MEDINET Japan and Stempeutics India (a group Company of Manipal Education & Medical Group) jointly announced that they have signed an option license agreement with rights to enter into an exclusive license agreement for Stempeucel product for the Japanese market for CLTI indication.
If exercised, the option would allow MEDINET to license exclusive rights to develop and commercialise Stempeucel product in Japan territory. Stempeutics received an upfront payment upon signing of the option license agreement and will receive license granted fees and additional milestones and royalty payments if MEDINET exercises the option to license Stempeucel®. Stempeucel product will be manufactured in the cGMP facility located at Bangalore and shipped to Japan for 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 that is caused by severe blockage in the arteries thereby reducing blood flow. This may result in the development of sores and wounds in legs and feet with a high risk of limb amputation. With the current contemporary vascular techniques, it is estimated only 25 per cent of patients can be managed with satisfactory clinical outcomes. Stempeucel is a breakthrough treatment which is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue.
Stempeucel is produced by pooling bone marrow-derived MSC’s (Mesenchymal Stromal Cells) of 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 strong immune-modulatory properties, broader cytokine / growth factors array, longer lifespan and consistent clinical outcomes.
Pooling underpins the clinical success demonstrated by Stempeucel. Stempeucel works thru’ anti-inflammatory & immuno-modulatory properties and by inducing angiogenesis in ischemic muscle – ultimately leading to improvement in the clinically relevant endpoints for CLI. Real World Evidence published by the practicing doctors reflects these improvements.
Commenting on this collaboration, Kanenao Kubushiro-san, 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-san, Executive Fellow, MEDINET and ISCT Regional Vice President Elect in Asia said, “Today is not only a great day for MEDINET & Stempeutics, but for everyone involved in the responsible development of stem cell therapies for urgent needs. Through MEDINET & 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 Ischemia Disease. We believe that Stem Cells will become a major branch of medical treatment and will become a standard of care for challenging diseases.”
It is a significant milestone for Stempeutics and a satisfying journey for Stempeutics, commented Dr. Pawan Kumar Gupta, President, Medical & Regulatory Affairs and ISCT Asia Regional Vice President. 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”.