CELL THERAPEUTICS INC 
By
"With a focus on cutting-edge oncology drug products, CTI aims to complete
its transition from a research-based organization to a leading commercial
oncology company," said
Targeted 2009 Milestones:
ZEVALIN -- First- line consolidation indication approval for Zevalin with
a target decision date by the FDA of
PIXANTRONE -- Based on preliminary results from its phase III extend trial
for Pixantrone reported on
OPAXIO -- Potential Marketing Authorization Application approval by the
European Medicines Agency or EMEA for OPAXIO for first-line treatment of
patients with non-small cell lung cancer (NSCLC). If Novartis elects to
commercialize OPAXIO in
Continued improvement of our capital structure through a comprehensive
recapitalization plan intended to help CTI regain compliance with the Nasdaq
listing standards, and which may include additional equity or debt offerings,
and the reduction of our outstanding indebtedness, through the previously
announced potential tender offer for a portion of our outstanding convertible
notes or otherwise as disclosed on
Review of 2008 Key Accomplishments:
Entered into an agreement with Bayer Schering Pharma to gain access to its positive phase III Zevalin First-line Indolent Trial (FIT) data for submission to the FDA in connection with the Zevalin sBLA.
Successful pre-sBLA meeting with FDA and submission of sBLA for expansion
of the label for Zevalin for use in first-line consolidation treatment for
non-Hodgkin's lymphoma. FDA has granted the sBLA priority review shortening
the timeframe for FDA review from 10 months to six months with a target
decision date of
Formed RIT Oncology, LLC, a 50/50 joint venture with Spectrum, by
contributing all assets exclusively related to the Zevalin product in exchange
for
Successfully achieved the primary efficacy endpoint in our pivotal phase III study of pixantrone in relapsed aggressive non-Hodgkin's lymphoma and have scheduled pre-NDA meeting with the FDA in early 2009.
Submitted a marketing authorization application (MAA) to the European Medicines Agency for OPAXIO for first-line treatment of patients with non- small cell lung cancer with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). OPAXIO is a drug candidate which is exclusively partnered with Novartis.
Reduced net cash used for operating activities for the reported nine
months ended
Raised significant operating capital to fund operations resulting in
advancement of our product portfolio and strategic initiatives in a
challenging economic and capital market environment. Even with this additional
capital, CTI expects that it will need to access additional capital in 2009
through potential funding from partnerships or joint ventures, public or
private equity financings, debt financings or restructurings, dispositions of
assets or through other means in order to fund its continued operations. CTI
could also choose to raise additional capital through the exercise of a sale
option, exercisable in its sole discretion from
Strengthened executive and commercial team with addition of
About Cell Therapeutics, Inc.
Headquartered in
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. Specifically, the risks and
uncertainties that could affect future results include the risks associated
with preclinical and clinical developments in the biopharmaceutical industry
in general, the determinations by regulatory, patent and administrative
governmental authorities, competitive factors, technological developments, the
potential for Zevalin FIT data to be acceptable to the FDA for an expanded
indication or any other indication, the risk that if label expansion of
Zevalin is approved, it may not result in a significant market increase for
the drug due to the presence of other treatment options, failure to gain
market acceptance and other factors, the success of the joint venture in
commercializing and developing Zevalin, the ability of the joint venture to
accelerate top-line revenues in the near-term, the ability to integrate
Zevalin into Spectrum's commercial, marketing and medical affairs teams, the
results of complete safety and progression free survival information for
pixantrone which is still being assembled, the potential failure of pixantrone
to prove safe and effective for treatment of relapsed aggressive NHL as
determined by the FDA, the determination by the FDA that the PIX301 trial is
insufficient to support an NDA filing, marketing approval review of the OPAXIO
MAA may not result in a marketing approval in
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
http://www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T : 206.272.4347
F : 206.272.4434
E: invest@ctiseattle.com
http://www.CellTherapeutics.com/investorsSOURCE Cell Therapeutics, Inc.
