SAN FRANCISCO, April 2, 2015 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) announced today that it has received a
$100 million payment under a license
agreement with AstraZeneca. The cash payment under the
Nektar-AstraZeneca agreement was triggered by the first commercial
sale of MOVANTIK (naloxegol) in the U.S. MOVANTIK is 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.
"We're pleased that MOVANTIK is now available as an important
treatment option for the millions of patients suffering from
opioid-induced constipation," said Howard
W. Robin, President and Chief Executive Officer of
Nektar. "This significant milestone for MOVANTIK showcases
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."
MOVANTIK was developed using Nektar's oral small molecule
polymer conjugate technology. 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
$100 million milestone payment
announced today, Nektar is entitled to a $40
million milestone payment upon first commercial sale of
MOVANTIK in a major European country, as well as 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® 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, BAX 855, a longer-acting PEGylated Factor VIII
therapeutic is in Phase 3 development conducted by partner
Baxter. A BLA for BAX 855 was
filed by Baxter to the US FDA in
December, 2014 and is currently under review. 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 of the AstraZeneca group of
companies.
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 (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, 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) 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. Other important risks and uncertainties set forth
in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission on February 26,
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
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SOURCE Nektar Therapeutics