Mundipharma Signs Major Agreement with Kolon Life Sciences to Bring World's First Gene Therapy for Knee Osteoarthritis to Japan

Multi-year Invossa® deal signed for up to USD 600 million

Mundipharma will be responsible for the development,marketing and distribution of Invossa® to medical professionals and hospitals in Japan.

TOKYO,Nov. 19,2018 -- In a multi-year agreement for up to USD 600 million,Mundipharma has acquired the exclusive rights for Invossa® in Japan from Kolon Life Sciences.

Invossa® is a non-surgical treatment for osteoarthritis pain with long-term efficacy that has been hailed as the world's first cell-mediated gene therapy for osteoarthritis,[i] which is the most common form of arthritis.[ii]

A study in Japan found that in men and women aged over 40,the prevalence of knee osteoarthritis was 42.6% and 62.4% respectively,and that more than 31 million Japanese people could be affected.[iii] The risk of osteoarthritis increases with age[iv] and Japan has the oldest population in the world.[v]

This massive unmet patient need made it a priority for Mundipharma and Kolon Life Sciences to extend its partnership into Japan. The two entities first signed an agreement for Invossa® in Korea,where it was first approved by the Korean Ministry of Food and Drug Safety in 2017.

Mundipharma CEO,Raman Singh,said: "We are always looking to identify areas in which we can make the most difference. While we will go through the rigorous process of conducting clinical trials and getting Invossa® registered in Japan,it is very satisfying to think of the millions of patients who could benefit from this revolutionary medicine in the near future following this agreement."

"We are delighted to extend our partnership with Kolon Life Science. This 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 have access to new breakthrough treatments such as Invossa®," he added.

Invossa®is an intra-articular injection that is a non-surgical treatment option,which demonstrates sustained pain reduction and functional improvement of articular joint for one year following a single injection-- based on a US phase II clinical trial and a Korean phase III clinical trial.[vi],[vii]

Under the terms of the partnership,Mundipharma will be responsible for the development,marketing and distribution of Invossa® to medical professionals and hospitals in Japan.

"Mundipharma's global R&D,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® in Japan 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.

[i] http://kolonls.web31.youhost.co.kr/eng/02business/bio02.php

[ii] https://www.mayoclinic.org/diseases-conditions/osteoarthritis/symptoms-causes/syc-20351925

[iii] EpiCast Report: Osteoarthritis - Epidemiology Forecast to 2026

[iv] https://www.mayoclinic.org/diseases-conditions/osteoarthritis/symptoms-causes/syc-20351925

[v] https://www.worldatlas.com/articles/countries-with-the-largest-aging-population-in-the-world.html

[vi] Myung-Ku Kim,Chul-Won Ha,Yong In,Sung-Do Cho,Eui-Sung Choi,Jeong-Ku Ha,Ju-Hong Lee,Jae-Doo Yoo,Seong-Il Bin,Choong-Hyeok Choi,Hee-Soo Kyung,and Myung-Chul Lee.Human Gene Therapy Clinical Development. Mar 2018. Volume: 29 Issue 1: February 27,2018

[vii] Preliminary results of a phase II randomized study to determine the efficacy and safety of genetically engineered allogeneic human chondrocytes expressing TGF-b1 in patients with grade 3 chronic degenerative joint disease of the knee

About Invossa®

Invossa® is composed of a 3:1 mixture of normal human chondrocytes (hChonJ) and human chondrocytes transduced with the human TGF-B1 gene (hChonJb#7). The hChonJb#7 cells are irradiated prior to dosing to render them replication incompetent. Invossa® polarizes macrophage to M2 macrophage. M2 macrophage has an immune-regulatory function by producing Interleukin-10. Therefore,Invossa® 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® 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 visitwww.kolonls.co.kr/eng.

About Mundipharma

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

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