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DOR BioPharma's GVHD treatment receives first European Orphan Medicinal Product designation.

Dor BioPharma, Inc., Chicago, IL, announced it has received its first Orphan Medicinal Product designation from the European Agency for the Evaluation of Medicinal Products (EMEA), the European drug regulatory agency, on its drug orBec for the treatment of intestinal Graft Versus Host Disease (GVHD). The Orphan drug designation in Europe adds to the previous similar designation in the US, where orBec also has an additional designation for prevention of GVHD.

The Orphan drug designation in Europe provides for a 10-year exclusive marketing period in all European Union member countries, full or partial exemption from product registration fees, and protocol and regulatory assistance from EMEA.

The company's orBec is currently under development in the US in a pivotal multicenter phase III trial to evaluate its efficacy for the treatment of iGVHD, a frequent complication of allogeneic bone marrow transplantation. The drug is also being evaluated for the treatment of other gastrointestinal disorders including a multicenter phase II trial in the US for Crohn's disease that affects an estimated 500,000 patients.

Contact: Colin Bier, PhD - (847) 573-8990
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Title Annotation:orBec, for treating intestinal Graft Versus Host disease
Comment:DOR BioPharma's GVHD treatment receives first European Orphan Medicinal Product designation.(orBec, for treating intestinal Graft Versus Host disease)
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Mar 31, 2002
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