CAMBRIDGE, Mass., Oct. 3 /PRNewswire/ -- Xanthus Pharmaceuticals, Inc., a privately held oncology drug development company, today announced that the Company has licensed from Schering AG the exclusive right to develop and commercialize oral fludarabine in the United States.
Oral fludarabine is currently marketed by Schering AG in the European Union 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 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 clinical trials as a first- and second-line therapy, where it exhibited 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.
“With a strong body of clinical efficacy and tolerability data already behind it, oral fludarabine is now our most advanced clinical candidate,” said Richard T. Dean, Ph.D., Chief Executive Officer of Xanthus. “We plan to seek a meeting with the FDA to determine our path to commercialization for this promising new candidate.”
“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 A. Boss, Ph.D., Xanthus’ Chief Business Officer. “Furthermore, pharmacoeconomic data from the EU, where oral fludarabine is marketed by Schering AG, suggest that the oral formulation is more cost-effective than IV therapy because it eliminates the need for patient visits to the hospital to receive IV therapy.”
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 United States. For these rights, 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.
Oral Fludarabine and the U.S. Market Opportunity
To date, oral fludarabine has been developed in the European Union and Canada for the treatment of B-cell chronic lymphocytic leukemia (CLL), and Xanthus believes that with future study, it may also prove to be useful for the treatment of other B-cell malignancies, including Non-Hodgkin’s lymphoma (NHL). CLL is a cancer of the white blood cells and bone marrow and it arises predominantly in older age groups. CLL is the most prevalent leukemia and according to the American Cancer Society, approximately 10,000 new CLL cases were diagnosed in the United States in 2005.
About Xanthus Pharmaceuticals, Inc.
Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule oncology candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.
Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at http://www.xanthus.com.
NOTE: Fludara® is a registered trademark of Schering AG.
Contacts:
Kari Watson, MacDougall Biomedical Communications, Inc. - kwatson@macbiocom.com or (508) 647-0209
Lisa Terry, Xanthus Pharmaceuticals, Inc. - lisa.terry@xanthus.com or (617) 225-0522, x 105
Source: Xanthus Pharmaceuticals, Inc.
