Nektar Reports that Partner AstraZeneca Announced European Medicines Agency Acceptance of Marketing Authorisation Application

 Nektar Reports that Partner AstraZeneca Announced European Medicines Agency
       Acceptance of Marketing Authorisation Application for Naloxegol

PR Newswire

SAN FRANCISCO, Sept. 30, 2013

SAN FRANCISCO, Sept. 30, 2013 /PRNewswire/ --Nektar Therapeutics
(NASDAQ:NKTR) reported today that AstraZeneca announced that the European
Medicines Agency (EMA) has accepted the Marketing Authorisation Application
(MAA) for Naloxegol, an investigational peripherally-acting mu-opioid receptor
antagonist, which has been specifically designed for the treatment of
opioid-induced constipation (OIC) for adult patients 18 years and older,
including patients with inadequate response to laxatives.

The MAA filing was based on comprehensive data from the core Phase III KODIAC
programme, 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, randomised, double blind, placebo-controlled pivotal trials
evaluated 12.5 mg and 25 mg doses of naloxegol, administered once-daily.
KODIAC-07 was a 12-week safety extension of KODIAC-04, and KODIAC-08 (n= 534)
was an open-label, randomised, 52-week, long-term safety trial.

Naloxegol has the potential to be the first once-daily oral
peripherally-acting mu-opioid receptor antagonist medication for patients with
OIC. 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 recently amended License Agreement, AstraZeneca will pay Nektar a $25
million milestone within five business days of acceptance of the MAA by the


About Opioid-Induced Constipation
OIC is a condition caused by prescription opioid pain medicines. 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 is a result of increased fluid absorption and
lower GI motility due to opioid receptor binding in the gastrointestinal
tract. ^

Globally, approximately 40–50% (28-35 million) of patients taking opioids for
long-term pain develop opioid-induced constipation. 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 program that is a co-formulation of
naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for
chronic pain conditions, has completed 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 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

SOURCE Nektar Therapeutics

Contact: Jennifer Ruddock, 650-283-6253
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