Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast

Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol
           (NKTR-102) for the Treatment of Metastatic Breast Cancer

PR Newswire

SAN FRANCISCO, Nov. 7, 2012

SAN FRANCISCO, Nov. 7, 2012 /PRNewswire/ --Nektar Therapeutics (NASDAQ:NKTR)
announced today that the U.S. Food and Drug Administration (FDA) has
designated etirinotecan pegol (NKTR-102) as a Fast Track development program
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 a unique, targeted topoisomerase I
inhibitor designed using Nektar's proprietary polymer conjugate technology.
The drug candidate is currently being evaluated in a Phase 3 study in women
with metastatic breast cancer.

"We are very pleased that the etirinotecan pegol development program in breast
cancer has been granted Fast Track designation and we look forward to
continuing to work closely with the FDA on this program," said Robert Medve,
MD, Chief Medical Officer of Nektar Therapeutics."Patients with advanced
breast cancer who have progressed following ATC therapies have limited
treatment options to manage their disease.As a novel targeted topoisomerase I
inhibitor, etirinotecan pegol is a different mechanism of action than
currently approved therapies and has the potential to deliver improved
efficacy while offering a more tolerable therapy for women with this
aggressive disease."

Nektar requested Fast Track designation from the FDA for etirinotecan pegol
based upon what is known about its safety and efficacy profile to-date from
the nonclinical, Phase 1 and Phase 2 clinical studies, as well as etirinotecan
pegol's potential to deliver better efficacy and a more tolerable therapy for
patients with locally recurrent or metastatic breast cancer progressing after
treatment with ATC. Etirinotecan pegol, a new topoisomerase I inhibitor, was
designed to improve the efficacy of irinotecan by modifying the distribution
of the drug candidate within the body.As a new 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.

Under the FDA Modernization Act of 1997, the Fast Track program facilitates
interactions with the FDA before and during the submission of a New Drug
Application (NDA) for therapeutics being investigated as a treatment for
serious or life-threatening conditions, which demonstrate the potential to
address an unmet medical need for such conditions. The Fast Track program
enables a company to file sections of an NDA on a rolling basis as data
becomes available. This permits the FDA to review portions of the NDA as they
are received, rather than waiting for the entire NDA filing prior to
commencing the review process. With a Fast Track designation, there is the
possibility of a priority review and a more opportunity for more frequent
interactions with the FDA, which could decrease the typical development time
and review period.

About the Phase 3 BEACON Study of Etirinotecan Pegol

The BEACON Study (BrEAst Cancer Outcomes with NKTR-102) will enroll
approximately 840 metastatic breast cancer patients who have had prior
treatment with ATC in either the adjuvant or metastatic setting.The primary
endpoint of the BEACON study is overall survival (OS). Secondary endpoints
include progression-free survival (PFS), objective tumor response rates (ORR),
clinical benefit rate, duration of response, pharmacokinetic (PK) data,
safety, quality-of-life measurements, and measurement of healthcare resource
utilization for the two study arms.Exploratory objectives of the study
include collecting specific biomarker data which will be correlated with
efficacy outcome measures.Enrollment in the BEACON study began in December
2011 and is expected to be completed by the end of 2013.

About Metastatic Breast Cancer

More than one million people 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 of 20-30%; however, resistance
develops rapidly and new agents with different mechanisms of action, such as
topoisomerase I inhibitors, are needed that have the potential to overcome the
problem of drug resistance to prior therapies. (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
is being evaluated in Phase 3 clinical studies 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 oncology, etirinotecan pegol (NKTR-102) is being evaluated in
a Phase 3 clinical study (the BEACON study) for the treatment of metastatic
breast cancer and is also in Phase 2 studies for the treatment of ovarian and
colorectal cancers.

Nektar's technology has enabled eight approved products in the U.S. or Europe
through partnerships with leading biopharmaceutical companies, including
Affymax's OMONTYS® for anemia, 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 has completed Phase 1/2 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

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," "could," "potential," "may" and similar
references to future periods. Examples of forward-looking statements include
our current views as to the potential of etirinotecan pegol as a potential new
therapy for patients with metastatic breast cancer; the expected enrollment
completion date for the BEACON trial; the value of our polymer conjugate
technology platform; and the potential of certain of our other drug candidates
and those of our collaboration partners. Forward-looking statements are
neither historical facts nor assurances of future performance. Instead, they
are based only on our current beliefs, expectations, observations and
assumptions regarding the potential of our drug candidates and our technology.
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) 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; (ii) 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; (iii) the timing of the commencement or end of clinical trials and
the successful commercial launch of our drug candidates may be delayed or
unsuccessful due to slower than anticipated patient enrollment, manufacturing
challenges, changing standards of care, regulatory delay, 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; (iv) scientific discovery of new medical breakthroughs is
an inherently uncertain process and the future success of the application of
our technology platform to potential new drug candidates such as etirinotecan
pegol is therefore very uncertain and unpredictable and could unexpectedly
fail at any time; (v) patents may not issue from our patent applications for
etirinotecan pegol, patents that have issued may not be enforceable, or
additional intellectual property licenses from third parties may be required;
and (vi) the outcome of any existing or future intellectual property or other
litigation related to our proprietary drug candidates. Other important risks
and uncertainties are detailed in our reports and other filings with the
Securities and Exchange Commission ("SEC"), including without limitation,
those risks and uncertainties set forth in our quarterly report on Form 10-Q
for the quarter ended June 30, 2012, filed with the SEC on August 9, 2012. 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 Inquiries:
Jennifer Ruddock/Nektar Therapeutics       (415) 482-5585
Susan Noonan/SA Noonan Communications, LLC (212) 966-3650

Nektar Media Inquiries:
Mary Cunney (917) 208-2162
Mike Huckman    (646) 500-7631

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

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

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

SOURCE Nektar Therapeutics

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