FRANKFURT, June 24, 2010 t2cure GmbH, a biopharmaceuticalcompany developing and marketing stem cell-based regenerative therapies,announced today that the FDA has granted orphan drug designation to t2c001for the treatment of Buerger's Disease. The Company also announced that in aconcurrent application in Europe the EMA's Committee for Orphan MedicinalProducts recently recommended t2c001 for orphan designation to the EuropeanCommission.
Buerger's Disease, or thromboangiitis obliterans, is a rare and severedisease affecting the blood vessels of the legs and arms. It is characterizedby inflammation and occlusion of the vessels of extremities resulting inreduced blood flow to these areas, thus leading to severe pain and ulcers ornecrosis, which finally may require amputation. t2c001 is an autologouscellular therapeutic, consisting of stem cells derived from the patient's ownbone marrow. The treatment is designed to enhance the body's limitedcapability to restore blood flow in ischemic tissue by improvingneovascularization.
"The orphan drug status for t2c001 in Buerger's Disease is an importantmilestone, as it provides market exclusivity for 7 years in the United Statesand 10 years in Europe, thereby significantly increasing the commercialpotential of this groundbreaking therapy", commented Dr. Petra Rueck, CEO oft2cure.
"t2c001 has shown convincing clinical benefits in a recent pilot studyincluding patients with Buerger's Disease, and we are working closely withregulatory authorities to receive their feedback on the pivotal study we arepreparing for the end of this year."
Both the United States and Europe encourage companies to developtherapies for rare diseases, also known as "orphan diseases", for which thereare no or only unsatisfactory treatment options. Apart from marketexclusivity, developers of drugs that have been granted orphan drug statusbenefit from tax incentives and elimination of filing and registration fees.Diseases are considered rare by the FDA if they affect fewer than 200,000patients in the United States (or less than five in 10,000 people in the EU,under European legislation).
Buerger's Disease, or thromboangiitis obliterans, affects about 50,000patients in the United States and in Europe, respectively. There is noestablished treatment available for the disease in the United States, thusthere is a strong medical need for the development of drugs in thisindication.
t2cure GmbH is a biopharmaceutical company engaged in the field of stemcell-based regenerative medicine. It develops and markets autologous bonemarrow-derived progenitor cells as regenerative therapeutics forcardiovascular diseases focusing on ischemic heart disease (acute myocardialinfarction and chronic ischemic heart disease), and thromboangiitisobliterans. The most advanced project (t2c001-AMI) has successfully passedPhase II of clinical development and is commercially available to treatpatients in Germany.
t2cure is privately financed by Entrepreneurs Fund and Kreditanstalt fuerWiederaufbau.For more information on the Company, visit our websitehttp://www.t2cure.com Company contact: Dr. Petra Rueck t2cure GmbH Bettinastrasse 35-37 D-60325 Frankfurt am Main Tel: +49-69-75-61-46-870 Fax: +49-69-75-61-46-879 Email: firstname.lastname@example.org Media contact: Frank Butschbacher Investor Relations & Communications http://www.butschbacher.net +43-650-7844940 email@example.com
SOURCE t2cure GmbH