SAN FRANCISCO, Sept. 26, 2014 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) reported today that partner AstraZeneca
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending approval of MOVENTIG® (naloxegol) for
the treatment of opioid-induced constipation (OIC) in adult
patients who have had an inadequate response to laxatives. MOVENTIG
is an investigational, peripherally-acting mu-opioid receptor
antagonist (PAMORA).
OIC is a condition caused by prescription opioid pain medicines.
Opioids 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.
The positive opinion was reached after a review of comprehensive
data from the KODIAC clinical program, which was comprised of four
studies assessing the safety and efficacy of MOVENTIG.
The CHMP's positive opinion on MOVENTIG will be reviewed by the
European Commission (EC), which has the authority to approve
medicines for the European Union. The final decision will be
applicable to all 28 European Union member countries plus
Iceland and Norway. Should the EC approve MOVENTIG, it
will be the first once-daily, oral PAMORA available in these
markets for the treatment of OIC in adult patients who have had an
inadequate response to laxatives.
Today's announcement follows the approval on September 16, 2014, of MOVANTIK™ (naloxegol)
tablets by the U.S. Food and Drug Administration (FDA) as the first
once-daily PAMORA for the treatment of OIC in adult patients with
chronic non-cancer pain.
About MOVENTIG® (naloxegol)
MOVENTIG is an
investigational PAMORA specifically designed for the treatment of
OIC in adult patients on prescription opioid pain medicines. In
Phase III clinical studies, MOVENTIG 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.
The KODIAC clinical program was comprised of KODIAC-4, -5, -7
and -8. KODIAC-4 and -5 were identically-designed,
placebo-controlled, double-blind, 12-week studies assessing safety
and efficacy. KODIAC-7 was a 12-week safety extension to KODIAC-4,
and KODIAC-8 was a 52-week long-term safety study.
MOVENTIG is part of the exclusive worldwide licence agreement
announced on September 21, 2009,
between AstraZeneca and Nektar Therapeutics. MOVENTIG 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
MOVANTIKTM, the first FDA-approved 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. The AstraZeneca
agreement also includes NKTR-119, an earlier stage development
program that is a co-formulation of MOVANTIK and an opioid.
NKTR-181, a wholly-owned mu-opioid analgesic molecule for chronic
pain conditions, has completed Phase 2 development. NKTR-171, a
wholly-owned 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. In
hemophilia, BAX 855, a longer-acting PEGylated Factor VIII
therapeutic is in Phase 3 development conducted by partner
Baxter. 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.
Nektar's technology has enabled nine approved products in the
U.S. or Europe through
partnerships with leading biopharmaceutical companies, including
AstraZeneca's MOVANTIK, 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 MOVENTIG 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) although the CHMP has issued a
positive opinion on MOVENTIG, the approval of MOVENTIG remains
subject to the review and discretion of the European
Commission; (ii) the commercial launch of
MOVANTIKTM and MOVENTIG are
subject to the completion of the U.S. Drug Enforcement
Agency's (DEA) determination that
MOVANTIKTM is an unscheduled drug under the
United States 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; (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 MOVANTIK
and MOVENTIG, 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 MOVANTIK and
MOVENTIG; 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