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): April 9, 2008
NEKTAR
THERAPEUTICS
(Exact
name of Registrant as specified in its charter)
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Delaware
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0-24006
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94-3134940
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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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:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
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Item 8.01
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Other
Events.
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On
April
9, 2008, Nektar Therapeutics issued the press release which is filed herewith
as Exhibit 99.1 to the report.
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Item 9.01
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Financial
Statements and Exhibits
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Item
No.
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Description
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99.1
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Press
Release titled “Nektar Terminates All Negotiations with Potential Partners
for Inhaled Insulin: Increased Number of Lung Cancer Cases Observed
in
Ongoing Clinical Studies of Inhaled Insulin
Patients.”
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SIGNATURES
Pursuant
to the requirement 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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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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Date:
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April
9, 2008
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Nektar
Terminates All Negotiations with Potential Partners for Inhaled Insulin;
Increased
Number of Lung Cancer Cases Observed in Ongoing
Clinical
Studies of Inhaled Insulin Patients
San
Carlos, CA, April 9, 2008 - Nektar
Therapeutics (Nasdaq: NKTR) announced today that it has ceased all negotiations
with potential partners for its inhaled insulin programs as a result of new
data
analysis from ongoing clinical trials conducted by Pfizer Inc. An increase
in
the number of new cases of lung cancer was observed in inhaled insulin patients
as compared to the control group. All new incidences of lung cancer were in
patients that are former smokers.
“The
concern over this new data analysis from ongoing clinical trials has resulted
in
the termination of all negotiations with potential partners,” said Howard W.
Robin, President and CEO of Nektar. “Fortunately, over the past year Nektar has
significantly transformed its business, moving away from inhaled insulin. We
have made great progress expanding our research efforts and have built a deep
pipeline of novel partnered and proprietary drugs in various stages of
development.”
Nektar
will cease all spending associated
with its inhaled insulin programs and will not incur any additional charges
related to this event.
The
Exubera label was updated by Pfizer to contain the following safety information
warning:
“In
clinical trials of Exubera, there have been 6 newly diagnosed cases of primary
lung malignancies among Exubera-treated patients, and 1 newly diagnosed case
among comparator treated patients. There has also been 1 post-marketing report
of a primary lung malignancy in an Exubera-treated patient. In controlled
clinical trials of Exubera, the incidence of new primary lung cancer per 100
patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years)
for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for
comparator-treated patients. There were too few cases to determine whether
the
emergence of these events is related to Exubera. All patients who were diagnosed
with lung cancer had a prior history of cigarette smoking.”
About
Nektar
Nektar
Therapeutics is a biopharmaceutical company that develops and enables
differentiated therapeutics with its industry-leading PEGylation and pulmonary
drug development platforms. Nektar PEGylation and pulmonary technology,
expertise, manufacturing capabilities have enabled ten approved products for
partners, which include the world’s leading pharmaceutical and biotechnology
companies. Nektar also develops its own products by applying its PEGylation
and
pulmonary technology platforms to existing medicines with the objective to
enhance performance, such as improving efficacy, safety and compliance.
This
press release contains forward-looking statements regarding management’s plans
and expectations for Nektar’s business including the potential of its product
pipeline. These forward-looking statements involve risks and uncertainties,
including but not limited to: (i) the Nektar's
proprietary
product candidates and those of certain of its partners are in the early phases
of clinical development and pre-clinical development and the risk of failure
is
high and can unexpectedly occur at any stage, (ii) the timing or success of
the
commencement or conclusion of planned clinical trials is subject to a number
of
uncertainties including but not limited to clinical design, patient enrollment,
regulatory requirements and clinical outcomes, (iii) Nektar's or its partner's
success in meeting minimum clinical end points and obtaining regulatory
approvals for product candidates, (iv) Nektar may not successfully complete
new
collaborative partnerships with respect to its product candidates, or if any
partnerships Nektar does negotiate do not include sufficiently favorable
commercial terms, Nektar may not receive an adequate return on these investments
and our results of operations and financial condition would suffer, (v) Nektar's
patent applications for its proprietary or partner product candidates may not
issue, patents that have issued may not be enforceable or sufficient to protect
against competitive products, or intellectual property licenses from third
parties may be required in the future, (vi) the outcome of any existing or
future intellectual property or other litigation related to Nektar's proprietary
product candidates, and (vii) potential competition from existing approved
products (branded or generic) or product candidates under development by other
companies could negatively impact the commercial potential of the Nektar's
product candidates due to such competitive factors as
efficacy and safety profiles, pricing, and reimbursement by third party payers
These forward-looking statements involve substantial risks and uncertainties,
including those risks and uncertainties that are detailed in Nektar’s reports
and other filings with the SEC including its most recent Annual Report on Form
10-K.
Contacts:
Tim
Warner (650) 283-4915 or twarner@nektar.com
Stephan
Herrera (415) 488-7699 or sherrera@nektar.com
Jennifer
Ruddock (650) 631-4954 or jruddock@nektar.com
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