CTI BioPharma Expands Access To PIXUVRI® With Approval In Israel And Add-on Reimbursement Status In The Netherlands

 CTI BioPharma Expands Access To PIXUVRI® With Approval In Israel And Add-on
                   Reimbursement Status In The Netherlands

PR Newswire

SEATTLE, July 21, 2014

SEATTLE, July 21, 2014 /PRNewswire/ -- CTI BioPharma Corp. (CTI) (NASDAQ and
MTA: CTIC) announced today that it has received approval from the Israeli
Ministry of Health (MOH) for PIXUVRI^® (pixantrone).

PIXUVRI in Israel is indicated as monotherapy for the treatment of adult
patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin
lymphoma (aggressive B-cell NHL) who have received not more than three
previous courses of treatment. The benefit of pixantrone treatment has not
been established in patients when used as fifth line or greater chemotherapy
in patients who are refractory to last therapy.

In Israel, PIXUVRI will be distributed and marketed by the Neopharm Group,
Israel's second largest pharmaceuticals and health products marketer, once
PIXUVRI is included in the Israeli National Health Basket of drugs by the MOH.

"The approval of PIXUVRI in Israel provides patients with aggressive B-cell
NHL who have failed second- or third-line therapy a new approved option, where
none existed before, that can effectively treat their disease with manageable
side effects," said Abraham Avigdor, M.D., Faculty of Medicine at Tel Aviv
University, Ramat Aviv, Israel and Division of Hematology and Bone Marrow
Transplantation, Chaim Sheba Medical Center, Tel-Hashomer, Israel. "Patients
who have relapsed after second-line therapy have a poor survival outcome. It
is vital to have additional treatment options available, like PIXUVRI, so we
can provide these patients the best care possible and help them battle their
disease."

"We are pleased to continue to expand the availability of PIXUVRI as interest
in this new therapy continues to grow," said James A. Bianco, M.D., President
and Chief Executive Officer of CTI. "We feel PIXUVRI fills an important role
in the treatment paradigm for patients with aggressive B-cell NHL, and we are
focused on increasing access to the treatment for as many patients as
possible."

Separately, the Dutch Healthcare Authority (NZa) and the healthcare insurance
board College voor zorgverzekeringen (CVZ) of the Netherlands have approved
funding for PIXUVRI as an add-on drug for patients who need a third- or
fourth-line treatment option for aggressive B-cell lymphoma. This follows the
inclusion of PIXUVRI on the HOVON (Haemato Oncology Foundation for Adults in
the Netherlands) treatment guidelines, effective June 1, 2014. The inclusion
on the Dutch list of reimbursed drugs makes PIXUVRI the first registered and
reimbursed medicine for the treatment of patients with multiply relapsed or
refractory aggressive B-cell NHL in the Netherlands.

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.

In May 2012, the European Commission granted conditional marketing
authorization for PIXUVRI as a monotherapy for the treatment of adult patients
with relapsed or refractory aggressive B-cell NHL. 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. The SmPC is available at www.pixuvri.eu. PIXUVRI does not
have marketing approval in the United States.

About NHL

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.^1 After initial therapy for
aggressive NHL with anthracycline-based combination therapy, one-third of
patients typically develop progressive disease.^2 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.^2
For those patients who fail to respond or relapse following second-line
treatment, treatment options are limited, and usually palliative only.^2

About Conditional Marketing Authorization

Similar to accelerated approval regulations in the United States, conditional
marketing authorizations are granted in the E.U. to medicinal products with a
positive benefit/risk assessment that 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 Committee for Medicinal Products for Human Use
has 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‑cell NHL
and 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 by June 2015.

About CTI BioPharma

CTI BioPharma Corp. (NASDAQ and MTA: CTIC) is a biopharmaceutical company
focused on the acquisition, development and commercialization of novel
targeted therapies covering a spectrum of blood-related cancers that offer a
unique benefit to patients and healthcare providers. CTI has a commercial
presence in Europe and a late-stage development pipeline, including
pacritinib, CTI's lead product candidate that is currently being studied in a
Phase 3 program for the treatment of patients with myelofibrosis. CTI is
headquartered in Seattle, Washington, with offices in London and Milan under
the name CTI Life Sciences Limited. For additional information and to sign up
for email alerts and get RSS feeds, please visit www.ctibiopharma.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 CTI's expectations with respect
to the development of CTI and its product and product candidate portfolio, the
expected distribution and marketing of PIXUVRI by the Neopharm Group, the
reimbursement status of PIXUVRI in Israel and the expected benefits and
effectiveness of PIXUVRI. 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 E.U. as planned, that the
conditional marketing authorization for PIXUVRI may not be renewed, 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 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 CTI BioPharma Corp.

References

1.Harris NL, et al. The World Health Organization Classification of
    Neoplastic Diseases of the Hematopoietic and Lymphoid Tissues. Report of
    the Clinical Advisory Committee Meeting, Airlie House, Virginia, November,
    1997. Ann Oncol. 1999 Dec;10(12):1419-32
2.Friedberg JW. Relapsed/Refractory Diffuse Large B-Cell Lymphoma.
    Hematology Am Soc Hematol Educ Program. 2011;2011:498-505. doi:
    10.1182/asheducation-2011.1.498.

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

Ed Bell
+1 206-282-7100
ebell@ctibiopharma.com 

In Europe: CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 94751572
lvilla@cti-lifesciences.com



SOURCE CTI BioPharma Corp.

Website: http://www.ctibiopharma.com
 
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