Market Access Granted in Italy for Aggressive non-Hodgkin Lymphoma Treatment, PIXUVRI® (pixantrone)

Market Access Granted in Italy for Aggressive non-Hodgkin Lymphoma Treatment,
                            PIXUVRI® (pixantrone)

PR Newswire

SEATTLE, July 8, 2013

SEATTLE, July 8, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today announced that the Company has been granted market access
by the Italian Medicines Agency (AIFA) for the medicinal product PIXUVRI^®
(pixantrone) as a monotherapy for the treatment of adult patients with
multiply relapsed or refractory aggressiveB-cell non-Hodgkin lymphoma
(patients with aggressive B-cell NHL who failed 2 or 3 prior lines of
therapy). Pixantrone has been classified by AIFA for use in hospitals and
additional details on the pricing and reimbursement conditions for PIXUVRI in
Italy will be provided coincident with the publication of the "Determina" of
AIFA in the Official Gazette, which is expected to take 6 to 8 weeks.

In May 2012, the European Commission (EC) granted conditional marketing
authorization in the European Union (E.U.) for PIXUVRI as a monotherapy for
adult patients with multiply relapsed or refractory aggressive B-cell NHL
based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3
clinical trial. PIXUVRI was made available to patients in eight countries in
the European Union in the fourth quarter of 2012, and some patients in other
countries have already started to receive the treatment. Prior to the
approval of PIXUVRI in the E.U., there were no approved agents or standard of
care in this disease. The PIX301 trial was designed utilizing agents in the
comparator arm that have anti-tumor activity in relapsed disease and are
typically employed as palliative therapy for these patients.

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 atwww.pixuvri.eu.

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

According to the Italian Association of Cancer Registries (AIRTUM), in 2012
approximately 12,700 people were diagnosed with NHL in Italy.^1 NHL is caused
by the abnormal proliferation of lymphocytes, cells that are 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 www.CellTherapeutics.com.

Forward-Looking Statements

This press release includes forward-looking statements that are made pursuant
to the Safe Harbor provisions of the Private Securities Litigation Reform Act
of 1995, including, but not limited to, statements regarding the Company's
intentions and expectations regarding AIFA's processes, pricing arrangements,
timing of the release of additional details concerning pricing and
reimbursement conditions and the development of PIXUVRI and the Company in
general. Such statements 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 these matters 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 European Union as
planned; 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 clinical 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 results in future studies of PIXUVRI may differ from the results of past
studies; 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; that CTI 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.

References:
1. AIRTUM (Italian Association of Cancer Registries) 2012
2. Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
3. Friedberg, ASH Education Book 2011;1:498-505

Contacts: Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com

Ed Bell
+1 206.282.7100
ebell@ctiseattle.com

In Europe

CTI Life Sciences Limited, Milan Branch
Laura Villa
E: lvilla@cti-lifesciences.com
T: +39 02 89659706
http://www.celltherapeutics.com/italiano

SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com
 
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