An off-the-shelf option for knee osteoarthritis (OA) developed by biotechnology company Stempeutics will now be available to patients suffering from this debilitating disease. The allogeneic single-injection product, StemOne, will be marketed in India by drug-maker Alkem Laboratories.
There are different grades of knee OA and the single-injection option is recommended for those diagnosed as Grade 2 or 3, where there is still cartilage remaining in the joints, explains Manohar BN, Stempeutics Managing Director and Chief Executive. Advanced clinical trials on this regenerative product has shown that it prevents the condition from deteriorating, in that the cartilage is maintained and pain reduced, he said. Trials were done at 15 hospitals across the country in 146 patients over 65 years.
Alkem is pricing the product at ₹1.25 lakh (2ml vial), he told BusinessLine. But would that put the medicine beyond the reach of many? Manohar explains, the single-shot stem cell product prevents an individual’s condition from deteriorating, in the process averting a surgery (its cost and trauma). Besides, it is not a life-long therapy.
Break-through
The product is a break-through, because there are no “disease-modifying” medicines available, he said. Usually, patients are advised to follow non-pharma options including losing weight, then given pain medication, followed by inter-articular injections and steroids, he said. And if none of these work, they go in for a knee replacement surgery. About two lakh people in the country undergo surgeries, he said, estimated to be a ₹4,000 crore segment.
The stemcell product that can be used across genetically dissimilar patient profiles (allogeneic) is developed from the bone-marrow of healthy donors, he said, adding that three donors could support production of 90 lakh units. Armed with regulatory approvals to sell in India, Stempeutics is in discussion with the regulatory authority in the United States to undertake trials there, to eventually be able to sell there. About 19 million people in the US are estimated to suffer from the disease, he said. Stempeutics’ product pipeline includes a diabetes-oriented product and bio-cosmoceuticals.
Stempeutics is a group company of Manipal Education and Medical Group. Drugmaker Cipla and Kemwell (a biologics contract development and manufacturing organisation) are also stakeholders in the company. Cipla markets Stempeutics’ first product, Stempeucel, used to treat Critical Limb Ischemia due to Buerger’s disease, where blood supply to the lower extremities of the body is cut off.