Xechem International Inc. (fka XKEM)

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Maybe this will answer your questions? I'm don't know the specific definition of an Orphan Drug.

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Oct. 4, 2005--Xechem International, Inc. (OTC BB: XKEM) Xechem International announced today that its wholly owned subsidiary, Xechem UK Ltd., has received Orphan Drug designation from the European Medicine Evaluation Agency (EMEA) for NIPRISAN (now known as NICOSAN(TM)/HEMOXIN(TM)), a phytopharmaceutical product that has shown efficacy in the treatment of Sickle Cell Disease. The designation covers all 25 countries that comprise the European Union. Similar Orphan Drug status was previously granted to Xechem by the U.S. Food and Drug Administration.

http://www.bioportfolio.com/oct_05/05_10_2005/Xechem_s_Orphan_Drug_Status.html