Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL. CTI anticipates the formal Marketing Authorization Application (MAA) filing in 2010 following approval of the pediatric investigation plan which was submitted to the EMEA earlier this month. CTI would be granted 10 year market exclusivity in Europe if the MAA is approved. In the United States, the pixantrone New Drug Application (NDA) for the treatment of relapsed or refractory aggressive NHL is currently under review for approval by the Food and Drug Administration (FDA).
Orphan drug designation is available in Europe for medical treatments and drugs intended to treat life-threatening or chronically debilitating conditions. Orphan drug designation can confer numerous benefits to companies developing such treatments, including regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and assistance with clinical trial design.
"With the pixantrone NDA review progressing well in the United States, we are moving forward with the marketing approval application process in Europe and believe that orphan drug designation in Europe, if granted, could provide important regulatory, financial and commercial advantages for CTI," stated Craig W. Philips, President of CTI.