Navigation Links
European Medicines Agency Grants Cell Therapeutics Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma (DLBCL)
Date:12/21/2009

SEATTLE, Dec. 21 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin's lymphoma. CTI expects to file the Marketing Authorization Application (MAA) in Europe for approval of pixantrone in mid-2010 and would be granted 10 year market exclusivity if it is approved. In the U.S., the Food & Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) plans to review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) on February 10, 2010. Pixantrone is a fast track designated product in the U.S. and is in review for approval by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.

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.

"Orphan drug designation for pixantrone in Europe demonstrates that there is clear unmet medical need for patients with DLBCL," stated Craig W. Philips, President of CTI. "We will continue to work with the EMEA to move our application forward in Europe expeditiously as we prepare for potential commercial launch of pixantrone in the United States."

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.

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, 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


    Media Contact:
    Dan Eramian
    T: 206.272.4343
    C: 206.854.1200
    E: deramian@ctiseattle.com
    www.CellTherapeutics.com/media.htm

    Investors Contact:
    Ed Bell
    T: 206.282.7100
    Lindsey Jesch
    T: 206.272.4347
    F: 206.272.4434
    E: invest@ctiseattle.com
    www.CellTherapeutics.com/investors

    Medical Information Contact:
    T: 800.715.0944
    E: info@askarm.com

SOURCE Cell Therapeutics, Inc.


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Surveyed European Oncologists Cite Cost Most Frequently as the Factor Preventing Their Use of Avastin for Non-Small-Cell Lung Cancer
2. European Radiotherapy Pioneers Deliver First Varian RapidArc(TM) Treatment for Rectal Carcinoma Patient
3. A Drugs Activity Against MRSA is Among the Top Factors That Influences European Physician Antibiotic Selection for Treating Skin and Skin Structure Infections
4. Frost & Sullivan Product Quality Leadership Award in the European Ultrasound Market Conferred on SonoScape for S8
5. Reportlinker Adds European Markets for Drug Eluting and Bare Metal Stents 2009 (15 Countries)
6. Reportlinker Adds Radiopharmaceuticals - A US and European Market Analysis
7. Frost & Sullivan: Western European Markets Confirm Undisputed Convenience and Cost Benefit of Custom Procedure Trays
8. European Lung Cancer Screening Trial Demonstrates New Inexpensive Strategy for Improving Accuracy of Diagnosis
9. Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation
10. BridgePoint Medical(R) Receives European CE Mark for Stingray(R) and CrossBoss(TM) for Opening Completely Blocked Arteries
11. Solta Medical Announces New Fraxel re:store(R) Dual Laser System, Receives CE Mark for European Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... -- Site Profile: --> ... Speech Recognition People, announced their latest primary healthcare case study where ... turnaround times and to save the practice money. Site ... Challenge: --> ,- Wirral CCG ,- VoicePower ... doctors ,- Wirral CCG ,- VoicePower client since 2013 ...
(Date:2/4/2016)... 2016  Edwards Lifesciences Corporation (NYSE: EW ), ... disease and critical care monitoring, announced today that it ... with Morgan Stanley & Co. LLC to repurchase $325 ... of the Company,s previously authorized program to repurchase up ... --> --> Under ...
(Date:2/4/2016)... , Feb. 4, 2016  SciClone Pharmaceuticals, Inc. ... it has entered into a settlement agreement with ... fully resolving the SEC,s investigation into possible violations ... the terms of the settlement agreement, SciClone has ... including disgorgement, pre-judgment interest and a penalty.  This ...
Breaking Medicine Technology:
(Date:2/5/2016)... , ... February 05, 2016 , ... ... the addition of micro-needling services in their Napa Valley office. The technique utilizes ... Plastic Surgery Associates, Dr. Canales and Dr. Furnas, are part of only a ...
(Date:2/5/2016)... ... , ... US Sports Camps , official operators of Nike Yoga Camps, ... yoga training. ChildLight Yoga Studio is centrally situated in the picturesque New England city ... Studio founder Lisa Flynn expresses her excitement, “We are thrilled to be partnering with ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Boar’s Head ... just in time for this weekend’s Big Game. Take the stress out of your ... will keep your guests happy at every stage of the game. , “The key ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Ben ... that it is now welcoming orthodontist, Dr. Amanda Cheng, to the practice. With ... of oral health care, including general dentistry, cosmetic treatments, periodontics, implant dentistry ...
(Date:2/5/2016)... ... February 05, 2016 , ... On ... Rare Diseases, a continuing medical education (CME) event presented by the Association for ... kind—and a first for ACCORD, whose mission is to provide education, tools, and ...
Breaking Medicine News(10 mins):