SAN FRANCISCO, Sept. 1, 2015 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) announced today that it has received
a $40 million cash payment under a license agreement with
AstraZeneca. The payment was triggered by the first commercial sale
of MOVENTIG (naloxegol) in Germany. MOVENTIG is the first once-daily,
oral peripherally-acting mu-opioid receptor antagonist (PAMORA)
medication approved in the European Union for the treatment of
opioid-induced constipation (OIC) in adult patients who have had an
inadequate response to laxative(s). MOVENTIG is marketed
in the U.S. by AstraZeneca as MOVANTIK™ (naloxegol) and is the
first once-daily oral PAMORA medication indicated for the
treatment of OIC in adult patients with chronic, non-cancer
pain.
"We're pleased that MOVENTIG is now available in Europe as an important treatment option for
the millions of patients suffering from OIC," said Howard W.
Robin, President and Chief Executive Officer of Nektar. "This
significant commercial milestone for MOVENTIG
highlights Nektar's invention and development of a
first-in-class oral medicine that is specifically designed to
target the common and potentially debilitating condition
experienced by chronic pain patients treated with opioids."
MOVENTIG/MOVANTIK is part of the exclusive worldwide license
agreement announced on September 21, 2009 between
AstraZeneca and Nektar Therapeutics. Under the terms of the
agreement, in addition to the $40 million milestone
payment announced today, Nektar received a $100
million milestone payment upon first commercial sale of
MOVANTIK in the U.S. in March of 2015. Nektar is also entitled to
royalties on worldwide net product sales and up to $375
million in sales milestones. The royalty rate in the
U.S. starts at 20% and escalates. The royalty rate
in Europe and the rest of the world starts at 18% and
escalates. Under the agreement, AstraZeneca is responsible
for all sales and marketing activities for MOVANTIK worldwide.
About Nektar
Nektar Therapeutics has a robust R&D pipeline in pain,
oncology, hemophilia and other therapeutic areas. In the area of
pain, Nektar has an exclusive worldwide license agreement
with AstraZeneca for MOVANTIK™ (naloxegol), 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 product is also approved in
the European Union as MOVENTIG® (naloxegol) and is
indicated for adult patients with OIC who have had an inadequate
response to laxatives. 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, is in
Phase 3 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
hemophilia, ADYNOVATE™ [Antihemophilic Factor (Recombinant)], a
longer-acting PEGylated Factor VIII therapeutic has been filed for
approval in the U.S. by partner Baxalta Inc. 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.
MOVANTIK™ is a trademark and MOVENTIG® is a registered trademark
of the AstraZeneca group of companies.
ADYNOVATE is a trademark of Baxalta Inc.
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
MOVANTIK/MOVENTIG (naloxegol) and the value and potential of
our polymer conjugate 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 potential of a new drug at
the early stages of commercial launch, such as MOVANTIK/MOVENTIG,
is difficult to predict and will have a significant impact on our
future results of operation and financial condition; (ii)
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; (iii) patents may not issue from
our patent applications for our drugs (including MOVANTIK/MOVENTIG)
and drug candidates, patents that have issued may not be
enforceable, or additional intellectual property licenses from
third parties may be required; and (iv) the outcome of any existing
or future intellectual property or other litigation related to our
drugs and drug candidates and those of our collaboration partners
including MOVANTIK/MOVENTIG. Other important risks and
uncertainties set forth in our Annual Report on Form 10-Q filed
with the Securities and Exchange
Commission on August 6, 2015. 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
212-257-6738
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nektar-announces-receipt-of-40-million-milestone-payment-resulting-from-first-commercial-sale-of-moventig-naloxegol-tablets-in-major-european-market-300135765.html
SOURCE Nektar Therapeutics