Stempeutics, Novumcella ink pact for development of stem cell drug Stempeucel in Japan

New Delhi: Biotech firm Stempeutics Research India and Japan-based Novumcella Inc on Monday said they have signed an agreement for development of stem cell drug, Stempeucel, for treatment of Buerger's Disease in the Japanese market. In 2017, the Drugs Controller General of India granted conditional approval for manufacturing and marketing of Stempeucel product for the treatment of Critical Limb Ischemia due to Buerger's Disease, it added.

The company now plans to commercialise Stempeucel for the same indication in Japan in partnership with Novumcella, the statement said.

As per the pact, 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, it added.

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 statement 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," Novumcella founder & CEO Yasuyuki Kusuhara said.

Data from Indian clinical trials will be useful for getting bridge study approval in Japan, he added.

"Moreover, Stempeutics has successfully completed Pre-IND meeting with the USFDA and scientific advisory meeting with the European Medicinal Agency for the Buerger's Disease. The feedback received from these regulatory agencies will support our Japan strategy," Kusuhara said.

In similar vein, Stempeutics CEO B N Manohar said, "Japan is showing a great leadership in innovating regulatory framework for regenerative medicine, thereby 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, he added.

"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," Manohar said.