AstraZeneca and Nektar Sign Worldwide Agreement for Nektar Drug Development Programmes...
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AstraZeneca and Nektar Sign Worldwide Agreement for Nektar Drug Development
Programmes -- NKTR-118 and NKTR-119 -- to Address Opioid-Induced Constipation
LONDON and SAN CARLOS, Calif., Sept. 21 /PRNewswire-FirstCall/ -- AstraZeneca
and Nektar Therapeutics announced today that they have entered into an
exclusive worldwide license agreement for two drug development programmes:
NKTR-118, a late stage investigational product being evaluated for the
treatment of opioid-induced constipation, and the NKTR-119 programme, an early
stage programme that is intended to deliver products for the treatment of pain
without constipation side effects. Both programmes were developed by Nektar,
utilizing their proprietary small molecule advanced polymer conjugate
technology platform.
Under the terms of the agreement, AstraZeneca will assume the responsibility
for the continued development of both the NKTR-118 and NKTR-119 programmes,
including the initiation of late-stage clinical studies for NKTR-118.
AstraZeneca expects completion of the design of the phase III programme in the
near term, and anticipates filing the drug with regulators in 2013.
AstraZeneca will also be responsible for global manufacturing and marketing
for both programmes. Under the agreement, Nektar will receive an upfront
payment of $125 million for both NKTR-118 and NKTR-119.
NKTR-118 has completed a Phase 2 clinical trial and is being developed to
treat constipation caused by the use of opioid pain products. Under the
agreement, for NKTR-118, Nektar is eligible to receive up to $235 million in
aggregate payments upon the achievement of certain regulatory milestones, as
well as additional tiered sales milestone payments of up to $375 million if
the product achieves considerable levels of commercial success. Nektar will
also be eligible to receive significant double-digit royalty payments on net
sales of NKTR-118 worldwide.
NKTR-119 is an early stage drug development programme that is intended to
combine oral NKTR-118 with selected opioids, with the goal of treating pain
without the side effect of constipation traditionally associated with opioid
therapy. AstraZeneca will continue the development of this programme,
including determining the appropriate opioid combinations with NKTR-118. For
NKTR-119, Nektar would receive development milestone payments as well as
tiered sales milestone payments. Nektar will also receive significant
double-digit royalty payments on NKTR-119 net sales worldwide.
"NKTR-118 is an important late stage programme that has the potential to
address a real need for patients," said David Brennan, Chief Executive Officer
of AstraZeneca. "We are excited about this agreement with Nektar, as it
provides us the opportunity to apply our deep knowledge and expertise in
neuroscience, oncology and gastrointestinal areas of medicine to create real
value for patients. This is a good example of using externalisation to enrich
the company's late-stage pipeline."
"We are extremely pleased to enter into this exclusive global license
agreement with AstraZeneca," said Howard W. Robin, President and Chief
Executive Officer of Nektar Therapeutics. "AstraZeneca has a strong history of
creating and establishing market-leading brands, which makes them the ideal
development and commercial partner for our NKTR-118 and NKTR-119 programmes.
In addition to the promise that these potential products provide to patients,
this partnership validates Nektar's successful strategy to create novel oral
small molecule drug candidates with our advanced polymer conjugate technology
platform."
NKTR-118 is an investigational drug candidate that combines Nektar's advanced
small molecule polymer conjugate technology platform with naloxol, a
derivative of the opioid-antagonist drug, naloxone. Results from NKTR-118's
Phase 2 clinical trial will be presented at an oral plenary session of the
American College of Gastroenterology 2009 Annual Scientific Meeting in
October.
The agreement is subject to review by the United States Government under the
Hart-Scott Rodino Act and becomes effective after the expiration or earlier
termination of the waiting period (or any extension thereof).
NOTES TO EDITORS:
About Opioid Induced Constipation
It is estimated that for those patients who take opiates chronically for pain
management, anywhere from 40-90% of such patients will develop constipation.
Less than half of those patients find effective relief from current treatment
options that include prescription and over-the-counter laxatives and stool
softeners. These symptoms of bowel dysfunction are a result of the drug
binding to the mu-opioid receptor in the gut(1). Opioid-induced bowel
dysfunction encompasses symptoms such as constipation, bloating, abdominal
cramping, and gastroesophageal reflux. Constipation is the hallmark of this
syndrome and is generally its most prominent component.
According to IMS Health, about 230 million prescriptions were written for
opioids in 2007 in the United States alone. This is estimated to represent
about 65-75% of the worldwide opioid market. Currently, there are no oral
drugs approved that are indicated to treat opioid-induced constipation.
Opioid bowel dysfunction and opioid-induced constipation can significantly
impact quality of life and increase healthcare utilisation.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful prescription
medicines and supplier for healthcare services. AstraZeneca is one of the
world's leading pharmaceutical companies with healthcare sales of US$ 31.6
billion and is a leader in gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infectious disease medicines. For more information
about AstraZeneca, please visit: www.astrazeneca.com
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing novel
therapeutics based on its PEGylation and advanced polymer conjugation
technology platforms. Nektar's technology and drug development expertise have
enabled nine approved products in the U.S. or Europe for partners, which
include leading biopharmaceutical companies, including UCB's Cimzia(R),
Roche's PEGASYS(R) for hepatitis C and Amgen's Neulasta(R) for neutropenia.
Nektar has created a robust pipeline of potentially high-value therapeutics to
address unmet medical needs by leveraging and expanding its technology
platforms to improve and enable molecules. Nektar is currently conducting
clinical and preclinical programmes in oncology, pain and other therapeutic
areas. NKTR-102, PEGylated irinotecan, is currently in Phase 2 clinical
studies in ovarian, breast and colorectal cancer. NKTR-105, PEGylated
docetaxel, is currently in a Phase 1 clinical study in patients with
refractory solid tumors.
Nektar is headquartered in San Carlos, California, with additional R&D
operations in Huntsville, Alabama and Hyderabad, India. Further information
about the company and its drug development programmes and capabilities may be
found online at http://www.nektar.com.
Nektar Investor Enquiries:
Jennifer Ruddock/Nektar Therapeutics +1 650-631-4954
Susan Noonan/SAN Group (212) 966-3650
Nektar Media Enquiries:
Karen Bergman/BCC Partners (650) 575-1509
Michelle Corral/BCC Partners (415) 794-8662
AZ Media Enquiries:
Neil McCrae +44 20 7304 5045 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Sarah Lindgreen +44 20 7304 5033 (24 hours)
Emily Denney +1 302 885 3451
AZ Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Karl Hard +44 207 304 5322 mob: +44 7789 654364
AZ Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043
(1.) Panchal SJ, Muller-Schwefe P, Wurzelmann JI. Opioid-induced bowel
dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract.
2007;61(7):1181-1187
SOURCE Nektar Therapeutics
Nektar Investor Enquiries: Jennifer Ruddock of Nektar Therapeutics,
+1-650-631-4954; Susan Noonan of SAN Group, +1-212-966-3650; Nektar Media
Enquiries: Karen Bergman, +1-650-575-1509, or Michelle Corral,
+1-415-794-8662, both of BCC Partners; AZ Media Enquiries: Neil McCrae, +44 20
7304 5045 (24 hours), Chris Sampson, +44 20 7304 5130 (24 hours), Sarah
Lindgreen, +44 20 7304 5033 (24 hours), or Emily Denney, +1-302-885-3451, AZ
Investor Enquiries UK: Jonathan Hunt, +44 207 304 5087, mob: +44 7775 704032,
or Karl Hard, +44 207 304 5322, mob: +44 7789 654364, or AZ Investor Enquiries
US: Ed Seage, +1-302-886 4065, mob: +1-302-373-1361, or Jorgen Winroth,
+1-212-579-0506, mob: +1-917-612-4043
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