Stempeutics’ allogeneic cell therapy gets DCGI approval, Cipla to market and distribute Stempeucel

Cipla announced that its partner Stempeutics Research has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel in India. The product is indicated for the treatment of CLI due to Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease. It is the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment.

Under the agreement signed between the two companies, Cipla has received exclusive rights to market and distribute the product in India by leveraging its expansive distribution strengths across the country.

CLI is a progressive form of peripheral arterial disease that is caused by a severe blockage in the arteries, thereby reducing blood flow. This may result in the development of sores and wounds in legs and feet with a high risk of limb amputation. It is estimated that about five million patients in India are impacted by this debilitating disease. With the current contemporary vascular techniques, it is estimated only 25 per cent of patients can be managed with satisfactory clinical outcomes.

Stempeucel is a treatment which is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue. It is derived from allogeneic pooled mesenchymal stromal cells isolated from the bone marrow of healthy, adult voluntary donors. It directly addresses the root cause of the disease by reducing inflammation, stimulating the growth of collateral blood vessels and repairing damaged muscle, thereby reducing the pain, healing the ulcers and salvaging the affected limb. The drug is administered through intramuscular injections around the calf muscle region and around the site of ulcers.

Currently, Stempeutics is working on a strategy for other international markets including the US, EU and Japan. The global critical limb ischemia treatment market expected to generate $5,390 million by 2025, at a CAGR of 8.1% between 2020 and 2025.

Commenting on the DCGI approval, Manohar BN, MD & CEO of Stempeutics said, “Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics. We believe that the Stempeucel product is a game-changer, offering advanced therapeutic treatment for millions of patients suffering from this dreadful disease.”

Umang Vohra, MD and Global CEO of Cipla, said, “We are pleased to see that our decade-long partnership with Stempeutics has achieved a significant milestone. CLI is a serious and painful condition that impacts patients worldwide and we are happy that we are able to introduce this stem cell therapy in the country at an affordable cost.”

Dr Pawan Kumar Gupta, Senior VP, Medical & Regulatory Affairs, Stempeutics, said, “In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at immediate risk for limb amputation and death. Now Stempeucel provides hope for a new, effective treatment and a better quality of life for such CLI patients. Also, Stempeutics is committed to advancing its peripheral artery disease programs in CLI to other parts of the world.”