Nektar Completes Enrollment in Phase 3 BEACON Study of Etirinotecan Pegol in Women With Metastatic Breast Cancer

 Nektar Completes Enrollment in Phase 3 BEACON Study of Etirinotecan Pegol in
                     Women With Metastatic Breast Cancer

-Recruitment Completed Five Months Ahead of Schedule-

PR Newswire

SAN FRANCISCO, July 30, 2013

SAN FRANCISCO, July 30, 2013 /PRNewswire/-- Nektar Therapeutics (NASDAQ:NKTR)
today announced that enrollment is complete in the pivotal clinical study of
etirinotecan pegol (NKTR-102) in patients with metastatic breast cancer. The
Phase 3 study, also known as the BEACON trial, is evaluating etirinotecan
pegol versus a single-agent treatment of physician's choice for the treatment
of locally recurrent or metastatic breast cancer. Etirinotecan pegol is the
first long-acting topoisomerase I inhibitor designed to concentrate in tumor
tissue to provide sustained tumor suppression throughout the entire
chemotherapy cycle.

"Strong interest in etirinotecan pegol and the BEACON study from investigators
and patients has allowed us to rapidly complete our recruitment and
enrollment," said Robert Medve, MD, Senior Vice President and Chief Medical
Officer of Nektar Therapeutics. "We recognize the high unmet need for new
treatment options in the metastatic breast cancer setting, particularly among
patients with HER2-negative breast cancer whose disease has progressed
following anthracycline, taxane and capecitabine therapies.The primary
endpoint in the BEACON study is survival and as we have previously announced,
we plan to conduct an interim futility analysis for the BEACON study in the
first quarter of next year with topline survival data to be available around
the end of 2014."

Positive Phase 2 data for etirinotecan pegol was previously announced and
presented at the ASCO 2011 Breast Cancer Symposium (Garcia et. al., ASCO
2011). Etirinotecan pegol achieved a confirmed objective response rate by
RECIST of 29 percent. In addition, 71 percent of patients in the study had no
tumor progression, defined as complete response (CR), partial response (PR)
and stable disease (SD), as measured by RECIST criteria. Etirinotecan pegol
also demonstrated a high clinical benefit rate (CR+PR+SD greater than six
months) of 46 percent (30 of 66). Six patients experienced 100 percent
resolution of all target lesions, with two complete RECIST responses and four
near-complete responses.Patients treated exhibited minimal alopecia,
neuropathy and neutropenia, which are significant adverse events associated
with existing breast cancer therapies. Side effects were generally manageable;
the most common Grade 3 toxicity was diarrhea (17-23%) typically occurring
after three months of therapy for both schedules.

About the BEACON Study

BEACON is a Phase 3, open-label, randomized, multicenter study of etirinotecan
pegol in approximately 840 women with locally recurrent or metastatic breast
cancer, who have previously been treated with anthracycline, taxane or
capecitabine (ATC) treatments. The trial is being conducted at approximately
150 sites worldwide including North America, Eastern and Western Europe, and
certain countries in Asia/Pacific. Patients were randomized on a 1:1 basis to
receive 145 mg/m2 of single-agent etirinotecan pegol once every three weeks or
a single agent of physician's choice. The physician's choice agents include:
ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane. Randomization
was stratified by geographic region, prior use of eribulin and receptor
status.

The primary endpoint of the BEACON study is overall survival, and secondary
endpoints include progression-free survival, objective tumor response rates
(ORR), clinical benefit rate, duration of response, PK data, safety profiles,
quality-of-life measurements, and pharmacoeconomic implications. The study is
also evaluating specific biomarker data to assess correlation with objective
tumor response rates, progression-free survival, overall survival and selected
toxicities.

About Etirinotecan Pegol (NKTR-102)

As a new long-acting topoisomerase I inhibitor, etirinotecan pegol has a
non-overlapping mechanism of action with other agents used to treat breast
cancer which may mitigate potential cancer cross-resistance and reduce
overlapping toxicities. In November 2012, etirinotecan pegol was designated a
Fast Track development program by the U.S. FDA for the treatment of patients
with locally recurrent or metastatic breast cancer progressing after treatment
with an anthracycline, a taxane, and capecitabine (ATC).

Etirinotecan pegol is believed to penetrate the vasculature of the tumor
environment more readily than normal vasculature, increasing the concentration
of active drug within tumor tissue to enhance anti-tumor activity. In addition
to metastatic breast cancer, etirinotecan pegol is also being evaluated for
the treatment of ovarian, colorectal, glioma and non-small cell lung cancers.

About Metastatic Breast Cancer

More than one million women worldwide are diagnosed with breast cancer
globally every year(1). The chance of developing invasive breast cancer at
some time in a woman's life is a little less than one in eight (12%). There
are approximately 200,000 new cases of breast cancer in the United States and
430,000 in Europe each year.(2) Metastatic breast cancer refers to cancer that
has spread from the breast to distant sites in the body.

Anthracyclines and taxanes (AT) are the most active and widely used
chemotherapeutic agents for breast cancer, but the increased use of these
agents at an early stage of disease often renders tumors resistant to these
drugs by the time the disease recurs, thereby reducing the number of treatment
options for metastatic disease. Drugs used to treat patients who progress
following AT treatment can have response rates as high as 20-30%; however,
resistance develops rapidly and new agents with different mechanisms of
action, such as topoisomerase I inhibitors, are needed to allow novel ways to
overcome the problem of drug resistance.(3) ^ There are currently no
FDA-approved topoisomerase I inhibitors to treat breast cancer.

About Nektar
Nektar Therapeutics is a biopharmaceutical company developing novel
therapeutics based on its PEGylation and advanced polymer conjugation
technology platforms. Nektar has a robust R&D pipeline of potentially
high-value therapeutics in oncology, pain and other therapeutic areas. In the
area of pain, Nektar has an exclusive worldwide license agreement with
AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which
has completed Phase 3 development as a once- daily, oral tablet for the
treatment of opioid-induced constipation. This agreement also includes
NKTR-119, an earlier stage development program that is a co-formulation of
naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for
chronic pain conditions, is in Phase 2 development in osteoarthritis patients
with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development
to treat acute pain is in Phase 1 clinical development. In anti-infectives,
Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an
adjunctive treatment for intubated and mechanically ventilated patients with
Gram-negative pneumonia.

Nektar's technology has enabled eight approved products in the U.S. or Europe
through partnerships with leading biopharmaceutical companies, including UCB's
Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for
hepatitis C and Amgen's Neulasta® for neutropenia. Additional
development-stage products that leverage Nektar's proprietary technology
platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program,
which is in Phase 3 clinical development.

Nektar is headquartered in San Francisco, California, with additional
operations in Huntsville, Alabama and Hyderabad, India. Further information
about the company and its drug development programs and capabilities may be
found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: "anticipate," "intend," "plan,"
"expect," "believe," "should," "may," "will" and similar references to future
periods. Examples of forward-looking statements include, among others,
statements we make regarding the therapeutic potential of etirinotecan pegol
for women with locally recurring or metastatic breast cancer, the predictive
potential of prospectively measured biomarkers in the BEACON study to
potentially identify patients more likely to benefit from etirinotecan pegol,
the projected percentage of patients participating in the CTC sub-set of the
BEACON clinical study, the projected timeframe in which we expect the BEACON
clinical study to be fully enrolled, and the value and potential of our
technology and drug candidates in our research and development pipeline.
Forward-looking statements are neither historical facts nor assurances of
future performance. Instead, they are based only on our current beliefs,
expectations and assumptions regarding the future of our business, future
plans and strategies, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the future,
they are subject to inherent uncertainties, risks and changes in circumstances
that are difficult to predict and many of which are outside of our control.
Our actual results may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause our actual
results to differ materially from those indicated in the forward-looking
statements include, among others, (i) the prospectively measured biomarkers
have not previously been linked to more positive clinical outcomes for
metastatic breast cancer patients receiving etirinotecan pegol therapy; (ii)
etirinotecan pegol is in clinical development and the risk of failure is high
and can unexpectedly occur at any time prior to regulatory approval for
numerous reasons including safety and efficacy findings in the BEACON study;
(iii) the statements regarding the therapeutic potential of etirinotecan pegol
are based on preclinical data and data from the completed Phase 2 clinical
study and the future results from the BEACON clinical study may not confirm
these earlier findings; (iv) our drug candidates and those of our
collaboration partners are in various stages of clinical development and the
risk of failure is high and can unexpectedly occur at any stage prior to
regulatory approval for numerous reasons including safety and efficacy
findings even after positive findings in previous preclinical and clinical
studies; (v) the timing of the commencement or end of clinical trials and the
commercial launch of our drug candidates may be delayed or unsuccessful due to
regulatory delays, slower than anticipated patient enrollment, manufacturing
challenges, changing standards of care, evolving regulatory requirements,
clinical trial design, clinical outcomes, competitive factors, or delay or
failure in ultimately obtaining regulatory approval in one or more important
markets; and (vi) certain other important risks and uncertainties set forth in
our Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission on May 9, 2013. Any forward-looking statement made by us in this
press release is based only on information currently available to us and
speaks only as of the date on which it is made. We undertake no obligation to
update any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information, future
developments or otherwise.

Nektar Investor and Media Inquiries:
Jennifer Ruddock/Nektar Therapeutics       (415) 482-5585
Susan Noonan/SA Noonan Communications, LLC (212) 966-3650

(1) American Cancer Society, 2007 Global Cancer Facts and Figures Report.

(2) American Cancer Society, 2009 Global Cancer Facts and Figures Report.

(3) Moreno-Aspitia and Perez, Mayo Clin Proc. 2009; 84(6):533-545

SOURCE Nektar Therapeutics

Website: http://www.nektar.com
 
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