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European Commission Grants Orphan Drug Designation to Xanthus' Xanafide for the Treatment of Acute Myeloid Leukemia

Posted on: Friday, 26 October 2007, 09:00 CDT

Xanthus Pharmaceuticals, Inc., today announced that Xanafide® (amonafide malate) has been granted Orphan Drug Designation by the European Commission for the treatment of acute myeloid leukemia (AML). In December 2006, the United States Food and Drug Administration (FDA) awarded Orphan Drug Designation to Xanafide for the treatment of AML. Xanafide is currently in a pivotal Phase 3 trial in patients with secondary AML under a Special Protocol Assessment with the FDA.

"There is need for new, promising treatment options, such as Xanafide, for patients with AML, a poor-prognosis disease," said Richard Dean, Ph.D., CEO of Xanthus. "This designation is an important step in Xanthus' development plan for the candidate, and offers us potential market benefits in connection with the commercialization of Xanafide in the European Union."

The European Commission's "Orphan Medicinal Product Designation" is designed to promote the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as "life-threatening or very serious." Under European guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is the first such product candidate approved for marketing in the European Union. Orphan drug designation also allows the candidate's sponsor to seek assistance from the European Medicines Agency (EMEA) in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the Commission as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant.

About Xanafide® and Secondary AML

Xanafide (amonafide malate) is an ATP-independent topoisomerase II inhibitor that the Company is developing for the treatment of secondary acute myeloid leukemia (AML) and related disorders. Secondary AML patients have had either antecedent myelodysplastic syndrome or prior exposure to leukemogenic therapy and represent a poor prognosis population. While AML has approved treatments, no therapies are approved by FDA specifically for patients with secondary AML. In both Phase 1 and Phase 2 studies conducted in patients with poor-risk AML, amonafide exhibited promising clinical activity in patients with secondary AML and the candidate did not appear to be susceptible to multi-drug resistance. Xanafide is currently in a Phase 3 clinical trial under a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Xanafide has also been granted Orphan Drug designation by the FDA for use in the treatment of AML.

About Xanthus Pharmaceuticals, Inc.

Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule therapeutic candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. Xanthus is applying its expertise to advance its current pipeline to address significant unmet medical needs in oncology and autoimmune diseases.

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 such as the studies referred to above 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, the Euro Commission or equivalent foreign regulatory agencies; whether in connection with any approval of Xanafide, the company will obtain orphan drug exclusivity and be able to maintain it; 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

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