Orphan Drug Designation for Oral Fludarabine in US

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Xanthus Pharma Receives Orphan Drug Designation For Oral Fludarabine

For Treatment Of Chronic Lymphocytic Leukemia - Quick Facts

(RTTNews) - On Thursday, Xanthus Pharmaceuticals Inc. (BSGP.L) said

that the FDA has granted Orphan Drug Designation to fludarabine

phosphate oral tablets for the treatment of B-cell chronic lymphocytic

leukemia.

Xanthus licensed the exclusive right to develop and commercialize oral

fludarabine in the United States from Schering AG (now Bayer Schering

Pharma AG) in October 2006.

If oral fludarabine receives FDA approval, this designation will

entitle Xanthus to exclusive marketing rights for oral fludarabine for

the treatment of CLL for seven years following the NDA approval,

except in limited circumstances.

Chronic Lymphocytic Leukemia is a cancer of the white blood cells and

bone marrow which arises predominantly in older age groups.