Kolon Life Science apologizes for Invossa mislabeling, but insists drug was safe

By Lim Jeong-yeo
  • Published : Jul 4, 2019 - 15:04
  • Updated : Jul 4, 2019 - 17:37

The chief of Kolon Life Science on Thursday reiterated the safety of the now-banned joint inflammation treatment Invossa, while apologizing for the market confusion and credibility depreciation.

“As top representative, I deeply apologize on behalf of the company for causing worries and confusion to patients, investors and the medical circles,” said KLS CEO Lee Woo-suk in a press conference held at the Korea Press Center in downtown Seoul.

The disputed mislabeling of the substance in Invossa was due to system flaws in the early days of bio development, he explained.

“Invossa was born in a small laboratory in the US 17 years ago as the world’s first gene therapy drug for joint inflammation,” Lee said.

Kolon Life Science’s CEO Lee Woo-suk apologizes to patients, investors and doctors, maintains the safety of Invossa and pledges to bring up company value, at a press event held Thursday at the Korea Press Foundation in Jung-gu, Seoul. (Lim Jeong-yeo/The Korea Herald)
Kolon Life Science CEO Lee Woo-suk (Lim Jeong-yeo/The Korea Herald)

“The cell identification technology, which had required our best efforts back then, fell short of the advanced technology level of today.”

Still, the drug as an end-product has been tested and proved of its safety and efficacy on patients, Lee stressed.

“This does not mean that our past shortcomings should be forgiven,” he said.

“But we continue to remain confident over the safety and effectiveness of Invossa.”

The company will continue to develop novel drugs and gene therapy pipelines, seeking to recover trust from investors, he added.

The Ministry of Food and Drug Safety on Wednesday finalized its decision to revoke the permit for Invossa. Meanwhile, prosecutors are currently conducting a probe to check the approval procedure of the drug.

As for the patients who have taken Invossa shots, the company will provide a 15-year follow-up medical checkup for all registered patients, in collaboration with 20 hospitals nationwide, according to Yoo Soo-Hyun, the managing director at KLS. Some 80 billion won ($68 million) has been allocated in the company’s business report for the purpose.
Kolon Life Science’s CEO Lee Woo-suk (right) and Managing Director Yoo Soo-hyun (Lim Jeong-yeo/The Korea Herald)

Having started to collect patient registration data in mid-April, the company has so far collected information from 1,725 patients and is expecting to gather 3,700 by October.

When asked whether the 15-year follow-up plan is a plot to use the test results to develop a new alternative drug, CEO Lee left the room without taking the question, citing ongoing legal procedures.

Following the press conference, OhKims Law & Co. which represents over 760 patients that have taken Invossa, expressed discomfort over the company’s investor-focused stance.

“All of Kolon’s narrative so far focuses on investors. CEO Lee’s claim of clearing uncertainty is about the company value and not patient anxiety,” the law firm said in a press release, “We urge KLS to resume accountability as a pharmaceutical firm whose foremost value is in treating patients.”

By Lim Jeong-yeo (