Kolon TissueGene said in a public filing that it notified its parent company Kolon Life Science in March 2017 that the cell ingredient of the second fluid of Invossa-K was not cartilage-derived but kidney-derived cells (GP2-293 cells).
The public disclosure runs against Kolon Life Science’s allegation that it found the mislabeling through a short tandem repeat (STR) testing for the first time in late February this year. The disclosure sparked suspicion that Kolon might have been concealing the mislabeling for two years.
“We have confirmed that Kolon TissueGene received a test result from a manufacturing firm (Lonza) through an SRT testing that the second fluid contained 293 cells in March 2017, and produced the drugs after finding that there was no problem in manufacturing,” Kolon Life Science said on Friday.
In other words, two years before the mislabeling of the cell ingredient of the osteoarthritis injection became an issue, Lonza ran the STR test, confirmed the second ingredient was 293 cells and notified it to Kolon TissueGene.
The subsidiary’s revelation contradicts Kolon Life Science’s claim.
Kolon Life Science recently came to know that the cell ingredient has been mislabeled for 15 years because it had not conducted any STR testing since the analysis in 2004 when the company had to build the initial master cell bank.
However, the latest filing by Kolon TissueGene made its parent firm admit that Kolon had an STR testing on Invossa two years ago and knew that the second fluid’s cells were 293 cells.
Kolon obtained approval for Invossa from the Ministry of Food and Drug Safety in July 2017.
March 2017 was before the winning of the Invossa license. If the regulator had known that the cell ingredient was 293 cells, it might have suspended the drug review until additional data was ready, or even refused to grant the nod.
There is no authorized drug in the world that was approved for using 293 cells as an injection for treatment. If Kolon had known it, it has been covering it up.
Kolon Life Science said it was true that it received the result of the STR testing in 2017, but neither Kolon Life Science nor Kolon Tissuegene knew what 293 cells meant at that time.
“Lonza ran the STR test and notified the result that the ingredient was 293 cells in 2017. However, researchers at TissueGene did not know the meaning of 293 cells and focused only on the phrase that ‘there was no problem in manufacturing’ and did not report it to seniors,” an official at Kolon Life Science said.
“We (Kolon Life Science, Kolon TissueGene) later learned that we had received an STR test result in the past after Mitsubishi Tanabe Pharma added such information in a suit pursuing the return the upfront payment over the cancellation of the licensing deal for Invossa.”
However, it is entirely unconvincing that researchers at Kolon TissueGene did not understand what STR test results meant and report it to seniors, observers said. If it were true, it still had time to check on the past test materials after the regulator suspended the sales of Invossa in February, they said.
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