FDA Approves NerPharMa to Manufacture Cell Therapeutics' Drug Pixantrone
SEATTLE, March 8, 2010 /PRNewswire via COMTEX/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the U.S. Food and Drug Administration ("FDA") has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product. CTI has a New Drug Application ("NDA") under review at the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. As previously announced, the FDA's Oncologic Drugs Advisory Committee ("ODAC") will review the NDA for pixantrone on March 22, 2010 and the FDA is expected to make a final decision on approval by April 23, 2010.
"FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," said Craig W. Philips, President of CTI.
About Nerviano Medical Sciences (NMS)
Nerviano Medical Sciences is the largest pharmaceutical R&D 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 FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that the FDA may not approve the NDA 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.