Stempeutics Research, a group company of Manipal Education and Medical Group and a joint venture with Cipla Group, has recently received process patent from the Japan Patent Office (application no 2012-540529) for its novel stem-cell based drug Stempeucel.
The novelty covers the method of preparing master cell banks, working cell banks and the final therapeutic product 'Stempeucel' based on the novel pooling technology.
Stempeucel will initially be used for the treatment of CLI, a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself. Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors.
The company proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients. This approach also allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine. The proprietary technology allows Stempeucel to extend the therapeutic potential of the drug across multiple disease categories.
Commenting on the Japan patent, B N Manohar, chief executive officer of Stempeutics, says “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 Stempeucel product for critical limb ischemia and osteoarthritis indications in Japan with strategic collaborations.”
Chandru Chawla, head of Cipla New Ventures, says “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.”