CAMBRIDGE, Mass. Xanthus Pharmaceuticals has received orphan drug designation from the Food and Drug Administration for its fludarabine phosphate oral tablet, which is used to treat B-cell chronic lymphocytic leukemia, a cancer of the white blood cells and bone marrow.
“We are pleased to receive Orphan Drug Designation for oral fludarabine,” said Richard Dean, chief executive officer of Xanthus. “With the convenience of oral dosing and a strong body of clinical efficacy and tolerability data already behind it, we believe oral fludarabine represents an exciting opportunity for Xanthus.”
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 application approval, except in limited circumstances.
Xanthus licensed the exclusive right to develop and commercialize oral fludarabine from Schering AG (now Bayer Schering Pharma AG) in October 2006.