DOR BioPharma's GVHD treatment receives first European Orphan Medicinal Product designation.
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
|Printer friendly Cite/link Email Feedback|
|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)|
|Article Type:||Brief Article|
|Date:||Mar 31, 2002|
|Previous Article:||Organogenesis receives FDA 510(k) clearance to market rotator cuff repair patch.|
|Next Article:||MTF, Spineology enter into agreement on advanced bone graft technology.|