SEATTLE, July 29 Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it was notified by the European Medicines Agency ("EMEA") that pixantrone is eligible to be submitted for a Marketing Authorization Application ("MAA") through the EMEA's centralized procedure. The centralized review process provides for a single coordinated review for approval of pharmaceutical products that is conducted by the EMEA on behalf of all European Union ("EU") member states. The EMEA also designated pixantrone as a New Active Substance ("NAS"); if approved, compounds designated as an NAS receive a 10-year market exclusivity period in EU member states. CTI will request a meeting with the EMEA to discuss the submission of the MAA for pixantrone to treat aggressive non-Hodgkin's lymphoma ("NHL") in the EU member states.
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CTI completed the submission of the New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for pixantrone to treat relapsed or refractory, aggressive NHL in June 2009 and requested priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is currently available in Europe on a named-patient basis.
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"Initiating the approval process for pixantrone in Europe is another significant milestone for CTI," said James A. Bianco, M.D., Chief Executive Officer of CTI. "Additionally, being granted SME status will support and reduce our cost of regulatory filings in Europe. More importantly, it will assist us in our submission of pixantrone for EU approval."
The SME program is an initiative by the EMEA that is dedicated to addressing the needs of small and medium size companies developing medicinal products in Europe. Companies granted SME status are able to seek assistance, information and training from dedicated EMEA personnel, particularly in support of Marketing Authorization Applications (MAA). In addition, SME status may result in reduced or deferred fees associated with marketing authorization applications, scientific advice and inspections. The EMEA also provides for translation of certain required documents. Restricted to companies based in the European Union, SME status has been granted to CTI Life Sciences Limited, a wholly-owned subsidiary of CTI, based in London, UK.
About Pixantrone
Pixantrone (BBR 2778) is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
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.
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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, including whether CTI will become profitable and the development of pixantrone, 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 (including the failure to achieve the overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3/4 adverse events, including cardiac disorders) for the treatment of relapsed or refractory aggressive NHL as determined by the FDA, the potential that the EMEA does not grant the MAA for pixantrone, the potential that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in six months or in the fourth quarter of 2009, 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.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: [email protected] www.CellTherapeutics.com/press_room Investors Contact: Ed Bell T: 206.282.7100 Lindsey Jesch T: 206.272.4347 F: 206.272.4434 E: [email protected] www.CellTherapeutics.com/investors Medical Information Contact: T: 800.715.0944 E: [email protected]
SOURCE Cell Therapeutics, Inc.
