New Delhi: Stempeutics Research, a gathering organization of Manipal Education & Medical Group and a Joint Venture with Cipla Group, reported a week ago that the European Medicines Agency (EMA) has conceded Orphan Drug Designation (ODD) for its medication Stempeucel® for the treatment of Thromboangiitis Obliterans.
Thromboangiitis obliterans or Buerger’s ailment is an uncommon and serious sickness influencing the veins of the legs. It is described by irritation and impediment of the vessels of limits bringing about diminished blood stream to these zones, therefore prompting serious agony and ulcers or rot, which at long last may oblige removal
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, Mr BN 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 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 Mr 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.”