JUNIPER BIOLOGICS ACQUIRES CELL-MEDIATED GENE THERAPY TG-C LD FOR TREATMENT OF KNEE OSTEOARTHRITIS

$600 million USD acquisition will see Juniper Biologics offer the world's first cell-mediated gene therapy to an estimated 300 million patients in Asia Pacific, Middle East and Africa 

SINGAPORE, April 13, 2022 /PRNewswire/ -- Juniper Biologics, a science-led healthcare company focused on researching, developing and commercializing novel therapies announced today that it has gained the licensing rights to develop and commercialize TG-C LD (TissueGene-C low dose) for the treatment of knee osteoarthritis. 

The $600 million USD licensing deal which covers Asia Pacific, Middle East and Africa was signed with Kolon Life Science, and is Juniper Biologics' second acquisition in as many months. Under the terms of the partnership, Juniper Biologics will be responsible for developing and commercializing TG-C LD to medical professionals and hospitals within these regions. Kolon Life Science will be responsible for supporting the development as well as supplying TG-C LD.

TG-C LD is a non-surgical investigational treatment that has been hailed as the world's first cell-mediated gene therapy for osteoarthritis of the knee,^[i] which is the most common form of arthritis.^[ii] According to research, osteoarthritis is estimated to be the eleventh^[1] leading cause of disability worldwide with an estimated 300 million patients in Asia Pacific and Middle East and Africa alone, suffering from the debilitating effects of the degenerative joint disease. It is one of the biggest unmet medical needs among musculoskeletal conditions with the risk demonstrated to increase with age^[iii].

A first-in-class cell-mediated gene therapy, TG-C LD targets knee osteoarthritis through a single intra-articular injection. Kolon TissueGene, the license holder for TG-C in the United States (not TG-C LD), has already completed a phase 2 clinical trial in the United States, with initial data demonstrating sustained pain relief and mobility improvement following a single injection in the knee joint, for possibly up to 2 years. Phase 3 clinical trials in the United States comprising 1,020 patients are currently ongoing to confirm the safety and efficacy of TG-C. In addition to confirm the statistically significant pain reduction and function improvements observed from the US Phase 2 clinical trial, the trials are designed to show the delay of disease progression to achieve a DMOAD (Disease Modifying Osteoarthritis Drug) designation.

Juniper Biologics CEO, Raman Singh, said: "We are always looking to identify areas in which we can make the most difference and TG-C LD offers substantial relief for knee osteoarthritis patients who would otherwise be in need of surgery or other treatment options. We are committed to providing innovative treatments to treat osteoarthritis of the knee through the regeneration of cartilage and we believe this innovative investigational treatment will bring relief to millions of patients across the region."

"We are excited to work with Juniper Biologics to establish new avenues for patients to access this innovative investigational cell therapy. This would be a validation of our technology and its market value," said Woosok Lee President and CEO, Kolon Life Science. "We believe patients in Asia Pacific, Middle East and Africa will be able to benefit from TG-C LD as we go through the rigor of establishing it as a global standard treatment option."

About Juniper Biologics
Backed by The Sylvan Group, Juniper Biologics is a science-led healthcare company focused on delivering novel therapies to improve the health and quality of life of patients, by building a growing presence in Oncology, Rare/Orphan Diseases and Gene Therapy. It was founded on a vision to provide treatments for unmet medical needs focused on specialist therapy areas in which it can make the most difference. Through bold and transformative science, Juniper Biologics is committed to creating possibilities that have the potential to become the next generation of life-changing medicines for patient communities in China, Japan, Asia, Australia, New Zealand, Middle East and Africa.

About TG-C [TissueGene-C]  TG-C [TissueGene-C] is a first-in-class cell-mediated gene therapy targeting osteoarthritis (OA) of the knee through a single intra-articular injection. Clinical trials held in the United States and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic cell therapy product could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. The TG-C cell therapy product is being developed in two dosages: TG-C developed in the United States by Kolon TissueGene and TG-C LD developed in Korea by Kolon Life Science.

About Kolon Life Science

Kolon Life Science has been developing innovative cell and gene therapies since its founding in 2000. It has exclusive license of developing and commercializing TG-C LD in Asia, which has been granted by original developer of TG-C, Kolon TissueGene. Kolon Life Science's representative pipeline includes KLS-2031 which is targeting neuropathic pain and KLS-3021 which is oncolytic viral therapy. In addition to its biopharmaceuticals business, the company is also engaged in providing active pharmaceuticals ingredients (API), eco-chemicals including antimicrobials for personal-care and industrial applications, as well as water-treatment solutions. For more information, please visit www.kolonls.co.kr/eng.

For more information, please visit: www.JuniperBiologics.com