German Institute for Quality and Efficiency in Health Care (IQWiG) Publishes Dossier Evaluation within Early Benefit Assessment

 German Institute for Quality and Efficiency in Health Care (IQWiG) Publishes
    Dossier Evaluation within Early Benefit Assessment Process of PIXUVRI®

PR Newswire

SEATTLE, March 1, 2013

SEATTLE, March 1, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today announced that the private German Institute for Quality
and Efficiency in Health Care (IQWiG) has published its report on the
preliminary benefit assessment of PIXUVRI^® (pixantrone) as a monotherapy for
the treatment of adult patients with multiply relapsed or refractory
aggressiveB-cell non-Hodgkin lymphoma (NHL). In May 2012, the European
Commission (EC) granted conditional marketing authorization for PIXUVRI in the
European Union (E.U.) for this indication based on the results of the EXTEND,
or PIX301, pivotal randomized Phase 3 clinical trial. In its evaluation of the
manufacturer submission, IQWiG concluded that no additional benefit could be
determined for PIXUVRI versus the comparator therapies assigned by Germany's
Federal Joint Committee (G-BA), the ultimate authority in determining
reimbursement for drugs in Germany. Public comment on IQWiG's assessment
report can be submitted to the G-BA until March 22, 2013. The G-BA is
scheduled to hold a public hearing on April 8 or 9, 2013 and then decide on
the innovation score and the additional benefit vs. the self-assigned
comparator therapies in the second quarter of 2013. IQWiG's current assessment
has no immediate impact on the reimbursement of PIXUVRI or physician's ability
to prescribe this new treatment in Germany.

"PIXUVRI is the first medicinal product approved in the E.U. for treatment of
patients with multiply relapsed or refractory aggressive NHL that addresses an
unmet medical need," said James A. Bianco, M.D., President and CEO of CTI.
"Importantly, the IQWiG assessment has no current impact on a physician's
ability to prescribe PIXUVRI for patients in Germany. The reimbursement
process in Germany is designed to allow companies and external experts in
treatment of the disease to have an opportunity to provide clarification on
the benefits of the drug to G-BA during the hearing process. The G-BA will
then make a final independent decision as to whether or not there is an
additional benefit. We believe PIXUVRI offers patients suffering from
aggressive NHL a safe and effective therapy, where there currently is no
standard of care. Throughout this process, we plan to highlight to the G-BA
that their decision should consider the full PIXUVRI dataset and that they
should not limit the comparison to some selected and mostly older treatments
that are rarely used."

About PIXUVRI (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and
physiochemical properties. Unlike related compounds,PIXUVRI forms stable DNA
adducts and in preclinical models has superior anti-lymphoma activity compared
to related compounds. PIXUVRI was structurally designed so that it cannot bind
iron and perpetuate oxygen radical production or form a long-lived hydroxyl
metabolite -- both of which are the putative mechanisms for anthracycline
induced acute and chronic cardiotoxicity. These novel pharmacologic properties
allow PIXUVRI to be administered to patients with near maximal lifetime
exposure to anthracyclines without unacceptable rates of cardiotoxicity.

InMay 2012, the European Commission (EC) granted conditional marketing
authorization for PIXUVRI as a monotherapy for the treatment of adult patients
with multiply relapsed or refractory aggressiveNHL. The benefit of PIXUVRI
treatment has not been established in patients when used as fifth line or
greater chemotherapy in patients who are refractory to last therapy.The
Summary of Product Characteristics (SmPC) has the full prescribing
information, including the safety and efficacy profile of PIXUVRI in the
approved indication. TheSmPCis available

CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and
rituximab with gemcitabine and rituximab in the setting of aggressive B-cell
NHL. PIXUVRI does not have marketing approval inthe United States.

About Non-Hodgkin Lymphoma

In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL
every year.^1,2 ^NHL is caused by the abnormal proliferation of lymphocytes,
cells key to the functioning of the immune system. It usually originates in
lymph nodes and spreads through the lymphatic system. NHL can be broadly
classified into two main forms—aggressive and indolent NHL. Aggressive NHL is
a rapidly growing form of the disease that moves into advanced stages much
faster than indolent NHL, which progresses more slowly.

There are many subtypes of NHL, but aggressive B-cell NHL is the most common
and accounts for about 50 percent of NHL cases.^2 After initial therapy for
aggressive NHL with anthracycline-based combination therapy, one-third of
patients typically develop progressive disease.^3 Approximately half of these
patients are likely to be eligible for intensive second-line treatment and
stem cell transplantation, although 50 percent are expected not to respond.^3
For those patients who fail to respond or relapse following second-line
treatment, treatment options are limited, and usually palliative only.^3

About Conditional Marketing Authorization

Similar to accelerated approval regulations intheUnited States, conditional
marketing authorizations are granted in the E.U. to medicinal products with a
positive benefit/risk assessmentthat address unmet medical needs and whose
availability would result in a significant public health benefit. A
conditional marketing authorization is renewable annually. Under the
provisions of the conditional marketing authorization for PIXUVRI, CTI will be
required to complete a post-marketing study aimed at confirming the clinical
benefit previously observed.

The European Medicines Agency's (the "EMA")Committee for Medicinal Products
for Human Usehas accepted PIX306, CTI's ongoing randomized controlled Phase 3
clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in
patients who have relapsed after one to three prior regimens for aggressive
B‑cellNHLand who are not eligible for autologous stem cell transplant. As a
condition of approval, CTI has agreed to have available the PIX306 clinical
trial results byJune 2015.

About Cell Therapeutics, Inc.

CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the
development and commercialization of an integrated portfolio of oncology
products aimed at making cancer more treatable. CTI is headquartered in
Seattle, WA. For additional information and to sign up for email alerts and
get RSS feeds, please visit

Forward-Looking Statements

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 market price of CTI's
securities. Specifically, the risks and uncertainties that could affect the
development of PIXUVRI include risks associated with preclinical and clinical
developments in the biopharmaceutical industry in general and with PIXUVRI in
particular including, without limitation, that CTI may not obtain
reimbursement in certain markets in the E.U. as planned; that results in
future studies of PIXUVRI may differ from the results of past studies; that
the G-BA's decision regarding PIXUVRI may not be made in the second quarter of
2013; that the G-BA may not determine that PIXUVRI provides an additional
benefit; that the G-BA's decision may have an impact on the reimbursement of
PIXUVRI in Germany; that CTI may not be able to complete the PIX306 clinical
trial of PIXUVRI-rituximab compared to gemcitabine-rituximab in patients who
have relapsed after 1 to 3 prior regimens for aggressive B-cellNHL and who
are not eligible for autologous stem cell transplant byJune 2015or at all as
required by the EMA or have the results of such trial available byJune
2015or at all; that CTI may not be able complete a post-marketing study aimed
at confirming the clinical benefit observed in the PIX301 trial; that the
conditional marketing authorization for PIXUVRI may not be renewed; that CTI
cannot predict or guarantee the pace or geography of enrollment of its
clinical trials or the total number of patients enrolled; that CTI's average
net operating burn rate may increase; CTI's may not be able to continue to
raise capital as needed to fund its operations in general, and other risks,
including, without limitation, competitive factors, technological
developments, costs of developing, producing, and selling PIXUVRI, and the
risk factors listed or described from time to time in CTI's filings with
theSecurities and Exchange Commissionincluding, 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.

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

1. European Cancer Observatory, Cancer Fact Sheets, 2008
2. Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
3. Friedberg ASH Education Book 2011;1:498-505


Monique Greer
+1 206-272-4343

Ed Bell
+1 206.282.7100

SOURCE Cell Therapeutics, Inc.

Press spacebar to pause and continue. Press esc to stop.