MEDINET Japan and Stempeutics India (a group Company of Manipal Education & Medical Group) have signed an option license agreement with rights to enter into an exclusive license agreement for Stempeucel® product for the Japanese market for Chronic Limb Threatening Ischemia (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, India 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% 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®.
