Cell Therapeutics, Inc 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 US 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, 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 programme 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 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.
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.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.