Cell Therapeutics Initiates Process to Obtain Marketing Approval for Pixantrone...( ...),Health

SEATTLE, July 29 /PRNewswire-FirstCall/ -- 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.

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.

"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 s
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