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Published on 9/6/2006 in the Prospect News Biotech Daily.

XOMA's Neuprex granted orphan status in Europe

By Lisa Kerner

Charlotte, N.C., Sept. 6 - XOMA Ltd. said the European Commission granted orphan medicinal product designation to its drug Neuprex (opebacan) in meningococcal disease, a bacterial infection that affects young children.

The company is also seeking approval under the European Medicines Agency's (EMEA) exceptional circumstances mechanism.

"We are proceeding as quickly as possible with our marketing assessment for the drug in Europe, and we are going to be working closely with the EMEA to determine whether the extensive Neuprex clinical trials database will be sufficient to support a marketing authorization in Europe," president and chief executive officer of the Berkeley, Calif. Pharmaceutical company Jack Castello said in a news release.


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