Quick facts about CTIC's latest development Print E-mail
By Staff and Wire Reports   
Tuesday, 29 September 2009 02:47

Cell Therapeutics, Inc. (NASDAQ: CTIC) announced in the middle of the night (Tuesday morning) that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for Pixantrone (BBR 2778). CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive Non-Hodgkin's Lymphoma (NHL).

Pixantrone (BBR 2778), is the company's novel topoisomerase II inhibitor 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. The drug has been granted fast track status designation.

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.

Shares of Cell Therapeutics, Inc. closed at $1.27+0.03 (2.42%) on Monday.

 




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