SINGAPORE, June 26, 2018 /PRNewswire/ — Mundipharma has announced the extension of its strategic partnership with Kolon Life Science to market Invossa®-K in Saudi Arabia and United Arab Emirates. Invossa®-K is a treatment for osteoarthritis pain with long-term efficacy. The agreement builds on the existing co-promotion agreement between the two companies in Korea signed in April 2017.
First approved by the Korean Ministry of Food and Drug Safety (MFDS) in 2017, the treatment has been hailed as the world’s first cell-mediated gene therapy for osteoarthritis.1 Invossa®-K is an intra-articular injection that is non-surgical treatment option, demonstrating sustained pain reduction and functional improvement of articular joint for two years following a single injection in a US phase II clinical trial and one year in a Korean phase III clinical trial.2,3
Under the terms of the partnership, Mundipharma will be responsible for the marketing and distribution of Invossa®-K to medical professionals and hospitals in Saudi Arabia and United Arab Emirates.
“We are delighted to extend our relationship with Kolon Life Science and Invossa®-K internationally,” said Raman Singh, CEO, Mundipharma. “This partnership is a prime example of how our partners can effectively leverage the strength of our network capability and experience to ensure that hospitals, GPs and patients in new markets like Saudi Arabia and United Arab Emirates have access to new breakthrough treatments like Invossa®-K,” he added.
The Osteoarthritis Research Society International (OARSI) defines osteoarthritis (OA) as ‘a disorder involving movable joints characterized by cell stress and extracellular matrix degradation initiated by micro- and macro-injury that activates maladaptive repair responses including pro-inflammatory pathways of innate immunity.’4
“Mundipharma’s global sales and marketing capability in the area of pain management makes it an ideal partner to establish successful pathways into new markets,” said Woo-Sok Lee, President and CEO, Kolon Life Sciences. “They are an ideal partner to help establish Invossa®-K in Saudi and UAE markets as we look to scale this breakthrough therapy as a global standard treatment option.”
®: INVOSSA is a Registered Trademark in Korea of Kolon TissueGene, Inc.
2 A multicenter Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients, Human Gene Therapy Clinical Development. 10. 1089/humc. 2017. 249
3 A phase II study to determine the efficacy and safety of allogeneic human chondrocytes expressing TGF-β1 in patients with grade 3 chronic degenerative joint disease of the knee. Protocol No. TGC09201. CSR. 2015 (data is not published yet)
4 OARSI. Definition of osteoarthritis. 2015 (cited 2015 18 November 2015).
Invossa®-K is composed of a 3:1 mixture of normal human chondrocytes (hChonJ) and human chondrocytes transduced with the human TGF-β1 gene (hChonJb#7). The hChonJb#7 cells are irradiated prior to dosing to render them replication incompetent. Invossa®-K polarizes macrophage to M2 macrophage. M2 macrophage has an immune-regulatory function by producing Interleukin-10. Therefore, Invossa®-K reduces pain and improves the articular immune environment to contribute to self-recovery of an articular joint.
About Kolon Life Science
Kolon Life Science has been developing innovative cell and gene therapies including Invossa®-K the world’s first cell-mediated gene therapy for osteoarthritis, since its founding in 2000. In addition to its biopharmaceuticals business, the company is also engaged in the business of 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.
Mundipharma’s independent associated companies are privately owned entities covering the world’s pharmaceutical markets. Mundipharma is a prime example of a company that consistently delivers high quality products while standing by the values that represent the company. Our mission is to alleviate the suffering of patients with cancer and non-cancer pain and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients with severe and debilitating diseases the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.
For more information please visit: www.mundipharma.com.sg