Italian Medicines Agency Approves NerPharMa to Manufacture Cell Therapeutics, Inc. (CTIC)'s Drug Pixantrone in European Union
6/14/2010 11:58:03 AM
SEATTLE, June 14 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone. CTI is in the process of preparing a Marketing Authorization Application ("MAA") in the European Union for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").
"We are pleased that the AIFA has approved the NerPharMa facility to manufacture pixantrone as we continue to receive positive feedback on the clinical trial results from leading clinicians in Europe and make progress in the submission of the MAA in Europe," said Craig W. Philips, President of CTI.
About Nerviano Medical Sciences (NMS)
Nerviano Medical Sciences is the largest pharmaceutical research and development facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.
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 CTI's securities. 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 European Medicines Agency ("EMEA"), that CTI may not submit its MAA to the EMEA, that the EMEA may not approve CTI's new drug application for pixantrone, 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.
Lindsey Jesch Logan
SOURCE Cell Therapeutics, Inc.