Nektar and Roswell Park Cancer Institute Announce Initiation of Investigator-Sponsored Trial Evaluating Etirinotecan Pegol (NKTR

       Nektar and Roswell Park Cancer Institute Announce Initiation of
  Investigator-Sponsored Trial Evaluating Etirinotecan Pegol (NKTR-102) as a
Second-Line Treatment in Patients with Relapsed or Refractory Small Cell Lung
                                Cancer (SCLC)

PR Newswire

SAN FRANCISCO and BUFFALO, N.Y., Oct. 24, 2013

SAN FRANCISCO and BUFFALO, N.Y., Oct. 24, 2013 /PRNewswire/ --Nektar
Therapeutics (NASDAQ:NKTR) and Roswell Park Cancer Institute (RPCI) announced
today that the first patients have been dosed in a phase II
investigator-sponsored study of etirinotecan pegol in patients with relapsed
or refractory Small-Cell Lung Cancer (SCLC). The study is being conducted at
Roswell Park under the direction of Alex Adjei, M.D., Ph.D., F.A.C.P., Senior
Vice President for Clinical Research and Chair of the Department of Medicine
at RPCI.

Etirinotecan pegol is the first long-acting topoisomerase-I inhibitor that
concentrates in tumor tissue and provides sustained tumor suppression
throughout the entire chemotherapy cycle.

"For patients with relapsed small-cell lung cancer, prognosis is poor with
second-line therapy," said Dr. Adjei. "Approved topoisomerase-I inhibitors
have demonstrated anti-tumor activity in small-cell lung cancer, but their use
is often hampered by significant toxicity and pharmacokinetics. Given this
background, we are very interested in evaluating etirinotecan pegol as a
potential treatment option for this patient population."

The primary endpoint of the phase II study is the 18-week progression-free
survival (PFS) rate. Secondary endpoints include objective response rate
(ORR), overall survival (OS), median duration of response (DoR) and the safety
profile of etirinotecan pegol in patients with relapsed SCLC. This
single-stage study will evaluate etirinotecan pegol in two patient cohorts:
chemo-resistant (those progressing within three months after completing
first-line therapy) and chemo-sensitive (those progressing at three months or
later after completing first-line therapy). The study is expected to enroll
approximately 38 patients who will receive etirinotecan pegol once every three
weeks as monotherapy.

"We are very pleased that Dr. Adjei has identified and proposed this study of
single-agent etirinotecan pegol in this difficult to treat patient
population," said Robert Medve, M.D., Senior Vice President and Chief Medical
Officer of Nektar Therapeutics. "This is the third phase II
investigator-sponsored trial evaluating etirinotecan pegol and demonstrates
our continued commitment to fully understanding etirinotecan pegol's potential
in resistant or refractory cancers where there are limited treatment options."

About SCLC

Small-cell lung cancer (SCLC) is one of the most aggressive and lethal cancers
in humans. It accounts for 15-20% of all lung cancer. Although standard
combination cytotoxic chemotherapy agents have shown antitumor activity with
initial responses of 70%–90% for both limited and extensive stages of SCLC,
long-term survival is low and most patients eventually develop progressive
disease within the first 2 years.^1-3 Consequently, there is a need for new
therapies that are safe and effective, which also improve overall survival and
quality of life.

About Etirinotecan Pegol

Etirinotecan pegol is a unique, targeted topoisomerase-I inhibitor designed
for prolonged tumor cell exposure. 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
antitumor activity.The BEACON study is a Phase 3 clinical study currently
evaluating etirinotecan pegol for the treatment of locally recurrent or
metastatic breast cancer. In addition to metastatic breast cancer,
etirinotecan pegol is also being evaluated for the treatment of ovarian,
colorectal, high-grade glioma and non-small-cell lung cancers.

About Roswell Park Cancer Institute

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent
and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in
the country to be named a National Cancer Institute-designated comprehensive
cancer center and remains the only facility with this designation in Upstate
New York. The Institute is a member of the prestigious National Comprehensive
Cancer Network, an alliance of the nation's leading cancer centers; maintains
affiliate sites; and is a partner in national and international collaborative
programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI
(1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on
Facebook and Twitter.

About Nektar

Nektar Therapeutics (NASDAQ: NKTR) 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. For naloxegol, an MAA has been
accepted for filing in Europe, and an NDA has been submitted for filing in the
U.S. 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 molecule for chronic pain conditions, has completed Phase
2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a
novel mu-opioid analgesic molecule 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 a number of Phase 2
studies. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted
by Bayer Healthcare to treat 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," "could," "potential," "may" and similar
references to future periods. Examples of forward-looking statements include
our current views regarding etirinotecan pegol as a potential new therapy for
cancer patients; the value of our advanced 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 still 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 from the
ongoing BEACON Phase 3 clinical study; (ii) the statements regarding the
therapeutic potential of etirinotecan pegol are based on preclinical data and
data from completed Phase 2 clinical studies and future clinical study results
may not confirm these earlier findings; (iii) the timing of the commencement
or end of clinical trials, target timeframe for the availability of clinical
results, and the successful commercial launch of our drug candidates may be
delayed or unsuccessful due to 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; (vi) the
outcome of any existing or future intellectual property or other litigation
related to our proprietary drug candidates; and (vii) certain other important
risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on August 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 Inquiries:
Jennifer Ruddock/Nektar Therapeutics                (415) 482-5585
Susan Noonan/SA Noonan Communications, LLC          (212) 966-3650
Roswell Park Media Inquiries:                       (716) 845-5747
Tara Yates, Director of Public Affairs              tara.yates@roswellpark.org
Nektar Media Inquiries: 

Marisa Borgasano/MSL                                (781) 684-0770
Brianne Cannon /MSL                                 (415) 817-2545
nektar@schwartzmsl.com

References

1.Jett JR, Everson L, Therneau TM, et al., Treatment of limited-stage
    small-cell lung cancer with cyclophosphamide, doxorubicin, and vincristine
    with or without etoposide: a randomized trial of the North Central Cancer
    Treatment Group. J Clin Oncol. 1990 Jan;8(1):33-8.
2.Livingston RB, et al., Small-cell carcinoma of the lung: combined
    chemotherapy and radiation: a Southwest Oncology Group study. Ann Intern
    Med. 1978 Feb;88(2):194-9.
3.Maksymiuk, AW, et al., Sequencing and schedule effects of cisplatin plus
    etoposide in small-cell lung cancer: results of a North Central Cancer
    Treatment Group randomized clinical trial. J Clin Oncol. 1994
    Jan;12(1):70-6.

SOURCE Nektar Therapeutics

Website: http://www.nektar.com
 
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