SEATTLE, Dec. 21 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (“CTI”) announced today that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin’s lymphoma. CTI expects to file the Marketing Authorization Application (MAA) in Europe for approval of pixantrone in mid-2010 and would be granted 10 year market exclusivity if it is approved. In the U.S., the Food & Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) plans to review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin’s lymphoma (NHL) on February 10, 2010. Pixantrone is a fast track designated product in the U.S. and is in review for approval by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
“Orphan drug designation for pixantrone in Europe demonstrates that there is clear unmet medical need for patients with DLBCL,” stated Craig W. Philips, President of CTI. “We will continue to work with the EMEA to move our application forward in Europe expeditiously as we prepare for potential commercial launch of pixantrone in the United States.”
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory aggressive NHL as determined by the FDA or EMEA, and the possibility that the orphan drug designation, if granted, may not provide numerous benefits to CTI (including, regulatory assistance, reduced regulatory fees associated with applying for marketing approval, or assistance with clinical trial design), CTI’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI’s filings with the Securities and Exchange Commission including, without limitation, CTI’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise
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