TissueGene, the U.S.-based biopharmaceutical firm held mostly by Korea’s Kolon Group, said it would tap the U.S. market in earnest by 2023 with its new cell gene therapy Invossa for osteoarthritis.

The statement came as the company plans to go public on the tech-heavy Kosdaq in November.

Lee Bum-sup, CEO and director of TissueGene, said Invossa has sufficient competitiveness to become successful in the U.S. market, at a news conference in Seoul Monday.

He added that about 70 percent of the company’s stake is held by Kolon Group and its subsidiaries such as Kolon Life Science and Kolon Glotech.

“Clinical trials have shown that Invossa not only reduced pain and improved joint functions but also drastically delayed the progress of the osteoarthritis and the timing of the surgery without drug-related side effects,” Lee told reporters.

“With a single injection, Invossa is an innovative therapy to improve the patient’s quality of life,” he went on to say.”

Founded in 1999, TissueGene became the first company in the world to develop a cell gene therapy to treat osteoarthritis, according to the firm. Kolon Life Science holds the sales right of Invossa in 22 Asian countries. The drug received a license from the Ministry of Food and Drug Safety on July 12.

Through two-year clinical trials in Korea and the U.S., Invossa proved its efficacy in pain reduction and joint function improvement, which are major elements of assessment. The company hopes to get a license in the U.S. by 2022.

In Korea, hospitals will start prescribing the drug next month, which will be manufactured from Kolon Life Science’s factory in Chungju, North Chungcheong Province. Observers said Invossa would be priced at about 4-5 million won ($3,530-$4,413) per vial.

TissueGene aims to have Invossa recognized as Disease Modifying Osteoarthritis Drug (DMOAD), and no drug for osteoarthritis has become DMOAD yet worldwide.

The company’s global advisory group members are also part of FNIH Osteoarthritis Biomarkers Consortium setting a new measure of osteoarthritis, which will help Invossa recognized as DMOAD, TissueGene said.

However, Invossa failed to prove efficacy on improving joint structures such as restoring damaged cartilage, which is an additional variable for assessment. The company attributed the failure to the small number of participating patients in the phase-3 clinical trial and the short time of 12 months. The firm said the efficacy on improving joint structures tends to show at least 12 months after the drug injection.

To overcome the issue, the company plans to recruit a larger number of patients in a phase-3 clinical trial in the U.S.

“In 70 sites in the U.S, we will conduct a two-year clinical test on 1,020 patients of Grades 2 or 3. Unlike in Korea, the U.S. recognizes both major and additional variables in assessment. So we anticipate that we could prove the drug’s efficacy in improving cartilage structure in the U.S.,” Lee said.

To make the U.S. clinical test successful, the company built partnerships with global contract manufacturing organizations (CMOs) such as Lonza, WuXi AppTech, BioReliance and Fisher Bioservice.

TissueGene also is preparing to expand the indications of Invossa from knee joints to hands, hip joints, rheumatism, meniscus and intervertebral discs.

“As the world’s first cell gene treatment for osteoarthritis, Invossa will become a blockbuster drug. In the global market, industry officials call it a ‘game-change drug.’ I’m sure we can prove its efficacy with enough data and standardized verification methods,” Lee said.

lhs@docdocdoc.co.kr

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