 "Cipla's JV firm Stempeutics receives approval for stem cell drug in EU")
The Bengaluru-based Stempeutics Research, a group company of Manipal Education and Medical Group and a joint venture with Cipla Group, has announced that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product classification for its novel stem cell drug ‘Stempeucel’ which will be used for the treatment of Thromboangiitis Obliterans (TAO). The ATMP classification, approved by the committee for Advanced Therapies (CAT) of the European Medicines Agency, will allow Stempeutics to commercialise the product ‘Stempeucel’ across the European Union region.
Thromboangiitis Obliterans is a recurring progressive inflammation and thrombosis (clotting) of small and medium arteries and veins of the feet. It is strongly associated with use of tobacco products primarily from smoking, but also from smokeless tobacco. Stempeucel drug is expected to address the root cause of the disease through anti-inflammatory and immunemodulatory mechanisms. It is expected to induce angiogenesis through release of vascular endothelial growth factors, epithelial growth factors, angiopoietin and improve the perfusion and help the repair and regeneration of the ischemic muscle tissue.
The aim of the ATMP classification is to regulate cell and gene therapy and tissue engineered medicinal products, providing a benchmark for a level of quality compliance for pharmaceutical practices. The regulation provides guidelines to research development companies for following a standardised process in order to obtain approval in EU countries. The regulation also offers incentives to companies involved in developing ATMPs in the European Union, including fee reductions for scientific advice, scientific recommendations on ATMP classification and evaluation and certification of quality and non-clinical data.
Chandru Chawla, head - Cipla New Ventures, Cipla Limited, said, “We are extremely impressed by the incredible journey of innovations embarked by Stempeutics. Stempeucel will be a blessing for European patients who have been suffering with the rare disease – Thromboangiitis Obliterans. Cipla’s front-end presence in Europe will help in creating the right momentum for Access across Europe.”
Thromboangiitis Obliterans is a recurring progressive inflammation and thrombosis (clotting) of small and medium arteries and veins of the feet. It is strongly associated with use of tobacco products primarily from smoking, but also from smokeless tobacco. Stempeucel drug is expected to address the root cause of the disease through anti-inflammatory and immunemodulatory mechanisms. It is expected to induce angiogenesis through release of vascular endothelial growth factors, epithelial growth factors, angiopoietin and improve the perfusion and help the repair and regeneration of the ischemic muscle tissue.
The aim of the ATMP classification is to regulate cell and gene therapy and tissue engineered medicinal products, providing a benchmark for a level of quality compliance for pharmaceutical practices. The regulation provides guidelines to research development companies for following a standardised process in order to obtain approval in EU countries. The regulation also offers incentives to companies involved in developing ATMPs in the European Union, including fee reductions for scientific advice, scientific recommendations on ATMP classification and evaluation and certification of quality and non-clinical data.
Chandru Chawla, head - Cipla New Ventures, Cipla Limited, said, “We are extremely impressed by the incredible journey of innovations embarked by Stempeutics. Stempeucel will be a blessing for European patients who have been suffering with the rare disease – Thromboangiitis Obliterans. Cipla’s front-end presence in Europe will help in creating the right momentum for Access across Europe.”