Cipla Limited announced that its partner Stempeutics Research Pvt. Ltd 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 ICE due to Buerger’s disease and atherosclerotic peripheral arterial disease. It is the first allogeneic cell therapy to be approved for commercial use in India and the first stem cell product to be approved globally for the treatment of CLI.
The product has been developed by Stempeutics over a period of 12 years. The company’s proprietary bundling approach offers an efficient manufacturing process that makes the product accessible to patients at an affordable cost. More than a million doses can be produced from a single set of cell banks, which is unique in regenerative medicine, offering consistent products to patients. The patented technology also helps Stempeucel expand the drug’s therapeutic potential in various disease categories.
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 forces in the country.
ICE is a progressive form of peripheral arterial disease that is caused by severe blockage in the arteries, reducing blood flow. This can result in the development of sores and wounds on the legs and feet with a high risk of limb amputation. It is estimated that around five million patients in India are affected by this debilitating disease. With current contemporary vascular techniques, it is estimated that only 25% of patients can be treated with satisfactory clinical results.
Stempeucel is a revolutionary treatment that is designed to enhance the body’s limited ability to restore blood flow to ischemic tissue. It is derived from mesenchymal stromal cells from the bone marrow of healthy adult volunteer donors. It directly addresses the root cause of the disease by reducing inflammation, stimulating the growth of collateral blood vessels, and repairing damaged muscle, reducing pain, healing ulcers, and protecting affected limbs. The drug is administered by intramuscular injections into the calf muscle region and around the site of the ulcers.
Stempeutics is currently working on a strategy for other international markets, including the US, the EU and Japan. The global market for critical limb ischemia treatment is estimated to generate $ 5.39 billion by 2025, at a CAGR of 8.1% between 2020 and 2025.
Regarding the approval of the DCGI, Manohar BN, President and CEO of Stempeutics, said: “Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics. It is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores our global leadership in allogeneic combined MSC technology. We believe that the Stempeucel® product will mark a change, offering advanced therapeutic treatment for millions of patients suffering from this terrible disease. “
Umang Vohra , Cipla’s Managing Director and Global CEO, said: “Our focus on innovation is guided by our strong sense of responsibility to address unmet needs of patients and alleviate suffering. We are delighted to see our partnership to Throughout the decade with Stempeutics he has achieved an important milestone. ICF is a serious and painful condition that affects patients around the world and we are delighted to be able to introduce this stem cell therapy in the country at a contained cost. “
Dr Pawan Kumar Gupta, Senior Vice President Medical and Regulatory Affairs, Stempeutics , said: “We are delighted to receive this marketing approval from DCGI for this important indication. At ICE, fatty deposits block arteries in the leg, leading to reduced blood flow, pain at rest, non-healing ulcers and gangrene. Patients with CLI are at immediate risk of limb amputation and death. Now, Stempeucel® offers hope for an effective new treatment and an improved quality of life for patients with ICE. In addition, Stempeutics is committed to advancing its peripheral arterial disease programs in ICE to other parts of the world.”
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