Stempeutics India and Novumcella Japan to work on development co-operation of Stempeucel product for Japanese market
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 commercializing Stempeucel® product for Buerger’s Disease
Stempeutics Research India and Novumcella Japan, jointly announced that they have signed an agreement for development co-operation of Stempeucel product for the Japanese market for Buerger’s Disease. Buerger’s Disease is an orphan indication in Japan. In 2017, Drugs Controller General (India) granted conditional approval for manufacturing & marketing of Stempeucel product for the treatment of Critical Limb Ischemia due to Buerger’s Disease. Now Stempeutics plans to commercialize Stempeucel product for the same indication in Japan in partnership with Novumcella.
Buerger’s Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterised 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’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization.
Commenting on this initiative, Yasuyuki Kusuhara, Founder & CEO of Novumcella said, “We are happy to partner with Stempeutics since its product Stempeucel is already 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”.
BN Manohar, CEO of 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.”
Dr Pawan Kumar Gupta, Senior VP, Medical and Regulatory Affairs of Stempeutics added “Stempeucel is an alternative method of treating CLI due to Buerger’s disease patients especially those unsuitable for revascularization and are suffering from a very poor quality of life. We completed preliminary consultation meeting with PMDA in 2019. Now along with Novumcella, we will be having formal discussion with PMDA in 2020 on Quality/CMC/Safety/Clinical aspects of Stempeucel product for getting necessary approval for conduct of pivotal bridge study for commercializing Stempeucel in Japan. Also Buerger’s being an Orphan indication, we are actively evaluating accelerated development of Stempeucel product in Japan with support from Novumcella”.