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Biopharmaceuticals Regenerative Medicine FDA Regulatory

 News Release - June 24, 2010

t2cure's Cellular Therapeutic Receives Orphan Drug Designation from FDA, EMA Recommendation for Buerger's Disease

FRANKFURT, June 24, 2010 -- (Healthcare Sales & Marketing Network) -- t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the FDA has granted orphan drug designation to t2c001 for the treatment of Buerger's Disease. The Company also announced that in a concurrent application in Europe the EMA's Committee for Orphan Medicinal Products recently recommended t2c001 for orphan designation to the European Commission.

Buerger's Disease, or thromboangiitis obliterans, is a rare and severe disease affecting the blood vessels of the legs and arms. 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. t2c001 is an autologous cellular therapeutic, consisting of stem cells derived from the patient's own bone marrow. The treatment is designed to enhance the body's limited capability to restore blood flow in ischemic tissue by improving neovascularization.

"The orphan drug status for t2c001 in Buerger's Disease is an important milestone, as it provides market exclusivity for 7 years in the United States and 10 years in Europe, thereby significantly increasing the commercial potential of this groundbreaking therapy", commented Dr. Petra Rueck, CEO of t2cure.

"t2c001 has shown convincing clinical benefits in a recent pilot study including patients with Buerger's Disease, and we are working closely with regulatory authorities to receive their feedback on the pivotal study we are preparing for the end of this year."

Both the United States and Europe encourage companies to develop therapies for rare diseases, also known as "orphan diseases", for which there are no or only unsatisfactory treatment options. Apart from market exclusivity, developers of drugs that have been granted orphan drug status benefit from tax incentives and elimination of filing and registration fees. Diseases are considered rare by the FDA if they affect fewer than 200,000 patients 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 50,000 patients in the United States and in Europe, respectively. There is no established treatment available for the disease in the United States, thus there is a strong medical need for the development of drugs in this indication.

About t2cure

t2cure GmbH is a biopharmaceutical company engaged in the field of stem cell-based regenerative medicine. It develops and markets autologous bone marrow-derived progenitor cells as regenerative therapeutics for cardiovascular diseases focusing on ischemic heart disease (acute myocardial infarction and chronic ischemic heart disease), and thromboangiitis obliterans. The most advanced project (t2c001-AMI) has successfully passed Phase II of clinical development and is commercially available to treat patients in Germany.

t2cure is privately financed by Entrepreneurs Fund and Kreditanstalt fuer Wiederaufbau.


Source: t2cure

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