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Mundipharma Announces Strategic Partnership with Kolon Life Science to Market Invossa(TM) in Korea

Hailed as world's first cell-medicated gene therapy for osteoarthritis
Strategic marketing partnership to ensure reach to surgeons, hospitals and GPs
Korean market partnership as a potential forerunner for global marketing expansion
2017-04-11 09:09 3031

SINGAPORE, April 11, 2017 /PRNewswire/ -- Mundipharma has announced a strategic partnership with Kolon Life Science to market InvossaTM, which has been hailed as the world's first cell-medicated gene therapy for osteoarthritis1, expected to be approved by the Korean Ministry of Food and Drug Safety (MFDS), in the second quarter of 2017.

InvossaTM 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 clinical trials2,3.

Under the terms of the partnership, Mundipharma will be responsible for the marketing and distribution of InvossaTM to general and semi-private hospitals, while Kolon Pharma will take responsibility for the general practitioner market. InvossaTM is exported globally by Mitsubishi Tanabe.

"Mundipharma is attracted to strategic partnerships that extend our ability to respond to patient needs in specific markets as well as improving treatment outcomes globally," said Raman Singh, CEO, Mundipharma. "This partnership levers the strength of our network capability and experience to ensure that hospitals, GPs and patients are informed and supported in the introduction of this new breakthrough treatment of osteoarthritic pain in Korea and beyond."

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 immunity4'.

Korea has an estimated five million patients requiring access to orthopaedic treatments every year, says Woo-Sok Lee President and CEO, Kolon Life Sciences. "Mundipharma is well-respected in the orthopaedic and neurosurgical community and has proven sales and marketing capabilities in the area of pain management and advanced wound dressing products in markets worldwide."

"They are an ideal partner to help establish InvossaTM in Korea and worldwide as we look to scale InvossaTM as a global standard treatment option."

1

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

2

A placebo controlled, double-blind, randomized, parallel-group, multi-center phase III study to determine the efficacy and safety of tissue-gene C in patients with degenerative osteoarthritis, Protocol No. KS-TGC-01-3. CSR v1.0. 2016 (data is not published yet)

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). http://oarsi.org/research/standardization-osteoarthritis-definitions

About InvossaTM

InvossaTM 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. InvossaTM polarize macrophage to M2 macrophage. M2 macrophage has immune-regulatory function by producing Interleukin-10. Therefore, InvossaTM reduce pain and improve articular immune environment contribute to self-recovery of 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 visit www.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 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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Source: Mundipharma
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