 "Stempeutics receives EU orphan drug designation for novel stem cell drug")
The European Medicines Agency (EMA) has granted orphan drug designation (ODD) for Stempeutics Research’s novel stem cell drug Stempeucel used in the treatment of thromboangiitis obliterans. The Bangalore-based Stempeutics Research is a group company of Manipal Education & Medical Group and a joint venture with Cipla Group.
Commenting on the ODD status, B N Manohar, CEO 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 authorisation 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.”
Thromboangiitis obliterans or Buerger's Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterised 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 neovascularisation.
Chandru Chawla, head of Cipla New Ventures, added, “We are pleased to have been granted the benefits of orphan drug designation in Europe. 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.”
Commenting on the ODD status, B N Manohar, CEO 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 authorisation 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.”
Thromboangiitis obliterans or Buerger's Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterised 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 neovascularisation.
Chandru Chawla, head of Cipla New Ventures, added, “We are pleased to have been granted the benefits of orphan drug designation in Europe. 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.”