SAN FRANCISCO, June 11, 2014 /PRNewswire/ -- Nektar Therapeutics
(NASDAQ:NKTR), a biopharmaceutical company developing novel pain
and cancer therapeutics, today announced that NASDAQ has halted
trading of the company's common stock.
The U.S. Food and Drug Administration's (FDA) Anesthetic and
Analgesic Drug Products Advisory Committee (AADPAC) is meeting on
June 11-12, 2014 to discuss potential
cardiovascular risk associated with peripherally-acting opioid
receptor antagonists which includes MOVANTIKTM
(naloxegol oxalate), an investigational treatment for
opioid-induced constipation (OIC). The AADPAC will consider
the necessity, timing, design and size of cardiovascular outcomes
trials to support approval of products in the class for the
proposed indication of opioid-induced constipation in patients
taking opioids for chronic pain.
The AADPAC meeting is scheduled for 8:00
a.m. ET. The briefing materials can be found on the FDA
website at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm.
MOVANTIK is being developed by Nektar partner AstraZeneca.
The Prescription Drug User Fee Act (PDUFA) date set by the FDA for
MOVANTIK is September 16, 2014.
MOVANTIK is also under regulatory review with health agencies in
the European Union and Canada.
The FDA is not required to follow the guidance of an advisory
committee when rendering its final decisions on pending
applications and other public health matters.
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 regulatory events 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 outcome of the ADAAP
advisory committee meeting and the
subsequent 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, (ii) 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; (iii) 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; (iv) 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; (v) 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
(vi) 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