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): January 12, 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
7.01
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Regulation
FD Disclosure
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On
January 12, 2010, Nektar Therapeutics issued a press release (the “Press
Release”) announcing its preliminary results from the first stage of the Phase 2
Study in platinum-resistant ovarian cancer. A copy of the Press
Release is furnished herewith as Exhibit 99.1.
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 Topline Results for
NKTR-102 From First Stage of Phase 2 Study in Platinum-Resistant Ovarian
Cancer,” issued on January 12,
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
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General
Counsel and Secretary
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Date:
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January
12, 2010
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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 Topline Results for
NKTR-102 From First Stage of Phase 2 Study in Platinum-Resistant Ovarian
Cancer,” issued on January 12,
2010.
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News
Release
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Nektar
Therapeutics Announces Positive Topline Results for NKTR-102
From
First Stage of Phase 2 Study in Platinum-Resistant Ovarian Cancer
San Carlos, Calif., January 12,
2010 – Nektar Therapeutics (Nasdaq: NKTR) today
announced preliminary results from the first stage of a two-stage Phase 2
clinical study evaluating NKTR-102 in women with platinum-resistant ovarian
cancer. In the first stage of the study, 39 patients enrolled with
platinum-resistant disease were evaluable for the primary endpoint of overall
response rate using Gynecologic Cancer InterGroup (GCIG) criteria, i.e., a
combination of response by tumor imaging (RECIST) and/or ovarian cancer
biomarker (CA-125) criteria(1). The first stage of the NKTR-102 Phase 2
study showed an overall GCIG response rate of 32% (6/19) in the once every 14
days (q14 day) dose schedule and 35% (7/20) for the once every 21 days (q21 day)
dose schedule. Confirmed objective response rates using RECIST were
21% (4/19) and 22% (4/18) for the q14 day and q21 day dose schedules,
respectively. CA-125 response rates were 31% (5/16) and 38% (6/16),
for each dose schedule, respectively. The Phase 2 study has now
completed enrollment with a total of 71 patients. Approximately
one-third of the patients in the study remain on NKTR-102 treatment, including a
number of patients in the first stage of the study.
"The early and dramatic reductions in
CA-125 in many of the patients with platinum-resistant and refractory ovarian
cancer indicate that NKTR-102 has great therapeutic potential," said Prof. Dr.
Ignace Vergote, Head of the Department of Obstetrics and Gynaecology and
Gynaecologic Oncology at the Catholic University of Leuven, European Union and
Lead Investigator of the NKTR-102 study. "NKTR-102 is one of the most
promising agents for platinum-resistant ovarian cancer I have seen in 25 years,
as evidenced by the number of women in the study with tumor response and rapid
biochemical response. This drug warrants further definitive Phase 3 testing as
quickly as possible. The investigators look forward to presenting the
final data at an upcoming scientific meeting."
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 (29%/10%) and neutropenia
(14%/10%).
"This population of heavily pre-treated
patients, which includes a high proportion of women with platinum-refractory
disease, is among the most challenging to treat in oncology," said Lorianne
Masuoka, M.D., Senior Vice President and Chief Medical
Officer. "Almost half of the patients in the first stage of our study
had platinum-refractory disease, having progressed within three weeks of their
last platinum regimen. We are highly encouraged by the compelling
efficacy seen to-date in the patients from the first stage of our
study. This efficacy is accompanied by a favorable safety profile
with regard to both GI side effects and neutropenia."
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
platinum-resistant ovarian cancer. The study employs a two-stage
design, with 41 patients in the first stage and 30 patients in the second
stage. Two patients in the q14 day dose regimen in the first stage
had platinum-sensitive disease and were not evaluable for the primary outcome
measure. 44% of the patients in the first stage were
platinum-refractory, having progressed within three weeks of their last platinum
therapy. 77% of the patients in the first stage had a platinum-free
interval of less than three months (progression within three months of last
platinum therapy). Secondary endpoints of the Phase 2 study include
progression-free survival and safety.
CA-125 is a biochemical marker that is
found in the blood of ovarian cancer patients and is measured to assess disease
progression and recurrence. RECIST classifies response based upon
tumor reduction measured by imaging methods.
Ovarian cancer is the fifth leading
cause of cancer deaths among women, accounting for more deaths than any other
cancer of the female reproductive system(2). Agents currently approved by
the U.S. Food & Drug Administration to treat women with platinum-resistant
ovarian cancer have modest overall response rates of between 6.5 to
13.8%(3,4).
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 study currently underway in platinum-resistant ovarian cancer, NKTR-102 is
also being tested in two separate Phase 2 clinical trials in patients with
metastatic breast cancer and second-line colorectal cancer.
The company also announced today that it
has opened the second stage of its Phase 2 study of NKTR-102 in women with
metastatic breast cancer evaluating two dose regimens (q14 and q21 day dose
schedules). Enrollment of the first stage of this two-stage study is
complete for both regimens (20 patients per regimen).
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 the company's current views regarding
the potential of the company's technology platforms, the potential of
NKTR-102, preliminary results from stage 1 of a Phase 2 study for
NKTR-102 in ovarian cancer, and an update on the status of a two stage Phase 2
study of NKTR-102 in 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) prior to regulatory approval due to
efficacy, safety or other factors; (ii) 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; (iii) the preliminary
Phase 2 results for NKTR-102 in ovarian cancer patients in stage 1 described in
this press release is preliminary data only and remains subject to final data
gathering and analysis review procedures; (iv) the preliminary results from
stage 1 of the NKTR-102 clinical study for ovarian cancer is not necessarily
indicative or predictive of the future results from stage 2 of this clinical
study and therefore the outcome remains uncertain; (v) the company's patent
applications for its proprietary or partner product candidates may not issue,
patents that have issued may not be enforceable, or intellectual property
licenses from third parties may be required in the future; (vi) the data from
clinical studies in Nektar-102 from any particular cancer indication is not
necessarily predictive of the outcomes for other cancer indications for which
NKTR-102 is being studied by the company; (vii) the company's patent
applications for its proprietary or partner product candidates may not issue,
patents that have issued may not be enforceable, or intellectual property
licenses from third parties may be required; and (vii) the outcome of any
existing or future intellectual property or other litigation related to the
company's proprietary product candidates including without limitation
NKTR-102. Other important risks and uncertainties are detailed in the
company's reports and other filings with the Securities and Exchange Commission,
including its most recent Quarterly Report on Form 10-Q and Annual Report on
Form 10-K. Nektar undertakes no obligation to update forward-looking
statements, whether as a result of new information, future events or
otherwise.
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Nektar
Investor Inquiries:
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Jennifer
Ruddock/Nektar Therapeutics
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(650)
631-4954
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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 2008
International Gynecologic Cancer Society. Gynecological Cancer Intergroup,
http://www.gcig.igcs.org/CA-125.html
2 American Cancer Society,
2009.
3 Gordon
et al., Journal of Clinical
Oncology 2001, 19: 3312-3322
4 Doxil US
Package Insert, 2008. http://www.doxil.com/