raise concerns that the cells could be revived. Thus, a mere apoptosis assay within a lab cannot be evidence for the safety of the therapy, the ministry added.
The court said it would decide the verification plan after reviewing Kolon's detailed plan and the ministry’s opinion.
Kolon emphasized that Invossa was safe, mentioning the latest court’s refusal to issue an arrest warrant for a Kolon executive.
The prosecution began the investigation due to the safety concerns of Invossa. Still, only one out of four people that faced the prosecution's seeking of the arrest warrant was related to the safety issue, Kolon said.
The court’s rejection of arrest warrant for Kolon’s research head twice showed that the Invossa’s safety issue was irrelevant to a violation of the Pharmaceutical Affairs Act, Kolon claimed.
Also, on Thursday, the prosecution summoned Kolon Life Science CEO Lee Woo-sok as a suspect for the case, expanding the investigation to the management.
The prosecution has arrested three Kolon executives so far – Kolon Life Science director surnamed Cho (head of clinical development team), a division head surnamed Yang, and Kolon TissueGene’s chief financial officer surnamed Kwon.
Kolon Life Science's executive director surnamed Kim (head of the bioresearch center) avoided the arrest after the court refused to issue an arrest warrant for him twice. Cho is accused of submitting false data in the process of obtaining the Invossa license, and Yang and Kwon are suspected of fraud during the listing of Kolon TissueGene.