MEDINET Japan and Stempeutics India, a group company of the Manipal Education & Medical Group, jointly announced that they have signed an option licence agreement with rights to enter into an exclusive licence agreement for the Stempeucel product for the Japanese market for CLTI indication.
If exercised, the option would allow MEDINET to license exclusive rights to develop and commercialise the Stempeucel product in the Japan territory. Stempeutics received an upfront payment upon signing of the option licence agreement and will receive licence granted fees, additional milestones, and royalty payments if MEDINET exercises the option to license Stempeucel.
Stempeucel will be manufactured in the cGMP facility located at Bengaluru and shipped to Japan for the conduct of clinical trials and for commercial use if exercised, based on the transfer price agreed between the parties.
CLTI is a progressive form of peripheral arterial disease caused by severe blockage in the arteries that reduces blood flow. This may result in sores and wounds in the legs and feet, with a high risk of limb amputation. With current contemporary vascular techniques, it is estimated that only 25 per cent of patients can be managed with satisfactory clinical outcomes. Stempeucel is designed to enhance the body’s limited capability to restore blood flow in ischaemic tissue.
Stempeucel is produced by pooling bone marrow-derived MSCs (Mesenchymal Stromal Cells) from healthy individuals through a proprietary, patented process. Research conducted at Stempeutics has shown that pooling balances out variations observed with individual donor cells, resulting in a product with immune-modulatory properties, a broader cytokine and growth factors array, longer lifespan, and consistent clinical outcomes. Pooling underpins the clinical success demonstrated by Stempeucel.
Stempeucel functions through anti-inflammatory and immuno-modulatory properties and by inducing angiogenesis in ischaemic muscle, leading to improvement in clinically relevant endpoints for CLI. Real World Evidence published by practising doctors reflects these improvements.
Kanenao Kubushiro, President and Representative Director of the Board, MEDINET, said, “Our focus on innovation is guided by our strong sense of responsibility to address unmet patient needs in Japan and alleviate suffering. We are happy to partner with Stempeutics since its product Stempeucel has already been approved in India and treated more than 600 CLTI patients. Also, the product has been patented in Japan. Data from Indian clinical trials will be useful for getting pivotal study approval in Japan. CLTI is a serious and painful condition that impacts patients in Japan, and we are happy that we will be able to introduce this therapy in the country in the near future.”
BN Manohar, CEO of Stempeutics, said, “Signing a licensing agreement with a Japanese Regenerative Medicine Company is an important and historic milestone for Stempeutics. It is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores our global leadership in allogeneic, pooled MSC technology. We believe that the Stempeucel product is a game-changer, offering an advanced therapeutic treatment for millions of patients suffering from this dreadful disease.”
Kunihiko Suzuki, Executive Fellow, MEDINET and ISCT Regional Vice President Elect in Asia, said, “Today is not only a great day for MEDINET and Stempeutics, but for everyone involved in the responsible development of stem cell therapies for urgent needs. Through MEDINET and Stempeutics collaboration, we will be bringing the next generation of biologics to address unmet medical needs. Physicians will have off-the-shelf stem cell therapy in their hands to fight Chronic Limb Threatening Ischaemia Disease. We believe that Stem Cells will become a major branch of medical treatment and will become a standard of care for challenging diseases.”
Dr Pawan Kumar Gupta, President, Medical & Regulatory Affairs and ISCT Asia Regional Vice President, said, “It is a significant milestone for Stempeutics and a satisfying journey for Stempeutics. Patients with CLTI are at an immediate risk for limb amputation and death. Now Stempeucel provides hope for a new, effective treatment and a better quality of life for such CLTI patients.”