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MEDINET Japan, Stempeutics India ink deal for Stempeucel Cell Therapy for CLTI
License out/inCell TherapyDrug Approval
Bengaluru: MEDINET Co,Ltd, a Tokyo-listed
regenerativMEDINET Co,Ltd
and CDMO company, has signed an option license agreement with
StemCDMO companyarch Pvt. Ltd.
Stempeutics Research Pvt. Ltd. the development and commercialisation of the
StemManipal Group
Stempeucelin Japan for the treatment of
Chronic Limb Threatening Ischemia
The agreement grants MEDINET the right to enter into an exclusive license for
Stempeucel
Stempeucelanese market. Under the terms, Stempeutics will receive an upfront payment and, upon exercising the option, will be eligible for additional milestone payments, royalties, and licensing fees. The Stempeucel® product will be manufactured at Stempeutics’ cGMP facility in Bengaluru and exported to Japan for clinical trials and eventual commercialization.
Stempeucel is the first India-developedStempeuticsStempeucelStempeutics
product to be licensed by a Japanese firm and is patented in Japan. The product has received marketing approval from the Indian drug regulator (CDSCO) for treating
Critical Limb Ischemia
Critical Limb Ischemiar’s Disease and Atherosclerotic Peripheral Arterial Disease.
CLTI is a severeBuerger’s Diseaseal arAtherosclerotic Peripheral Arterial Diseaseod flow and a high risk of limb amputation. Stempeucel is designed to enhance the body’s natural ability to restore blood circulation through its anti-inflammatory, immunomodulatory, and pro-angiogenic properties.
Informing that signing a peripheral arterial diseaseJapanese Regenerative Medicine Company is an important and historic milesStempeuceltempeutics, BN Manohar, CEO, Stempeutics said, "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”.
Commenting on this collaboration, Kanenao Kubushiro-san, President and Representative Director of the Board, MEDINET said, “Our focus Stempeuticson is guided by ourStempeuticsse of responsibility to address unmet paStempeutics 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 StempeucelLTI 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."
MEDINET and Stempeutics have already held pre-consultation meetings with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to discuss regulatory pathways.StempeuticsStempeuticsStempeucel
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