SAN FRANCISCO, Sept. 16, 2014 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) reported today that partner AstraZeneca
today announced that the US Food and Drug Administration (FDA)
approved MOVANTIK™ (naloxegol) tablets as
the first once-daily oral peripherally-acting mu-opioid receptor
antagonist (PAMORA) medication for the treatment of opioid-induced
constipation (OIC), in adult patients with chronic, non-cancer
pain.
Opioids play an important role in chronic pain relief and
millions of patients are treated with them in the United States each year. They work by
binding to mu-receptors in the central nervous system, but they
also bind to mu-receptors in the gastrointestinal tract, which can
result in patients suffering from OIC.
"As the first once-daily oral PAMORA approved in the U.S.,
MOVANTIK provides a new treatment option for a common and
potentially debilitating side effect experienced by adult patients
treated with opioids," said Howard W.
Robin, President and CEO of Nektar Therapeutics. "Further,
the approval of MOVANTIK represents a significant milestone in
Nektar's evolution as it is the first oral small molecule medicine
to be created with our proprietary polymer chemistry
platform."
The FDA approval of MOVANTIK was based on data from the KODIAC
clinical programme, which is comprised of four studies: KODIAC-4,
-5, -7 and -8. KODIAC-4 and -5 were both placebo controlled,
double-blind, 12 week studies assessing safety and efficacy, while
KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8
was a 52 week open label, long-term safety study.
In line with the recommendation from the FDA Anesthetic and
Analgesic Drug Products Advisory Committee (AADPAC) that took place
in June 2014, AstraZeneca has agreed
to conduct a post-marketing, observational epidemiologic
cardiovascular safety study for MOVANTIK.
MOVANTIK is expected to be available to patients in the first
half of 2015. MOVANTIK is currently a schedule II controlled
substance because it is structurally related to noroxymorphone.
During the review of the New Drug Application, the FDA evaluated
the abuse potential of MOVANTIK and the approved labelling
indicates that MOVANTIK has no risk of abuse or dependency.
AstraZeneca submitted a petition for the descheduling of MOVANTIK
to the US Drug Enforcement Administration (DEA) in March 2012, which was accepted for review and
will be considered by the DEA as part of the process for addressing
the descheduling request.
Results from KODIAC-4 and -5 were published in the
New England Journal of Medicine on 19
June 2014. Naloxegol is also under regulatory review by the
European Medicines Agency (EMA).
About MOVANTIK™ (naloxegol) tablets C-II
MOVANTIK™ (naloxegol) is the first FDA approved once-daily
peripherally-acting mu-opioid receptor antagonist (PAMORA)
specifically designed for the treatment of opioid-induced
constipation (OIC) in adult patients with chronic non-cancer pain.
In the Phase III clinical studies, MOVANTIK was administered as a
once-daily tablet and was designed to block the binding of opioids
to opioid receptors in tissues such as the gastrointestinal (GI)
tract.
MOVANTIK is part of the exclusive worldwide licence agreement
announced on 21 September 2009
between AstraZeneca and Nektar Therapeutics. MOVANTIK was developed
using Nektar's oral small molecule polymer conjugate
technology.
About Nektar
Nektar Therapeutics has a robust R&D pipeline of potentially
high-value therapeutics in pain, oncology, hemophilia and other
therapeutic areas. In the area of pain, Nektar has an exclusive
worldwide license agreement with AstraZeneca for MOVANTIK. This
agreement also includes NKTR-119, an earlier stage development
program that is a co-formulation of MOVANTIK 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-171, a new sodium channel
blocker being developed as an oral therapy for the treatment of
peripheral neuropathic 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, colorectal, lung and brain cancers. 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.
Additional late-stage development candidates that leverage Nektar's
proprietary technology platform include Baxter's BAX 855, a longer-acting PEGylated
rFVIII therapeutic, which is in Phase 3 clinical development for
patients with hemophilia A.
Nektar's technology has enabled nine 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.
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 potential of MOVANTIKTM
(naloxegol oxalate) and the value and potential of our technology
and 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 commercial
launch of MOVANTIKTM is subject to the
completion of the U.S. Drug Enforcement Agency's determination that
MOVANTIKTM is an unscheduled drug under the
Controlled Substances Act pursuant to a decontrol petition
submitted by AstraZeneca in March
2012 and there is no prescribed timeframe for the DEA to
complete its review of the decontrol; (ii) a
marketing application for MOVANTIKTM remains under
review by the European Medicines Agency, (iii)
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; (iv) 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; (v) acceptance, review
and approval decisions for new drug applications by health
authorities is an uncertain and evolving process and health
authorities retain significant discretion at all stages of the
regulatory review and approval decision process; (vi)
patents may not issue from our patent applications for
MOVANTIKTM, patents that have issued may not be
enforceable, or additional intellectual property licenses from
third parties may be required; and (vii) the outcome
of any existing or future intellectual property or other litigation
related to our proprietary drug candidates or those of our
collaboration partners including MOVANTIKTM; and
(viii) 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 1, 2014. 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.
Contact:
INVESTORS
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
MEDIA:
Nadia Hasan of WCG Group
212-257-6738
SOURCE Nektar Therapeutics