NICE Publishes Final Guidance on PIXUVRI® (pixantrone)

            NICE Publishes Final Guidance on PIXUVRI® (pixantrone)

- Published Final Guidance Recommending PIXUVRI as Cost Effective and Provides
Patients with Aggressive B-cell Non-Hodgkin Lymphoma (NHL) Greater Access to
Only Approved Therapy -

PR Newswire

SEATTLE, Feb. 27, 2014

SEATTLE, Feb. 27, 2014 /PRNewswire/ --Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today reported that the National Institute for Health and Care
Excellence (NICE), the independent body responsible for driving improvement
and excellence in the health and social care system in the UK, has published
final guidance recommending prescription of PIXUVRI^® (pixantrone) as a
cost-effective monotherapy for the treatment of adult patients with multiply
relapsed or refractory aggressiveB-cell non-Hodgkin lymphoma (aggressive
B-cell NHL), which includes diffuse large B-cell lymphoma. CTI estimates that
there are approximately 1,600 to 1,800 people in the UK diagnosed with
multiply relapsed aggressive B-cell NHL per year.

"NICE's final guidance on PIXUVRI means that physicians in England and Wales
now have access to the only approved therapy for their patients with
aggressive B-cell NHL in the third- and fourth-line salvage setting," James A.
Bianco, M.D., President and Chief Executive Officer of CTI. "We hope the NHS
commissioners will recognize the lack of suitable treatment options that exist
for patients at this stage of the disease and list PIXUVRI on hospital
formularies as soon as possible."

The final guidance determines PIXUVRI cost effective and recommends
prescription of PIXUVRI as an option for certain people with histologically
confirmed aggressive B-cell NHL, who have previously received rituximab and
are receiving PIXUVRI as a third- or fourth-line treatment, for as long as CTI
makes the Patient Access Scheme (PAS) available. The PAS is a confidential
pricing and access agreement with the United Kingdom's Department of Health.

Publication of the final guidance by NICE follows the final appraisal
determination, or FAD, that was issued in January 2014. Now that the final
guidance is published, the NHS is expected to implement it within 90 days. CTI
expects to officially launch PIXUVRI in England and Wales this spring, after
the FAD has been largely implemented. For more information on NICE's final
guidance, go to www.pixuvri.eu.

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. PIXUVRI does not
have marketing approval inthe United States.

About NHL
NHL is the sixth most common cancer in the UK; in 2010, 12,180 people were
diagnosed with the disease.^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 55 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'sCommittee 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 within the meaning of
the Safe Harbor provisions of the Private Securities Litigation Reform Act of
1995. Such statements are subject to a number of risks and uncertainties, the
outcome of which could materially and/or adversely affect actual future
results and the trading price of CTI's securities. Such statements include,
but are not limited to, statements regarding the expected number of people in
the UK with multiply relapsed aggressive B-cell NHL per year, expectations
with respect to the development of CTI and its product and product candidate
portfolio, the expected benefits and effectiveness of PIXUVRI, NHS' processes,
pricing arrangements and the cost-effectiveness and availability of PIXUVRI to
patients in the United Kingdom. Risks that contribute to the uncertain nature
of the forward-looking statements include, among others, risks associated with
the biopharmaceutical industry in general and with CTI and its product and
product candidate portfolio in particular including, among others, risks
associated with the following: that CTI cannot predict or guarantee the pace
or geography of enrollment of its clinical trials, that CTI cannot predict or
guarantee the outcome of preclinical and clinical studies, that CTI may not
obtain reimbursement for PIXUVRI in certain markets in the European Union as
planned, that the conditional marketing authorization for PIXUVRI may not be
renewed, that the second Phase 3 clinical trial of pacritinib will not occur
as planned, that CTI may not obtain favorable determinations by other
regulatory, patent and administrative governmental authorities, that CTI may
experience delays in the commencement of preclinical and clinical studies,
risks related to the costs of developing, producing and selling PIXUVRI,
pacritinib, and CTI's other product candidates, and other risks, including,
without limitation, competitive factors, technological developments, that
CTI's operating expenses continue to exceed its net revenues, that CTI may not
be able to sustain its current cost controls or further reduce its operating
expenses, that CTI may not achieve previously announced goals and objectives
as or when projected, that CTI's average net operating burn rate may increase,
that CTI will continue to need to raise capital to fund its operating
expenses, but may not be able to raise sufficient amounts to fund its
continued operation as well as other risks listed or described from time to
time in CTI's most recent filings with the Securities and Exchange Commission
on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to
update any of the statements in this press release upon further developments.

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

References:

1. Cancer Research UK
http://www.cancerresearchuk.org/cancer-info/cancerstats/incidence/commoncancers/Accessed
April 2013.
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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