Xanthus Pharma Expands Onco Pipeline

Xanthus Pharmaceuticals, Inc. has licensed from Schering AG the exclusive right to develop and commercialize oral fludarabine in the U.S.

Oral fludarabine is currently marketed by Schering AG in the EU and Canada under the name, Fludara, for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL). Intravenous (IV) fludarabine has been available for several years as a single treatment for patients with CLL whose disease has relapsed following prior therapy. The IV formulation was approved in 2003 for first-line treatment, and the approval for the oral formulation was extended to first-line treatment in Europe in November 2004. Schering AG studied oral fludarabine in several trials as a first- and second-line therapy, where it showed an efficacy and tolerability profile similar to that of the IV formulation.

“We believe oral fludarabine is an excellent strategic fit with our expanding oncology pipeline. With the convenience of oral dosing added to the current standard of care for refractory CLL patients, we believe oral fludarabine represents a relatively low-risk, near-term commercial opportunity for Xanthus,” stated Robert L. Capizzi, M.D., senior vice president and chief medical officer at Xanthus.

Under the terms of the agreement, Xanthus paid Schering an upfront licensing fee and has agreed to make payments upon the achievement of predetermined milestones, as well as pay a royalty to Schering on net sales. Additional financial terms were not disclosed.