Navigation Links
Cell Therapeutics Initiates Process to Obtain Marketing Approval for Pixantrone in Europe
Date:7/28/2009

SEATTLE, July 29 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it 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 U.S. 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, M.D., 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 program 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 Marketing Authorization Applications (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, UK.

About Pixantrone

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. 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. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.

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, including whether CTI will become profitable and the development of pixantrone, and the trading price of CTI's securities. 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 (including the failure to achieve the overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3/4 adverse events, including cardiac disorders) for the treatment of relapsed or refractory aggressive NHL as determined by the FDA, the potential that the EMEA does not grant the MAA for pixantrone, the potential that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in six months or in the fourth quarter of 2009, 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/press_room

    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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cell Therapeutics, Inc. Announces Closing of Public Offering of Common Stock and Warrants
2. Raptor Pharmaceuticals Corp. and TorreyPines Therapeutics, Inc. Announce Merger Agreement
3. Orexigen(R) Therapeutics Prices Public Offering of Common Stock
4. Cell Therapeutics, Inc. Announces Public Offering of Common Stock and Warrants
5. Orexigen(R) Therapeutics Announces Proposed Public Offering of Common Stock
6. Oxygen Biotherapeutics, Inc. Announces Closing of Offer to Acquire Warrants
7. Cornerstone Therapeutics David Price Named 2009 Chief Financial Officer of the Year by the Triangle Business Journal
8. Echo Therapeutics to Present at Jessup & Lamont 2009 Growth Stock Conference
9. The Leukemia & Lymphoma Society and FORMA Therapeutics Enter Collaboration to Bring New Therapies to Patients Faster
10. Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product
11. QuikByte Software, Inc. and Sorrento Therapeutics, Inc. Announce Merger Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... ... March 28, 2017 , ... ... corrosive ions found in power plant water and steam. , Chlorides and sulfates ... and boilers, leading to extensive maintenance and unplanned shutdowns. Monitoring these ions at ...
(Date:3/28/2017)... (PRWEB) , ... March 28, 2017 , ... ... more patients desire to achieve the “perfect smile.” The National Association of Dental ... well as what dentists should be aware of when utilizing dental laboratories and ...
(Date:3/28/2017)... ... March 28, 2017 , ... The Lice Treatment ... City March 13-16, was a busy spot this year. Liz Solovay and Adrian ... for preventing outbreaks among camp communities during the upcoming 2017 camping season. “Lice ...
(Date:3/28/2017)... (PRWEB) , ... March 28, 2017 , ... Thank you ... Diego on February 8-10. , This event was exclusive to providers and offered ... , The meeting took place at the Manchester Grand Hyatt where attendees gathered for ...
(Date:3/27/2017)... ... ... New patients who have sleep apnea in Aurora, CO, can now ... Sleep apnea is often left untreated because patients are not familiar with common symptoms ... , Dr. Braasch seeks to raise awareness of sleep apnea in Aurora, CO, and ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... 2017   Pulmatrix, Inc . (NASDAQ: PULM), a clinical ... pulmonary diseases, today announced that it has added two experts ... asthma to its Scientific Advisory Board . ... B. Moss , MD, former chief of the Pediatric Pulmonary ... Center at Stanford University, and David ...
(Date:3/27/2017)... FRANCISCO , March 27, 2017 ... expected to reach USD 16.0 billion by 2025, according ... The growing prevalence of chronic diseases is anticipated to ... chemistry analyzers, which thereby widens the scope for growth ... geriatric and bariatric population, which is highly susceptible to ...
(Date:3/27/2017)... BOSTON , March 27, 2017 ... pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), ... commercialization of innovative therapies based upon tetracycline chemistry, ... sarecycline for the treatment of moderate to severe ... Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived ...
Breaking Medicine Technology: