Stempeutics Research, part of Manipal Education and Medical Group and a joint venture with Cipla Group, recently announced that it has been granted a process patent from the Japan Patent Office (application no. 2012-540529) for its stem cell-based drug Stempeucel®.
Stempeutics Research is the first company in the world to be granted a Japanese process patent for a stem cell-based drug based on novel pooling technology. The novelty includes the preparing and working master cell banks and the final therapeutic product. Stempeucel® uses allogenic pooled mesenchymal stromal cells from the bone marrow of healthy, adult donors.
The company’s pooling approach enables a more efficient manufacturing process, resulting in a more affordable product. Another benefit unique to this approach is that upwards of one million patient doses can be derived from a single set of master cell banks.
B N Manohar (Stempeutics Research Pvt Ltd, India) commented on the patent, “The new patent strengthens our position in Japan, which has created an accelerated development path for stem cell therapies. 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 are actively evaluating the potential for accelerated development of the Stempeucel product for critical limb ischemia (CLI) and osteoarthritis indications in Japan with strategic collaborations.”
While the proprietary technology allows the drug to be of therapeutic benefit across multiple disease categories, Stempeucel will initially be used for the treatment of CLI. Until now, drugs have typically treated the symptoms of CLI and the disease commonly results in amputation. This breakthrough treatment will tackle the cause of the disease.
Chandru Chawla (Cipla New Ventures, India) concluded, “Japan is showing great leadership in innovating a regulatory framework for regenerative medicine thereby addressing major unmet medical needs faster. We would like to leverage this new framework for rapid development of our Stempeucel product for the benefit of patients along with a potential partner.”
— Written by Daphne Boulicault