- Xanthus Embarks on Path for Commercialization in the United States -
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(R), 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(R) 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.
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Related links:
http://www.xanthus.com
CONTACT:
Lisa Terry of Xanthus Pharmaceuticals, Inc.,
+1-617-225-0522, ext. 105, lisa.terry@xanthus.com; or Kari Watson
of MacDougall Biomedical Communications, Inc., +1-508-647-0209,
kwatson@macbiocom.com
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