UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
report (Date of earliest event reported): September 20, 2009
NEKTAR
THERAPEUTICS
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
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0-24006
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94-3134940
|
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
201
Industrial Road
San
Carlos, California 94070
(Address
of Principal Executive Offices and Zip Code)
Registrant’s
telephone number, including area code: (650) 631-3100
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
1.01. Entry into a Material Definitive
Agreement
On
September 20, 2009, Nektar Therapeutics, a Delaware corporation (“Nektar”),
entered into a License Agreement (the “Agreement”) with AstraZeneca AB, a
Swedish corporation (“AstraZeneca”). The Agreement is subject to
review by the U. S. Government under the Hart-Scott-Rodino Act (the “HSR Act”)
and will not become effective until the expiration or earlier termination of the
waiting period (or any extension thereof). Either party may terminate
the Agreement 120 days after the date of filing under the HSR Act, if the
transaction is not effective by that date.
Under the
terms of the Agreement, Nektar and AstraZeneca agree to cooperate in researching
and developing products derived from the application of Nektar’s proprietary
product candidates Oral NKTR-118 (PEGylated naloxol), a peripheral opioid
antagonist in clinical development for the treatment of opioid-induced
constipation (OIC) and other manifestations of opioid bowel dysfunction (OBD),
and the Oral NKTR-119 program which combines Oral NKTR-118 with certain opioid
compounds. Pursuant to the Agreement, Nektar granted AstraZeneca a
worldwide exclusive license to NKTR-118 and NKTR-119.
Under the
terms of the Agreement, AstraZeneca agreed to pay Nektar an up-front payment of
$125 million. In relation to NKTR-118, AstraZeneca will use
commercially reasonable efforts to develop NKTR-118 and Nektar is eligible to
receive up to $235 million in development milestones and up to $375 million in
additional sales milestones if the product achieves certain commercial sales
levels. In relation to NKTR-119, AstraZeneca will use commercially
reasonable efforts to develop one product based on NKTR-119 and has rights to
develop multiple products based on NKTR-119. For each of the first
two initial products based on NKTR-119, Nektar is eligible to receive for each
of such products up to $75 million in development milestones and up to $310
million in additional sales milestones. For both NKTR-118 and
NKTR-119, Nektar is also eligible to receive significant and escalating
double-digit royalty payments, varying by country of sale and based on annual
net sales. Nektar’s right to receive royalties (subject to certain
adjustments) in any particular country will expire upon the later of (a)
specified period of time after the first commercial sale of the product in that
country (or in the European Union if the country is in the European Union) or
(b) the expiration of patent rights in that particular country.
On an
interim basis, Nektar will supply AstraZeneca with its requirements for NKTR-118
clinical study material on a cost plus basis, until a technology transfer
enabling AstraZeneca to undertake such manufacture is
completed. AstraZeneca is responsible for all other clinical
manufacturing and all commercial manufacturing. Nektar will grant
AstraZeneca a worldwide, exclusive, perpetual, royalty-bearing, sublicensable
license under Nektar’s patents and know-how to develop, sell and otherwise
exploit NKTR-118 and NKTR-119. AstraZeneca will bear all costs
associated with research, development and commercialization and will control
product development and commercialization decisions. Each party
retains rights to its own intellectual property and an equal, undivided interest
in jointly-developed intellectual property in connection with the work conducted
under or in connection with the Agreement.
Pursuant
to the terms of the Agreement, each of Nektar and AstraZeneca agrees, for a
period of five years from the first commercial sale of a product in the United
States or two other specified markets, not to conduct late stage development of,
or commercialize, certain competing products for the prevention, treatment or
amelioration of opioid-induced constipation or opioid-induced bowel
dysfunction. The Agreement includes various representations,
warranties, covenants, indemnities and other provisions customary for
transactions of this nature. AstraZeneca may terminate the Agreement
(i) for certain specified safety, efficacy or regulatory reasons, and (ii) on a
country by country basis, in the event of certain intellectual property
infringement events. Either party may terminate the Agreement in the
event of an uncured material breach.
The
foregoing summary is qualified in its entirety by reference to the Agreement,
which will be filed as an exhibit to Nektar’s Quarterly Report on Form 10-Q for
the period ended September 30, 2009.
Item
7.01. Regulation FD Disclosure
On
September 21, 2009, Nektar issued a press release announcing entry into the
Agreement, which is filed herewith as Exhibit 99.1 to this Current
Report. The information in this Item 7.01, including
Exhibit 99.1, is being furnished and shall not be deemed filed for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liability of that section, nor
shall such information be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933,
as amended, or the Exchange Act, except as otherwise stated in such
filing.
Nektar
will host a conference call at 8:30 a.m. Eastern time / 5:30 a.m. Pacific time
on September 21, 2009, to update stockholders on the Agreement and the
collaboration with AstraZeneca announced today. Callers may join the
call via telephone at 866.543.6403 (domestic) or 617.213.8896
(international). The participant passcode is
72093106. Access to the live webcast will be available via the
Investor Relations section of the Company’s Website at
www.nektar.com. A replay will also be available within 24 hours for
at least seven days following the conference call.
FORWARD
LOOKING STATEMENTS
In this
Form 8-K Nektar makes, and on the conference call referred to above management
expects to make, certain forward-looking statements regarding the collaboration
with AstraZeneca. These forward-looking statements involve
substantial risks and uncertainties including but not limited to: (i) laboratory
research and clinical trials are long, expensive and uncertain processes and the
successful completion of future development milestones will be required in order
for Nektar to realize future development milestone payments under the Agreement,
(ii) the risk of failure of any product that is in pre-clinical and clinical
development and prior to regulatory approval is high and can occur at any stage
due to efficacy, safety or other factors, (iii) any failure would likely result
in reduced or no further payments to Nektar from AstraZeneca, (iv) competing
alternative therapies that are currently on the market or under development
could reduce the commercial potential of the products which could materially
reduce Nektar’s royalty revenue and sales milestones under the Agreement, (v)
the Agreement could be terminated under customary conditions, (vi) AstraZeneca
and Nektar may not be successful in obtaining regulatory approval of the
products, (vii) the products may not achieve a minimally acceptable commercial
profile based on results of clinical trials or competing therapies that target
one or more of the same indications, (viii) Nektar’s patent applications for the
products which have not already issued may not issue, or even if such patents
issue, the claims contained in such pending patents and patents that have
already been issued to Nektar may not provide sufficient market exclusivity,
(ix) current patents and future patents that may issue may not be valid or
enforceable and (x) potential future third-party intellectual property
disputes. Other important risks and uncertainties are detailed in
Nektar’s reports and other filings with the SEC including its most recent Annual
Report on Form 10-K and Quarterly Report on Form 10-Q. Actual results
could differ materially from the forward-looking statements. Nektar
undertakes no obligation to update forward-looking statements, whether as a
result of new information, future events or otherwise.
(d)
Exhibits
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Exhibit Number
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Description
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99.1
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Press
Release issued on September 21, 2009 by Nektar Therapeutics announcing
collaboration with AstraZeneca for development of NKTR-118 and
NKTR-119.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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Nektar
Therapeutics
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||
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Date:
September 21, 2009
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By:
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/s/ Gil M. Labrucherie
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Gil
M. Labrucherie
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General
Counsel and Secretary
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EXHIBIT
INDEX
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Exhibit Number
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Description
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99.1
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Press
Release issued on September 21, 2009 by Nektar Therapeutics announcing
collaboration with AstraZeneca for development of NKTR-118 and
NKTR-119.
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Exhibit
99.1
 |
 |
News
Release
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, CA —
September 21, 2009 — 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).
-ENDS-
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®, Roche's PEGASYS®
for hepatitis C and Amgen's Neulasta® 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.
# #
#
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Nektar
Investor Enquiries:
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Jennifer
Ruddock/Nektar Therapeutics
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+1
650-631-4954
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Susan
Noonan/SAN Group
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(212)
966-3650
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Nektar
Media Enquiries:
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Karen
Bergman/BCC Partners
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(650)
323-1717
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AZ
Media Enquiries:
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Neil
McCrae
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+44
20 7304 5045 (24 hours)
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Chris
Sampson
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+44
20 7304 5130 (24 hours)
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Sarah
Lindgreen
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+44
20 7304 5033 (24 hours)
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Emily
Denney
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+1
302 885 3451
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AZ
Investor Enquiries UK:
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||
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Jonathan
Hunt
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+44
207 304 5087
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mob:
+44 7775 704032
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Karl
Hard
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+44
207 304 5322
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mob:
+44 7789 654364
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AZ
Investor Enquiries US:
|
||
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Ed
Seage
|
+1
302 886 4065
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mob:
+1 302 373 1361
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Jorgen
Winroth
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+1
212 579 0506
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mob:
+1 917 612 4043
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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