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): June 9, 2010
NEKTAR
THERAPEUTICS
(Exact
Name of Registrant as Specified in 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 2.02
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Results
of Operations and Financial
Condition
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On June
9, 2010, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press
release (the “Press Release”) announcing initial results from a Phase 2 clinical
study evaluating NKTR-102 in women with metastatic breast cancer. A
copy of the Press Release is furnished herewith as Exhibit 99.1.
On June
3, 2010, Nektar announced that Howard W. Robin, President and Chief Executive
Officer of Nektar, would present at the Jefferies 2010 Global Life Sciences
Conference at The Grand Hyatt New York on Wednesday, June 9, 2010 at 10:00 a.m.
Eastern Time. This presentation is being webcast and may be accessed
in the Events Calendar section on the homepage of Nektar’s website at
www.nektar.com. At this presentation Nektar expects to make certain
forward-looking statements regarding the potential therapeutic benefit of
NKTR-102, the future clinical development and regulatory plans for NKTR-102,
NKTR-105, NKTR-118 and certain other of Nektar’s drug candidates in research and
development, the potential and timing for a collaboration partnership for
NKTR-102, the market potential of NKTR-102 and other of Nektar’s drug
candidates, and certain other statements regarding the prospects and potential
of Nektar’s business, technology platform and drug candidate
pipeline. These forward-looking statements involve substantial risks
and uncertainties, including but not limited to the following:
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(i)
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NKTR-102
is in early stage clinical development and the risk of failure remains
high, and failure can unexpectedly occur at any stage for one or more of
the cancer indications being studied (i.e., ovarian cancer, breast cancer,
and colorectal cancer) due to lack of sufficient efficacy, safety concerns
or other important factors that impact drug development and regulatory
approval;
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(ii)
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the
Phase 2 results for NKTR-102 in breast cancer described in the Press
Release and presented by Nektar management at the Jefferies conference
remain subject to data audit confirmation procedures, and the
reported results may change materially and adversely after such
review is completed;
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(iii)
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the
initial preliminary RECIST response data for the NKTR-102 clinical trial
in breast cancer reported in the Press Release and to be discussed at the
Jefferies conference is subject to substantial change and such substantial
change could be material and adverse—in particular, there is no way to
predict whether unconfirmed responses will become confirmed responses as
the clinical trial progresses;
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(iv)
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additional
important data will be reported by Nektar in the future regarding the
NKTR-102 clinical study in breast cancer including but not limited to
confirmed/unconfirmed RECIST response rates, progression-free survival,
overall survival and further safety information regarding the frequency
and severity of adverse events observed, and therefore the complete and
final results for the Phase 2 breast cancer trial may differ materially
and adversely from the results reported in the Press Release and at the
Jefferies conference;
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(v)
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the
initial results from the NKTR-102 clinical study in breast cancer are not
necessarily indicative or predictive of the future results of NKTR-102 in
any other cancer indications for which it is currently being studied
(i.e., ovarian and colorectal
cancers);
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(vi)
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the
data package required and the timing for regulatory approval of a new drug
application (NDA) by the Food and Drug Administration (FDA) is very
uncertain and difficult to predict due to broad regulatory discretion,
changing standards of care, available approved therapies, the size of
completed clinical trials and the statistical significance of the results,
the potential need for comparative clinical studies against approved
therapies, and other important factors that are very unpredictable and not
within Nektar’s control;
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(vii)
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approval
of an NDA by the FDA almost always requires the sponsor to conduct Phase 3
clinical studies prior to consideration and approval of an NDA and, as a
result, approval of an NDA by the FDA based on Phase 2 results prior to
completion of Phase 3 clinical studies is highly
unlikely;
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(viii)
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the
expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer in the Q21 dose group, which Nektar announced on Monday,
June 7, 2010 at a webcast breakfast meeting, will necessarily result in
changes to the final efficacy (e.g., overall response rates,
progression-free survival, overall survival) and safety (i.e., frequency
and severity of adverse events) results for the Phase 2 clinical trial in
ovarian cancer, and, as such, the complete and final results in the Q21
dose group remain subject to change and could be materially and adversely
different from the results previously announced by Nektar in a press
release furnished on Exhibit 99.1 to the Current Report on Form 8-K filed
with the Securities and Exchange Commission on June 7,
2010;
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(ix)
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the
timing or success of the commencement or end of clinical trials and
commercial launch of new drugs may be delayed or unsuccessful due to
regulatory delays, clinical trial design, slower than anticipated patient
enrollment, drug manufacturing challenges, changing standards of care,
clinical outcomes, or delay or failure in obtaining regulatory approval in
one or more important
markets;
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(x)
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scientific
discovery of new medical breakthroughs is an inherently uncertain process,
and the future success of the application of Nektar’s technology platform
to potential new drug candidates is therefore very uncertain and
unpredictable and one or more research and development programs could
fail;
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(xi)
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Nektar’s
patent applications for its proprietary or partner product candidates may
not issue, patents that have issued may not be enforceable, or additional
intellectual property licenses from third parties may be required in the
future;
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(xii)
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the
outcome of any existing or future intellectual property or other
litigation related to Nektar’s proprietary product candidates, including
without limitation NKTR-102, NKTR-118, NKTR-105 and other of Nektar’s drug
candidates, is unpredictable and could have a material adverse effect on
our business, results of operations and financial condition and the
prospects for commercialization of one or more of Nektar’s drug
candidates;
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(xiii)
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the
market potential for NKTR-102, NKTR-118, NKTR-105 and other of Nektar’s
drug candidates is based on management’s current estimates only, and
actual market size may differ materially and
adversely;
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(xiv)
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if
Nektar is unable to establish and maintain collaboration partnerships or
appropriate transaction structures relating to its drug candidates (e.g.,
NKTR-102) on attractive commercial terms, our business, results of
operations and financial condition could suffer;
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(xv)
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the
timing of any new collaboration partnerships is difficult to predict due
to availability of clinical data, the number of potential partners that
need to complete due diligence and approval processes, and numerous other
unpredictable factors that can delay, impede or prevent partnering
transactions from being consummated;
and
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(xvi)
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certain
other important risks and uncertainties set forth in Nektar’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2010 filed on May 6,
2010, and the Annual Report on Form 10-K for the year ended December 31,
2009, filed on March 3, 2010.
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Actual
results could differ materially from the forward-looking statements contained in
the Press Release and those made by Nektar management at the Jefferies
conference. Nektar undertakes no obligation to update forward-looking
statements whether as a result of new information, future events or otherwise,
including without limitation updated clinical trial results or regulatory
communications.
The
information in this report, including the exhibit hereto, is being furnished and
shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liabilities of
that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as
amended. The information contained herein and in the accompanying exhibit shall
not be incorporated by reference into any filing with the Securities and
Exchange Commission made by Nektar Therapeutics, whether made before or after
the date hereof, regardless of any general incorporation language in such
filing.
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Item 9.01
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Financial
Statements and Exhibits
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Exhibit
No.
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Description
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99.1
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Press
release titled “Nektar Therapeutics Announces Positive Initial Results
from Phase 2 Study of NKTR-102 in Metastatic Breast Cancer” issued by
Nektar Therapeutics on June 9,
2010.
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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
General
Counsel and Secretary
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Date:
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June 9, 2010 | ||
EXHIBIT
INDEX
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Exhibit
No.
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Description
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99.1
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Press
release titled “Nektar Therapeutics Announces Positive Initial Results
from Phase 2 Study of NKTR-102 in Metastatic Breast Cancer” issued by
Nektar Therapeutics on June 9,
2010.
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Exhibit
99.1
News
Release
Nektar
Therapeutics Announces Positive Initial Results from
Phase
2 Study of NKTR-102 in Metastatic Breast Cancer
San Carlos, Calif., June 9,
2010 – Nektar Therapeutics (Nasdaq: NKTR) today announced positive
preliminary initial results from a two-stage Phase 2 clinical study evaluating
single-agent NKTR-102 in women with advanced/metastatic breast cancer patients
who have received a prior taxane. The increased use of taxanes in
breast cancer often renders tumors resistant to these drugs by the time the
disease recurs, thereby underscoring the urgent need for new treatment options
with novel mechanisms of action for metastatic disease.
The
single-agent NKTR-102 study recently completed enrollment with a total of 70
patients with metastatic breast cancer. A significant majority of the
women had been treated with prior anthracycline/taxane with or without
capecitabine. Of the 70 patients, 66 patients are currently evaluable
per RECIST for the imaging-based primary endpoint of objective response
rate. Confirmed and unconfirmed RECIST responses were 21% (14/66)
overall for single-agent NKTR-102, with 18% (6/33) for the q14d dose regimen and
24% (8/33) for the q21d dose regimen. There are a significant number of patients
in the study still on therapy with NKTR-102.
“This is
a very promising result in patients with metastatic breast cancer who have
failed prior taxanes and in most cases, prior anthracyclines,” said Prof. Ahmad
Awada, Head of the Gynecologic Oncology Clinic at the Institut Jules Bordet in
Brussels, Belgium. “I have patients who have not responded to any
prior therapy but who have experienced a good response to
NKTR-102. These data are quite encouraging, and NKTR-102 should be
taken forward as a single agent and in combination therapy in patients with
difficult-to-treat disease such as triple- negative breast cancer and
anthracycline/taxane failures.”
Of the 70
patients enrolled in the study, approximately 85% had received prior
anthracycline/ taxane, either with or without capecitabine
therapy. The drug has been well-tolerated to-date. The
most commonly observed grade 3 or grade 4 side effects in the study to date
(every 14 day/every 21 day dose schedule) were diarrhea (14%/6%) and neutropenia
(9%/6%). There were low rates of alopecia observed with single-agent
NKTR-102, with only a small number of women experiencing Grade 2
alopecia.
“We are
highly encouraged by the compelling preliminary activity observed to-date in the
patients from our study,” said Lorianne Masuoka, M.D., Senior Vice President and
Chief Medical Officer. “This, combined with our recent results presented
at the 2010 ASCO meeting for single-agent NKTR-102 in women with
platinum-resistant and refractory ovarian cancer, make us very excited about the
future of NKTR-102 as a novel anti-cancer agent.”
About
the Study
The Phase
2 study is evaluating two dose regimens (q14 day and q21 day) of single-agent
NKTR-102 in women with metastatic breast cancer. The study employs a
two-stage design, with 40 patients in the first stage and 30 patients in the
second stage. Secondary endpoints of the Phase 2 study include
progression-free survival and safety.
About
Metastatic Breast Cancer
Breast
cancer is one of the most common cancers among every major ethnic group of women
in the United States. The chance of developing invasive breast cancer at some
time in a woman's life is a little less than 1 in 8 (12%). According
to the American Cancer Society, nearly 200,000 new cases of invasive breast
cancer were diagnosed in women in 2009. Anthracyclines and taxanes
are the most active and widely used chemotherapeutic agents for breast cancer,
but the increased use of these agents at an early stage of disease often renders
tumors resistant to these drugs by the time the disease recurs, thereby reducing
the number of treatment options for metastatic disease. Drugs used to treat
patients who progress following AT treatment can be as high as 20-30%; however,
resistance develops rapidly and new agents with different mechanisms of action,
such as topoisomerase I-inhibitors, are needed to allow novel ways to overcome
the problem of drug resistance.1 There
are currently no FDA-approved topoisomerase-I inhibitors to treat breast
cancer.
About
NKTR-102
Nektar is
developing NKTR-102, a topoisomerase I inhibitor-polymer conjugate with reduced
peak concentrations and a continuous concentration profile. NKTR-102
was invented by Nektar using its advanced polymer conjugate technology platform,
and is the first oncology product candidate to leverage Nektar's releasable
polymer technology platform.
In
addition to the fully-enrolled Phase 2 studies in platinum-resistant ovarian
cancer and metastatic breast cancer, NKTR-102 is also being tested in a separate
Phase 2 clinical trial in patients with second-line colorectal cancer and a
Phase 1 clinical trial of NKTR-102 evaluating it in combination with 5-FU
therapy.
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 leading biopharmaceutical company partners,
including UCB's Cimzia(R) for Crohn's disease and rheumatoid arthritis, 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. In addition to the releasable polymer technology,
Nektar is the first company to create a permanent small molecule-polymer
conjugate with enhanced oral bioavailability and restricted entry into the CNS.
Nektar is currently conducting clinical and preclinical programs in oncology,
pain and other therapeutic areas. Nektar recently entered into an exclusive
worldwide license agreement with AstraZeneca for its oral NKTR-118 program to
treat opioid-induced constipation and its NKTR-119 program for the treatment of
pain without constipation side effects. NKTR-102 is being evaluated in Phase 2
clinical studies for the treatment of ovarian, breast and colorectal cancers.
NKTR-105 is in a Phase 1 clinical study in cancer 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 programs and capabilities may be found online at http://www.nektar.com.
This
press release contains forward-looking statements that reflect Nektar's current
views regarding the potential of Nektar's technology platform, the potential of
NKTR-102 for breast cancer patients, and preliminary initial results from the
Phase 2 clinical trial of NKTR-102 in metastatic breast cancer. These
forward-looking statements involve substantial risks and uncertainties,
including but not limited to one or more of the following: (i) NKTR-102 is in
early stage clinical development and the risk of failure remains high and
failure can unexpectedly occur at any stage for one or more of the cancer
indications being studied (i.e. ovarian cancer, breast cancer, and colorectal
cancer) due to efficacy, safety or other unpredictable factors; (ii) the initial
preliminary RECIST response data for the NKTR-102 clinical trial in breast
cancer reported in this press release is subject to substantial change and such
substantial change could be material and adverse—in particular, there is no way
to predict whether unconfirmed responses will become confirmed responses as the
clinical trial progresses; (iii) the Phase 2 results for NKTR-102 in breast
cancer described in this press release remain subject to data audit confirmation
procedures, and the reported results may change materially and adversely after
such review is completed; (iv) additional important data will be reported by
Nektar in the future regarding the NKTR-102 clinical study in breast cancer
including but not limited to confirmed/unconfirmed RECIST response rates,
progression-free survival, overall survival and further safety information
regarding the frequency and severity of adverse events observed in the study,
and therefore the complete and final results for the Phase 2 breast cancer trial
may differ materially and adversely from these preliminary initial results; (v)
the timing or success of the commencement or end of clinical trials and
commercial launch of new drugs may be delayed or unsuccessful due to regulatory
delays, clinical trial design, slower than anticipated patient enrollment, drug
manufacturing challenges, changing standards of care, clinical outcomes, or
delay or failure in obtaining regulatory approval in one or more important
markets; (vi) this early preliminary data from the NKTR-102 clinical study for
breast cancer is not necessarily predictive of the outcomes for other cancer
indications for which NKTR-102 is being studied (i.e. ovarian and colorectal
cancers); (vii) the data package required and the timing for regulatory approval
of a new drug application is very uncertain and difficult to predict due to
broad regulatory discretion, changing standards of care, available approved
therapies, the size of the completed clinical trials and the statistical
significance of the results, the potential need for comparative clinical studies
against approved therapies, and other important variables that are not within
the control of Nektar; (viii) Nektar's patent applications for its proprietary
or partner product candidates may not issue, patents that have issued may not be
enforceable, or additional intellectual property licenses from third parties may
be required in the future; (ix) the uncertain outcome of any future intellectual
property, commercial or other litigation related to Nektar's proprietary product
candidates, including without limitation NKTR-102; (x) if Nektar is unable to
establish and maintain collaboration partnerships on attractive commercial
terms, our business, results of operations and financial condition could
suffer; and (xi)
certain other important risks and uncertainties set forth in Nektar’s Current
Report on Form 8-K filed today, the Quarterly Report on Form 10-Q for the
quarter ended March 31, 2010, filed on May 6, 2010, and the most recent
Annual Report on Form 10-K for the year ended December 31, 2009, filed on March
3, 2010. Actual results could differ materially from the
forward-looking statements contained in this press release. Nektar
undertakes no obligation to update forward-looking statements whether as a
result of new information, future events or otherwise including without
limitation future clinical and regulatory developments.
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Nektar
Investor Inquiries:
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Jennifer
Ruddock
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(650)
283-6253
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Susan
Noonan/SAN Group
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(212)
966-3650
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Nektar
Media Inquiries:
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Karen
Bergman/BCC Partners
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(650)
575-1509
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Michelle
Corral/BCC Partners
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(415)
794-8662
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#
# #
1 Alvaro
and Perez, Mayo Clin Proc. 2009; 84(6):533-545