EMA grants Orphan Drug Designation to Stempeucel for treatment of Thromboangiitis Obliterans

Jun 2 2015

- The First Allogeneic Stem Cell Drug to be Granted ODD Status by European Medicinal Agency (EMA) for Treating Thromboangiitis Obliterans

- Stempeucel Will Offer New Hope to Patients Suffering From "Thromboangiitis Obliterans" (Also Known as Buerger's Disease), a Major Unmet Medical Need in Europe

- Prevalence of "Thromboangiitis Obliterans" is Estimated to be 2 per 10,000 Persons in the European Community

Stempeutics Research, a group company of Manipal Education & Medical Group and a joint venture with Cipla Group, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation for its drug Stempeucel® for the treatment of Thromboangiitis Obliterans. 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, 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."