MEDINET & Stempeutics Pact for Stempeucel in Japan

New Delhi, Oct 29 (PTI) MEDINET Japan and Stempeutics India, part of Manipal Education & Medical Group, on Wednesday announced the signing of an option license for cell therapy product Stempeucel for chronic limb-threatening ischemia (CLTI) treatment for the Japanese market.

The agreement includes rights to enter into an exclusive license agreement for Stempeucel, and if exercised, the option would allow MEDINET to license exclusive rights to develop and commercialise Stempeucel product in the Japanese territory, the two firms said in a joint statement.

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, it said without disclosing the financial details.

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, the statement said.

Stempeucel is produced by pooling bone marrow-derived MSCs (Mesenchymal Stromal Cells) of healthy individuals through a proprietary, patented process, it added.

"We are happy to partner with Stempeutics since its product Stempeucel has already been approved in India and has 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," MEDINET President and Representative Director of the Board Kanenao Kubushiro said.

Stating that CLTI is a serious and painful condition that impacts patients in Japan, he said, "We are happy that we will be able to introduce this therapy in the country in the near future."

Stempeutics CEO BN Manohar said the signing of a licensing agreement with the Japanese regenerative medicine company is an important and historic milestone for Stempeutics.

"We believe that the Stempeucel product is a game-changer, offering an advanced therapeutic treatment for millions of patients suffering from this dreadful disease," he noted.

Stempeucel product will be manufactured 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, the statement said.