SAN FRANCISCO, June 12, 2014 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) reported today that partner AstraZeneca
announced that the majority of US Food and Drug Administration
(FDA) Anesthetic and Analgesic Drug Products Advisory Committee
(AADPAC) members voted that the FDA should not require
cardiovascular outcomes trials for the peripherally-acting
mu-opioid receptor antagonist (PAMORA) class of drugs, which
includes MOVANTIKTM (naloxegol oxalate), an
investigational treatment for opioid-induced constipation (OIC) for
patients with chronic non-cancer pain. Following a clarification of
the vote, the majority of the Committee suggested continued
post-approval data collection for cardiovascular safety.
The FDA convened a meeting of the AADPAC to review the class of
peripherally acting opioid receptor antagonists on June 11-12, 2014. The meeting assessed the
necessity, timing, design and size of cardiovascular outcomes
trials to support approval of products in the class, for the
proposed indication of OIC in patients taking opioids for chronic
non-cancer pain. The FDA is not bound by the Advisory Committee's
recommendation, but takes its advice into consideration when
reviewing applications for investigational medicines. The
Prescription Drug User Fee Act (PDUFA) date set by the FDA for
MOVANTIK is September 16, 2014.
"We are exceptionally pleased that the Committee did not find it
necessary to require a cardiovascular outcomes trial," said
Howard W. Robin, President and CEO
of Nektar Therapeutics. "We look forward to the FDA's continued
review of the New Drug Application for MOVANTIK and the potential
for MOVANTIK to become the first once-daily, oral PAMORA for the
treatment of OIC for patients with chronic non-cancer pain."
MOVANTIK was designed using Nektar's proprietary oral, small
molecule polymer conjugate technology. MOVANTIK is part of
the exclusive worldwide licence agreement announced in September 2009 between AstraZeneca and
Nektar.
Opioids play an important role in chronic pain relief by binding
mu-receptors in the brain, but they also bind mu-receptors in the
bowel. That is why patients taking opioids for chronic pain can
develop OIC. In fact, the incidence of OIC can be as high as 81% in
patients taking opioids. There is a significant unmet need for
safe, effective treatment options for patients with OIC. An
estimated 235 million prescriptions for opioids are written in the
US each year, of which 20% are for chronic pain. For patients
taking prescription opioids for chronic pain, constipation is one
of the most common side effects and one not adequately relieved by
laxatives.
In addition to the U.S., AstraZeneca has also submitted
regulatory filings for MOVANTIK with health agencies in the
European Union and Canada.
On June 4, 2014, the New England
Journal of Medicine published data online from two pivotal Phase
III studies of MOVANTIK, KODIAC-4 and KODIAC-5. Both studies met
their primary endpoint, showing an improvement in treatment effect
versus placebo. Results from these studies show that more OIC
non-cancer pain patients treated with MOVANTIK at a 25 mg dose had
a consistent response of increased spontaneous bowel movements
through 12 weeks of treatment compared to placebo.
About MOVANTIKTM (naloxegol oxalate)
MOVANTIK is an investigational peripherally-acting mu-opioid
receptor antagonist (PAMORA) specifically designed for the
treatment of opioid-induced constipation (OIC) in patients with
chronic non-cancer pain. In the Phase III clinical studies,
MOVANTIK was administered as a once-daily tablet and is designed to
block the binding of opioids to the opioid receptors in the
gastrointestinal (GI) tract without impacting the opioid receptors
in the brain.
About Opioid-Induced Constipation (OIC)
Opioids play an important role in chronic pain relief by binding
mu-receptors in the brain. But they also bind mu-receptors in the
bowel. That is why patients taking opioids for chronic pain can
develop opioid-induced constipation (OIC). In fact, the incidence
of OIC varies and has been reported as high as 81% in patients
taking opioids.
About Nektar
Nektar Therapeutics has a robust R&D pipeline of potentially
high-value therapeutics in pain, oncology and other therapeutic
areas. In the area of pain, Nektar has an exclusive worldwide
license agreement with AstraZeneca for MOVANTIK, an investigational
drug candidate, which has been filed for regulatory approvals in
the U.S., Europe and Canada 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 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 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.
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 regulatory process and outcomes
for 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 voting and recommendations from
the AADPAC areadvisory only and not binding on the
FDA; (ii) upcoming FDA determinations made in the
MOVANTIKTM new drug application review process will have
a significant impact on the Company's financial position based on
significant regulatory and launch milestone opportunities and a
potential repayment obligation by the Company to AstraZeneca as
described in our most recent Quarterly Report on Form 10-Q filed
with the SEC on May 8, 2014 (the
"Form 10-Q") and the Current Report on Form 8-K filed with the SEC
on August 8, 2013;
(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) 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 is therefore highly uncertain and
unpredictable and one or more research and development programs
could fail; and (vii) certain other important risks
and uncertainties set forth in our Form 10-Q. 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:
Nektar Therapeutics
Jennifer Ruddock
650-283-6253
SOURCE Nektar Therapeutics