Kolon Life Science will separate its biologics drug manufacturing business to an independent entity tentatively called Kolon Biotech.
The separation is effective from Dec. 1, Kolon Life Science said through a shareholders’ notice on Friday.
Kolon Biotech will be responsible for contract manufacturing of biologics drugs, using a facility that has been freed up after Kolon Life Science ceased production of the controversially revoked gene therapy Invossa.
Kolon Life Science had battled an adverse business environment in Korea since the local drug authority decided to revoke the sales permit of Invossa.
Invossa was originally approved in 2017 by the Ministry of Food and Drug Safety for joint inflammation treatment, but was stripped of the license two years later in May 2019, after belated discovery that Kolon Life Science had mislabeled a key ingredient in its paperwork.
Patients who had been administered the Invossa injection are being tracked and monitored for any side effects.
Kolon Life Science claims Invossa’s safety and efficacy remain unscathed.
Since the license revocation in Korea, the US Food and Drug Administration has reviewed and still gave permission for Kolon Tissuegene to carry out clinical phase 3 trials of Invossa in the US. Kolon Tissuegene is Kolon Life Science’s US arm.
In Korea, Kolon Life Science will remain listed on the local bourse. The company said it does not plan to make Kolon Biotech public.
By Lim Jeong-yeo (firstname.lastname@example.org)