New Drug Application For Naloxegol Accepted By United States Food And Drug Administration

  New Drug Application For Naloxegol Accepted By United States Food And Drug
                                Administration

PR Newswire

SAN FRANCISCO, Nov. 19, 2013

SAN FRANCISCO, Nov. 19, 2013 /PRNewswire/ --Nektar Therapeutics (NASDAQ:NKTR)
reported today that partner AstraZeneca announced that the United States Food
and Drug Administration (FDA) has accepted the New Drug Application (NDA) for
naloxegol, an investigational peripherally-acting mu-opioid receptor
antagonist (PAMORA), which has been studied in opioid-induced constipation
(OIC) in adult patients with chronic non-cancer pain, the most common side
effect ^ caused by chronic administration of prescription opioid pain
medicines.

The NDA filing was based on comprehensive data from the core Phase III KODIAC
programme, which is comprised of four clinical trials designed to investigate
the safety and efficacy of naloxegol for the treatment of OIC. Two pivotal
Phase III studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week,
multicentre, randomized, double blind, placebo-controlled pivotal trials
evaluated 12.5 mg and 25 mg doses of naloxegol, administered once-daily.
KODIAC-07, a 12-week safety extension of KODIAC-04, and KODIAC-08 (n= 534) was
an open-label controlled, randomized, 52-week, long-term safety trial.

Naloxegol has the potential to be the first once-daily oral PAMORA for
patients with OIC in the United States. Naloxegol was developed using Nektar's
oral small molecule polymer conjugate technology.

Naloxegol is part of the exclusive worldwide license agreement announced on 21
September 2009, between AstraZeneca and Nektar Therapeutics. Under the terms
of the amended license agreement, AstraZeneca will make a $70 million
milestone payment to Nektar within five business days of acceptance of the NDA
by the FDA.

About Naloxegol

Naloxegol is an investigational peripherally-acting mu-opioid receptor
antagonist (PAMORA), which has been specifically designed for the treatment of
opioid-induced constipation (OIC), a condition caused by prescription opioid
pain medicines. Naloxegol is a once-daily tablet designed to block the binding
of opioids to the opioid receptors in the gastrointestinal (GI) tract without
impacting the opioid receptors in the brain.

Naloxegol is part of the exclusive worldwide license agreement announced on 21
September 2009, between AstraZeneca and Nektar Therapeutics. Naloxegol was
developed using Nektar's oral small molecule polymer conjugate technology.

About Opioid-Induced Constipation

Opioids bind to specific proteins called opioid receptors. When the opioids
bind to certain opioid receptors in the gastrointestinal (GI) tract,
constipation may occur. Opioid-induced constipation (OIC) is a result of
increased fluid absorption and lower GI motility due to opioid receptor
binding in the GI tract.

Globally, approximately 40–50% (28-35 million) of patients taking opioids for
long-term pain develop OIC. About 40–50% (11-18 million) of those OIC
sufferers achieve the desired treatment outcomes with current options that
include over-the-counter and prescription laxatives.

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. This agreement also includes
NKTR-119, an earlier stage development programme 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. 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 programme,
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 programmes and capabilities may be
found online at http://www.nektar.com

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

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SOURCE Nektar Therapeutics

Website: http://www.nektar.com