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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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¨
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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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1.
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The
Company’s proprietary drug candidates, including NKTR-118, NKTR-102,
Amikacin Inhale, and NKTR-105, are in early to mid-stage clinical
development and the risk of failure remains high and can unexpectedly
occur at any stage prior to regulatory approval due to lack of efficacy,
safety issues, manufacturing challenges or other factors that can impact
drug development.
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2.
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The
preliminary Phase 2 results for NKTR-102 in ovarian and breast cancer
remain subject to final data gathering and analysis review and audit
confirmation procedures and the final results for the ovarian and breast
cancer trials may differ materially and adversely after this review is
completed.
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3.
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The
preliminary Phase 2 results for overall survival in NKTR-102 in platinum
resistant/refractory ovarian cancer were as of January 3, 2011, and as the
study progresses (including the expansion study) and after the audit and
verification procedures are completed, the final overall survival results
may change and such change could be material and
adverse.
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4.
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The
expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer could change the efficacy results (e.g. overall response
rates, progression-free survival, etc.) and safety observations (i.e.,
frequency and severity of serious adverse events). As such, the
previously announced results from the Phase 2 study for ovarian cancer
remain subject to change and the final results could be materially and
adversely different from results previously
announced.
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5.
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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, review and/or approval of an NDA by the FDA based on Phase 2
results for NKTR-102 in platinum-resistant/refractory ovarian cancer prior
to completion of Phase 3 clinical studies would be unusual and is highly
unlikely.
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6.
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The
preliminary clinical results from the NKTR-102 clinical trial in
metastatic breast cancer reported by the Company in a press release issued
on December 12, 2010 and that will be reviewed in Mr. Robin’s presentation
were as of October 26, 2010. As such, these data are subject to
change and the final results could be materially and adversely different
as the Phase 2 clinical trial continues and after the audit and
verification procedures are
completed.
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7.
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The
timing and/or success of the commencement or end of clinical trials,
including without limitation the anticipated Phase 3 commencement for
NKTR-118 and Amikacin Inhale, may be delayed or unsuccessful due to
regulatory delays, clinical trial design (and regulatory concurrence for
design), slower than anticipated patient enrollment, manufacturing
challenges, changing standards of care or clinical
outcomes. For example, the Company has experienced significant
delays in finalizing the commercial device design for Amikacin Inhale and
successful completion of this device design and commercial scale-up effort
is an important element to meeting the planned start of the Phase 3 trial
in 2011 and these activities are ongoing and remain subject to a
substantial risk of failure until such activities are successfully
completed.
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8.
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Scientific
discovery of new medical breakthroughs is an inherently uncertain process
and the future success of the application of the Company’s technology
platforms 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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9.
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The
Company’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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10.
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The
outcome of any existing or future intellectual property or other
litigation related to the Company’s proprietary product candidates or
partner product candidates where the Company has indemnification
responsibility is unpredictable and could have a material adverse effect
on our business, results of operations and financial
condition.
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11.
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The
market sizes for the Company’s proprietary and partnered product programs
are based on management’s current estimates only and actual market sizes
may differ materially and
adversely.
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12.
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Other
important risks and uncertainties set forth in the Company’s Quarterly
Report on Form 10-Q filed with the SEC on November 4, 2010 for the quarter
ended September 30, 2010.
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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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||
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Date:
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January
11, 2011
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