Stempeutics Research, a group company of Manipal Education & Medical Group and a joint venture with Cipla Group, announced that its Stempeucel drug for the treatment of thromboangiitis obliterans has received Orphan Drug Designation (ODD) from European Medicines Agency (EMA). Thromboangiitis obliterans or Buerger's disease is a rare and severe disease affecting the blood vessels of the legs.
It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation. Stempeucel treatment is designed to enhance the body's limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization.
Commenting on the ODD status, B N Manohar, chief executive officer of Stempeutics said, "Obtaining Orphan Designation for Stempeucel in the European Union (EU) is an important regulatory milestone for Stempeutics. The benefits include 10 years of market exclusivity from product launch in the EU, fee reductions, as well as access to the central authorization procedure. This orphan drug designation supports Stempeutics global development strategy for Stempeucel drug and the goal of providing improved therapies for patients with thromboangiitis obliterans”.
“We are pleased to have been granted the benefits of orphan drug designation in Europe," said Chandru Chawla, head of Cipla New Ventures. “We view this as an important milestone to further develop our novel stem cell biological drug Stempeucel in the EU for treating thromboangiitis obliterans indication. Additionally, we interpret this as a favourable indication for how the European regulators view our therapy. This significantly increases the commercial potential of our ground breaking therapy.”
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 immune-modulatory 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.