Kolon Life Science’s osteoarthritis gene therapy drug’Invossa Kayju’ (Invossa) eventually failed to revive. The court decided that Invossa’s revocation of the item permission was legitimate. On the same day, the court pleaded not guilty to alleged manipulation of ingredients by company executives, but it became impossible for Invossa to be marketed in Korea.
![Kolon's osteoarthritis gene therapy drug'Invossa Kayju (Invossa)'. [사진 코오롱생명과학]](https://i0.wp.com/pds.joins.com/news/component/htmlphoto_mmdata/202102/19/47ac2887-9d18-44bb-a63e-169cfa8c703a.jpg?w=560&ssl=1)
Kolon’s osteoarthritis gene therapy drug’Invossa Kayju (Invossa)’. [사진 코오롱생명과학]
On the afternoon of the 19th, the 12th administrative division of the Seoul Administrative Court (Director Soon-wook Hong) ruled against the plaintiff in a lawsuit for cancellation of permission for manufacturing and sale items filed by Kolon Life Science against the Minister of Food and Drug Safety. It means that Invossa will remain in a state of being withdrawn from the domestic market.
“It was not intentional manipulation of the main ingredient, but it was worth canceling the permission.”
The court judged that there was no intentional manipulation of the ingredients of Invossa or in the approval process. The judge said, “There is insufficient evidence to admit that Kolon Life Sciences intentionally omitted and submitted the product approval to bring adverse consequences from the evidence submitted by the Ministry of Food and Drug Safety.” “According to the evidence submitted by the Ministry of Food and Drug Safety, it is inappropriate to view engineered Invossa 2 fluid cells (fetal kidney-derived cells) as drugs that lack stability.”
However, he said, “There is no problem with the cancellation of Invossa’s license,” he said, saying, “If it is revealed that other facts are stated in the product license, since drugs have a direct impact on life or health, there should be a serious defect in the disposition of the product license.” “Since it has been confirmed that the main ingredient of Invossa administered directly to the human body is not allogeneic cartilage-derived cells, but fetal kidney-derived cells, the KFDA can revoke the product permission ex officio. There is no illegality in the disposition.”
![Outline of false submission of'Invossa' [연합뉴스]](https://i0.wp.com/pds.joins.com/news/component/htmlphoto_mmdata/202102/19/8f89a15b-3417-4341-9c4d-761788fe6ee9.jpg?w=560&ssl=1)
Outline of false submission of’Invossa’ [연합뉴스]
Kolon executives are not guilty of manipulating… “Suspicious of insufficient verification by the Food and Drug Administration”
Invossa is Korea’s first osteoarthritis gene therapy developed by Kolon TissueGene and approved by Kolon Life Sciences from the Ministry of Food and Drug Safety. It consists of 1 solution containing human chondrocytes and 2 solution containing transformed cells introduced with chondrocyte growth factor. When two of these transformed cells were found to be kidney cells with tumor side effects, not cartilage-derived cells, in May 2019, the Ministry of Food and Drug Safety revoked the manufacturing and sales permission ex officio. Then, Kolon Life Science filed a lawsuit with the court asking for the cancellation of the disposition.
![Lee Woo-seok, CEO of Kolon Life Sciences, was involved in the suspicions surrounding Invossakeiju (Invossa). [뉴스1]](https://i0.wp.com/pds.joins.com/news/component/htmlphoto_mmdata/202102/19/76306b6c-c4b2-47a2-81e3-efcde02047cc.jpg?w=560&ssl=1)
Lee Woo-seok, CEO of Kolon Life Sciences, was involved in the suspicions surrounding Invossakeiju (Invossa). [뉴스1]
Separately, Kolon Life Science executives were tried on charges of intentionally manipulating ingredients. In February of last year, the prosecution prosecuted Lee Woo-seok, CEO of Kolon Life Sciences, and in July unequivocally prosecuted former Kolon Group chairman Lee Ung-ryul.
On the morning of that day, the Seoul Central District Court sentenced Jomo Kolon Life Science Medical Team Leader (Director) and Kim Mo Bio Research Institute (Executive Director) innocent to the charges of manipulating ingredients. The trials of former Chairman Lee Woong-ryul and Lee Woo-seok are expected to be affected.
Woo-Seok Lee, CEO of Kolon Life Sciences (above) and Woong-Ryeol Lee, former Chairman of Kolon Group (bottom), who attended each court for a substantive examination of an arrest warrant last year for manipulation of gene therapy’Invossa Kayju’ (Invossa). Of these, arrest warrants were issued only to CEO Lee Woo-seok. News 1
‘Color’ until the morning, the upper limit of 30% soared →’Gloomy’ in the afternoon
Mr. Cho and others were handed over to trial on charges such as hierarchical interference with the execution of public affairs, fraud under the Certain Economic Crimes Weighted Penalty Act, and violation of the Subsidy Management Act. The court admitted that Mr. Cho and Mr. Kim received approval for the item by writing the facts in the data, but pleaded innocence, saying, “I doubt whether the verification by the Ministry of Food and Drug Safety is insufficient in the process of product approval for Invossa.” In the process of developing Invossa, Mr. Cho was fined 5 million won after being admitted to bribing government officials of the Ministry of Food and Drug Safety of about 2 million won.
Until the morning, the news of Kolon Life Science’s executives’ innocence was announced, and there was a hopeful atmosphere about the cancellation of Invossa’s permission. Kolon Life Science’s KOSDAQ stock price also jumped at a 30% upper limit. But in the afternoon, when the exact opposite ruling came out against Invossa, Kolon Life Sciences couldn’t hide its embarrassment. The stock price, which had been the upper limit for several hours, also ended with an increase of 2.1% (450 won).
Hwawoo, the legal representative of Kolon’s side, said, “I will read the judgment carefully and reveal my position later.”
Reporter Dr. Ra [email protected]