KLS shares closed at 52,700 won ($46) on this day, a 29.92 percent tumble from the previous day.
The report was authored by Kolon Group’s US biopharma unit Kolon TissueGene, which said that a Short Tandem Repeat analysis revealed the osteoarthritis treatment drug was made based on a cell different than that specified in paperwork for official approval when the research for the drug first began.
In an attempt to minimize the fallout, KLS held an emergency press conference explaining the background behind the error.
|Kolon Life Science officials at an emergency press conference Monday at the Korea Press Foundation. (Lim Jeong-yeo/The Korea Herald)|
“The safety and efficacy of Invossa remains unchanged,” said KLS CEO Lee Woo-suk at the Korea Press Foundation in central Seoul, adding that the company expects no drastic changes in business for the drug.
Due to “technical limitations” in the early 2000s, the researchers had not been able to properly identify the cell that became the basis for Invossa, Lee said. He claimed that it did not affect the validity of later clinical trials and successful patient cases, which were built on the master cell bank established using that cell.
KLS said that the transformed cell that it had used to generate transforming growth factor beta 1, or TGF-beta 1, for alleviation of joint pain had not come from the cartilage-originated cell chondrocyte, as its test at the time led it to believe, but rather, the kidney-originated 293 cell.
The company admitted it had taken them 15 years to realize the error in a more advanced STR analysis, commonly used for paternity confirmation. KLS emphasized the test had been carried out voluntarily in advanced preparation for its review with the US Food and Drug Administration.
CEO Lee said while he foresees delays in business plans, KLS is positive that a labeling change will be sufficient to re-establish the Korean Ministry of Food and Drug Safety’s approval of the drug.
Invossa is No. 29 on the chronological list of 30 Korea-made original drugs. Kolon Life Science gained domestic sales approval for the drug in July 2017 and began sales in November of the same year.
In 2018, the injectable drug had been administered to some 2,600 patients in Korea, for a cumulative number of 3,400.
A single Invossa injection can cost anywhere from 5 million won ($4,400) to 8 million won, depending on the hospital.
|Kolon Life Science officials at an emergency press conference held Monday at Korea Press Foundation. (Lim Jeong-yeo/The Korea Herald)|
Outside of Korea, Invossa is sold in Hong Kong and Macau.
In January, KLS inked an Invossa export deal with global pharmaceuticals company Mundipharma to ship products to seven Asian nations, including Singapore and Indonesia, once the companies gain local approval. The firm in July 2018 had also signed with Chinese medical service company China Life Medical Centre to provide Invossa in Hainan, China for five years.
KLS currently holds sales rights to Invossa in 22 Asian countries and has been pushing to license out Invossa to Taiwan, India, Bangladesh, Cambodia, Nepal, Pakistan, Sri Lanka, Brunei and Laos.
When asked if KLS had plans to compensate patients who could be upset to learn the changes in the drug specifications, CEO Lee said that KLS is certain of Invossa’s safety and efficacy. No side effects or negative reviews were submitted in the 10 years KLS has carried out clinical trials and actual sales. The company does not expect patients to take legal action.
There will be no inventory recall, as Invossa is sold via an on-demand production system, meaning every order directly leaves from KLS’ plant in Chungju, North Chungcheong Province.
By Lim Jeong-yeo (firstname.lastname@example.org)