Xanthus Announces Oral Fludarabine NDA Accepted for Review by U.S. FDA

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January 22, 2008 09:30 AM Eastern Time

Xanthus Announces Oral Fludarabine NDA Accepted for Review by U.S. FDA

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Xanthus Pharmaceuticals, Inc., a

privately-held oncology and autoimmune disease drug development company, today

announced that its New Drug Application (NDA) for fludarabine phosphate oral

tablets (oral fludarabine) was accepted for filing by the U.S. Food and Drug

Administration (FDA) for the treatment of relapsed B-cell chronic lymphocytic

leukemia (CLL). Filing of the NDA indicates that the registration package is

sufficiently complete to allow for a thorough review of the data supporting the

safety profile and effectiveness of oral fludarabine. Earlier this month Xanthus

announced that the FDA granted Orphan Drug Designation for oral fludarabine for

B-cell CLL. 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 of 2006.

" Currently patients with chronic CLL undergoing fludarabine treatment in the

United States receive the drug intravenously. Acceptance of the NDA application

is a critical next step in our effort to provide these individuals with a more

patient-friendly delivery option, " said 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. "

About CLL and Oral Fludarabine

Chronic lymphocytic leukemia (CLL) is a cancer of the white blood cells and bone

marrow which arises predominantly in older age groups. CLL is the most prevalent

leukemia and according to the American Cancer Society, approximately 15,300 new

CLL cases were diagnosed in the United States in 2007. Oral fludarabine is

currently marketed by Bayer Schering Pharma AG in the European Union and Canada

for the treatment of relapsed B-cell chronic lymphocytic leukemia. Intravenous

(IV) fludarabine has been widely available for a number of years in the United

States and other countries as a treatment for patients with CLL. The approval

for the oral formulation was extended to first-line treatment in Europe in

November 2004. Bayer Schering Pharma 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.

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