Kolon Life Science announced on April 1 that it has decided to suspend sales of its new osteoarthritis drug Invossa.
According to the company, the decision was made after the its US unit Kolon TissueGene found going through the advanced and recently developed examination method STR that a component in Invossa was labeled incorrectly. The Ministry of Food and Drug Safety also on March 31 requested it to suspend sales.
“We understand the disappointment, which comes from Innvosa’s high expectation as the first gene therapy candidate for treating osteoarthritis. We apologize to patients who need Innvosa for treatment and also people who work in the bio industry,” Kolon Life Science CEO Lee woo-suk said during a press conference.
The South Korean pharma firm spent more than 19 years to develop Inovassa, an intra-articular injection that is a nonsurgical treatment option to treat the knee disorder. The drug is comprised of mainly two parts -- 75 percent of the drug treats osteoarthritis and the remaining 25 percent of component works as a mediator that assists the main component and expires after around two weeks.
The recent problem was caused due to this component, which was labeled as “gene containing chondrocyte,” since 2004. The firm recently found that a kidney cell was included in the component and should have been labeled accordingly.
The company said additional examination of cells used in Korea is currently underway and the results are expected to come after two weeks. Based on the results, it hopes to discuss with the ministry about resuming sales.
Despite this chaotic situation, the firm added that it is still confident about Invossa’s effectiveness and its safety. “The substances that we used to make the drug are still the same. We have only been labeling it with a wrong name tag,” Yoo Soo-hyun, a director of the company’s bio sector said.
The company also noted that some of its plans to expand its presence overseas might be slightly delayed but will not have a huge impact. “As long as we prove to our overseas business partner Innvossa’s safety and effectiveness, they will still see business potential in our product,” Lee said.
Most recently, the company signed a deal worth 667.7 billion won ($591.60 million) with Mundipharma to license out Invossa for the Japanese market. It also signed a deal with partners in 20 different countries, including China, Australia and Hong Kong, to supply its products.
By Song Seung-hyun (firstname.lastname@example.org)