Oral fludarabine is currently marketed by Schering AG in the EU and Canada under the trade name, Fludara, for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL).
Intravenous (IV) fludarabine has been widely available for a number of years as a single treatment for patients with CLL.
Schering AG studied oral fludarabine in several clinical trials, where it exhibited an efficacy and tolerability profile similar to that of the IV formulation.
“We believe oral fludarabine offers a number of important advantages over IV fludarabine for the treatment of CLL. Schering AG's clinical studies not only demonstrated that oral fludarabine was effective and well tolerated, but also that it was more convenient than IV administration,” said Michael Boss, Xanthus' Chief Business Officer.
Under the terms of the licensing agreement with Schering AG, Xanthus will have the exclusive right to develop and commercialize the oral formulation of fludarabine in the US. For these rights, Xanthus paid Schering an upfront licensing fee and has agreed to make payments upon the achievement of predetermined milestones.