Healthcare Industry News: T Cell Therapeutics
News Release - September 29, 2009
Cell Therapeutics Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkin's Lymphoma (NHL)
SEATTLE, Sept. 29 (Healthcare Sales & Marketing Network) -- 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.
About Pixantrone
Pixantrone (BBR 2778), is a 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. 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. Pixantrone has been granted fast track status designation.
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.
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_news.htm
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 and the trading price of the securities of CTI. 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 for the treatment of relapsed or refractory aggressive NHL as determined by the FDA or EMEA, the possibility that CTI will not make the formal MAA filing in 2010 following approval of the pediatric investigation plan, the possibility that the pediatric investigation plan will not be approved, the possibility that orphan drug designation will not be granted by the EMEA, and the possibility that the orphan drug designation, if granted, may not provide numerous benefits to CTI (including, regulatory assistance, reduced regulatory fees associated with applying for marketing approval, or assistance with clinical trial design), 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.
Source: Cell Therapeutics
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
