Kolon Life Science appeals to the Supreme Court for Invossa

Appeals to the Supreme Court against the license revocation ruling for its Invossa-K Inj

Will make efforts to restore scientific value and rectify the legal misunderstandings at the final trial

The appeal is unrelated to the outcome of the administrative proceedings and has no bearing on Kolon TissueGene's Phase III trial in the U.S.

"Will successfully complete trial and bring value."

On the 28th, Kolon Life Sciences decided to appeal to the Supreme Court against the manufacturing and sales license revocation ruling that had been made for its knee osteoarthritis cell gene therapy Invossa-K Inj (“Invossa”).

 

In its appeal to the court, Kolon Life Sciences explained, "While we respect the court's decision, we will strive to restore the scientific achievements and value of Invossa, the world's first gene therapy for osteoarthritis, by correcting the misunderstandings that arose regarding the product’s legal principles and safety at the appellate court.” In 2019, Kolon Life Sciences filed an administrative suit to seek the court’s ruling on the illegality and injustice of the MFDS’s decision to revoke Invossa’s marketing authorization but lost both the first and second trials.

 

Kolon Life Sciences acknowledged that there was an error in indicating the origin of the cells for the 2nd liquid, which was the main substance at the time of the application and approval of Invossa.

 

However, since all non-clinical and clinical trials were conducted with the same cells in all stages before its authorization, the company believes the safety and efficacy of Invossa have been verified by the MFDS, and based on which the company plans to continue its vigorous defense in the final appeals following the first and second appeals.

 

Kolon Life Sciences emphasized that the outcome of the administrative proceedings is completely unrelated to the Phase III clinical trial being conducted by Kolon TissueGene in the U.S.

 

and that it decided to proceed with the final trial to correct the misinformation related to Invossa and restore its scientific value.

 

Accordingly, regardless of the outcome of the administrative proceedings, Kolon TissueGene's Phase III clinical trial on TG-C (formerly known as Invossa) in the U.S.

 

is proceeding according to plan.

 

The company is enrolling and dosing 1,020 patients in the U.S., with the last 150 patients enrolled as of January 2024.

 

In addition, TG-C was approved by the U.S.

 

Food and Drug Administration (FDA) in December 2023 to expand its indication to Degenerative Disc Disease (DDD), in addition to being evaluated in Phase II clinical trials for knee osteoarthritis.

 

In October 2023, Kolon Life Sciences was acquitted on appeal in the second trial of a criminal case against company executives who were charged with obstruction of justice against the Ministry of Food and Drug Safety (MFDS), resolving allegations that the company engaged in intentional manipulation and concealment.

 

Long-term follow-up of patients from 2019 to the present has also shown no direct causal relationship between tumor development and treatment with Invossa.