Thursday, January 3, 2008

Xanthus Receives Orphan Drug Designation for Oral Fludarabine for the Treatment of CLL

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 3, 2008 - Xanthus Pharmaceuticals, Inc., a privately-held oncology and autoimmune disease drug development company, today announced 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.

"We are pleased to receive Orphan Drug Designation for oral fludarabine," said Richard Dean, Ph.D., CEO 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."

The FDA grants Orphan Drug Designation to products that are intended to address diseases affecting fewer than 200,000 persons in the United States. 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. Orphan Drug Designation provides companies with financial and regulatory incentives to pursue less common diseases.

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