Kolon TissueGene to seek US FDA approval for new drug Invossa in 2021

Kolon TissueGene, the US-based biopharma unit of South Korea’s Kolon Group, said Tuesday that it will initiate phase 3 trials of its new osteoarthritis drug Invossa around September, with plans to submit a biologics license application to the US drug regulator by end-2021.

The firm is hoping to get the drug approved in the US as a “disease-modifying osteoarthritis drug,” or DMOAD, by proving through clinical trials that it not only alleviates pain and improves joint function, but also improves joint structure.

Joint structure improvement means proving the drug’s ability to slow down the progression of osteoarthritis or to regenerate joint tissue that was damaged, through statistically meaningful clinical data. 

“Our goal is to make Invossa a ‘game changer’ in the global osteoarthritis treatment market,” said Kolon TissueGene President and CEO Lee Woo-sok during a press conference held in Seoul.

Developed by Kolon TissueGene, Invossa is the world’s first cell-mediated gene therapy for treating osteoarthritis of the knee, in which the cartilage that cushions the joints wears away, causing the bones to rub together and induce pain.

A single injection of the drug delivers therapeutic relief for up to two years. The drug was approved in Korea in July last year for pain relief and function improvement, but not structural improvement including tissue regeneration. Patients diagnosed with K&L grade 3 osteoarthritis are eligible to use Invossa.

The upcoming phase 3 trials for Invossa in the US will involve 1,020 patients at 60 hospitals over the course of two years, with aims to gather up sufficient clinical evidence to obtain DMOAD designation, Lee said.

The world has yet to see a drug that has obtained DMOAD designation by any drug regulator in the world. Given this, there are mass opportunities for Invossa if it manages to obtain DMOAD status, he added.

Moreover, Kolon TissueGene will aim to expand Invossa’s potential patient group by working to get the osteoarthritis drug approved for patients with not only K&L grade 3 but also K&L grade 2 osteoarthritis. Grade 2 is a relatively less advanced form of the joint disease.

Looking ahead, Kolon TissueGene expects the global osteoarthritis treatment market to continue growing as aging patients grow in number, forging a favorable market for Invossa.

Citing figures quoted in a report from L.E.K. Consulting, Lee said the US osteoarthritis market is estimated at $5 billion. Since the US makes up around half of the global biologics market, the potential market for Invossa is as big as $10 billion, he said.

“In the future, we envision Invossa could become one the world’s 10 top-selling drugs in the world,” said the CEO. “We view Invossa as the only new drug from Korea that has actual potential to become a global blockbuster drug.”

The success of Invossa’s overseas trials are expected to determine the corporate value and share price of Kolon TissueGene and its parent companies in the future.

There is currently no viable treatment for osteoarthritis, only pain-relieving therapies, meaning a new drug with regenerative properties or the ability to significantly slow down or halt the disease’s progression, would be highly valued in the market. 

By Sohn Ji-young (jys@heraldcorp.com)