• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Xanthus Receives Orphan Drug Designation for Oral Fludarabine for the Treatment of CLL

Posted on: Thursday, 3 January 2008, 12:00 CST

Xanthus Pharmaceuticals, Inc., a privately-held oncology and autoimmune disease drug development company, today announced that the FDA has granted Orphan Drug Designation to fludarabine phosphate oral tablets for the treatment of B-cell chronic lymphocytic leukemia. 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 2006.

"We are pleased to receive Orphan Drug Designation for oral fludarabine," said Richard 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."

The FDA grants Orphan Drug Designation to products that are intended to address diseases affecting fewer than 200,000 persons in the United States. If oral fludarabine receives FDA approval, this designation will entitle Xanthus to exclusive marketing rights for oral fludarabine for the treatment of CLL for seven years following the NDA approval, except in limited circumstances. Orphan Drug Designation provides companies with financial and regulatory incentives to pursue less common diseases.

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 (CLL). 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.

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 www.xanthus.com.

This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes,""anticipates,""plans,""expects,""estimates,""intends,""should,""could,""will,""may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus' actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies will be indicative of results obtained in future clinical trials or warrant additional trials; whether products based on Xanthus' technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patent and patent applications owned or licensed by Xanthus will protect the Company's technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.

Source: Business Wire

More News in this Category