Bengaluru: Manipal Group’s stem cell company, Stempeutics Research India and Novumcella Inc. Japan, have
signed an agreement for development co-operation of stem cell based treatment for Buerger’s Disease in the Japanese market.
“Stempeucel is validated in multiple clinical trials in India for Buerger’s Disease and also the product has been patented in Japan. Data from Indian clinical trials will be useful for getting bridge study approval in Japan. Moreover Stempeutics has successfully completed PreIND meeting with US FDA and Scientific Advisory meeting with European Medicinal Agency for the Buerger’ Disease. The feedback received from these regulatory agencies will support our Japan strategy,” said Yasuyuki Kusuhara, Founder & CEO of Novumcella. Buerger’s Disease is an orphan indication in Japan.
Buerger’s Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation. Stempeucel treatment is designed to enhance the body and limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularisation.
In 2017, Drugs Controller General (India) granted conditional approval for manufacturing and marketing of Stempeucel product for the treatment of Critical Limb Ischemia due to Buerger’s Disease. Now Stempeutics plans to commercialise Stempeucel product for the same indication in Japan in partnership with Novumcella.
As per the agreement, Novumcella will initially provide regulatory support services to Stempeutics for getting approval from Pharmaceuticals and Medical Devices Agency, Japan (PMDA) for conduct of bridge study in Japan for commercialising Stempeucel product for Buerger’s Disease. Upon PMDA approval for conduct of bridging study, Novumcella will take care of the cost required for conduct of the bridge study in Japan based on commercial agreement, the company said. Stempeutics had preliminary consultation meeting with PMDA in 2019 towards commercialising Stempeucel product for Buerger’s disease.
BN Manohar, CEO, Stempeutics said, “Japan is showing a great leadership in innovating regulatory frame work for regenerative medicine there by addressing major unmet medical needs faster. The new regenerative medicine law implemented in Japan allows conditional approval of stem cell products thereby enabling more rapid entry into the Japanese market. We would like to leverage this new framework for rapid development of
Stempeucel product for the benefits of the patients in Japan in collaboration with Novumcella. Novumcella will support us in finding a suitable Japanese Pharma partner for marketing Stempeucel product in Japan.”