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): March 2, 2009
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. Regulation FD Disclosure
On
March 2, 2009, Nektar Therapeutics issued a press release (the “Press Release”)
entitled “Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118
in Patients with Opioid-Induced Constipation (OIC).” A copy of the
Press Release is furnished herewith as Exhibit 99.1.
On
February 24, 2009, the company announced that it would hold a conference call on
March 2, 2009 to review its financial results for the quarter and year ended
December 31, 2008. On this conference call, management expects to
make certain forward-looking statements regarding the market potential and
revenue potential to the company for partnered product programs, the clinical
development status and certain pre-clinical and clinical results from its
proprietary product development programs including Phase 2 results for NKTR-118,
and management’s financial guidance for 2009. These forward-looking
statements involve substantial risks and uncertainties including but not limited
to: (i) NKTR-118 is in mid-stage clinical development and the risk of
failure remains high and failure can unexpectedly occur at any stage prior to
regulatory approval due to efficacy, safety or other factors; (ii) the
preliminary Phase 2 results for NKTR-118 presented in the Press Release and
further discussed on the conference call by management remain subject to change
based on completion of the final data gathering and analysis; (iii) 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; (iv) the
timing or success of the commencement or end of clinical trials and commercial
launch of partnered products may be delayed or unsuccessful due to slower than
anticipated patient enrollment, drug manufacturing challenges, changing
standards of care, clinical trial design, clinical outcomes, or delay or failure
in obtaining regulatory approval in one or more important markets; (v) clinical
trials are long, expensive and uncertain processes and the risk of failure of
any drug candidate that is in clinical development and prior to regulatory
approval remains high and can occur at any stage due to efficacy, safety or
other factors; (vi) management’s financial projections for the company’s 2009
revenue, cash used in operations and year-end cash position are subject to the
significant risk of unplanned revenue short-falls or unplanned expenses, which
could adversely affect the company’s actual 2009 financial results and end of
year cash position; (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 in the future; (viii) the outcome of any existing or future
intellectual property or other litigation related to the company’s proprietary
product candidates; (ix) the market sizes and revenue potential of the company’s
proprietary and partnered product programs are management’s current estimates
only and actual market sizes may differ materially; (x) the overall market size
for the partnered product programs and revenue and profit contribution potential
to the company will depend upon successful sales and marketing efforts by our
partners, competition from competing therapies (if any), government and private
insurance reimbursement, changing standards of care, commercial product profile
and final product pricing; and (xi) certain other important risks and
uncertainties set forth in the company’s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on February 29, 2008 and the company’s
most recent Quarterly Report on Form 10-Q to be filed on November 7,
2008. Actual results could differ materially from the forward-looking
statements contained in the Press Release and made by management during the
conference call. The company undertakes no obligation to update
forward-looking statements, whether as a result of new information, future
events or otherwise.
The information in Item 7.01 of this report 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
Number
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Description
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99.1
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Press
Release issued on March 2, 2009 by Nektar Therapeutics entitled “Nektar
Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients
with Opioid-Induced Constipation
(OIC).”
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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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March
2, 2009
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News
Release
Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with
Opioid-Induced
Constipation (OIC)
Highly
Statistically Significant Results Achieved at Two Dose Levels with No Reversal
of Analgesia
San Carlos, Calif., March 2,
2009 — Nektar Therapeutics (Nasdaq: NKTR) announced positive topline
results today from a Phase 2 double-blind, randomized, placebo-controlled study
of NKTR-118 in patients with opioid-induced constipation
(OIC). NKTR-118, a peripheral opioid antagonist, is an oral
once-a-day investigational drug to treat OIC, the most common and debilitating
manifestation of opioid-bowel dysfunction (OBD). The Phase 2 study of
NKTR-118 is terminating early on the basis of overwhelming evidence of efficacy
at two different dose levels of 25 mg once daily and 50 mg once
daily. The study achieved a clinically meaningful and highly
statistically significant, dose-dependent increase in spontaneous bowel
movements (SBMs) from baseline after the first week of NKTR-118 treatment with
the 25 mg dose and the 50 mg dose versus placebo (p < 0.01 for all
comparisons). Patients receiving the 25 mg dose of NKTR-118 had
an average of 5.1 SBMs during the first week of treatment as compared to 1.5
SBMs per week during the baseline period. Patients receiving the 50
mg dose of NKTR-118 had an average of 5.7 SBMs during the first week of
treatment versus 1.6 SBMs per week during the baseline period. The
increase in SBMs versus placebo was maintained over the 28-day treatment period
(p <0.01). More importantly, in the 25 mg and 50 mg dose cohorts,
there was no reversal of analgesia as measured by a change in pain Numerical
Rating Scale (NRS) and no increase in opiate use.
“These
data show that NKTR-118 taken orally once-daily at the 25 mg and 50 mg dose
levels dramatically increased bowel movements within the first week of treatment
for patients with OIC,” said Lynn R. Webster, M.D., Medical Director, Lifetree
Clinical Research and Pain Clinic, member of the board of directors of the
American Academy of Pain Management and lead clinical investigator for the Phase
2 Study of NKTR-118. “Further, these effects were sustained
over the entire 28-day treatment period without opiate withdrawal or reversal of
analgesia. There are no oral therapies to date that have demonstrated
as much promise as NKTR-118 to help this heterogeneous population of
patients.”
Oral
NKTR-118 combines Nektar's advanced small molecule polymer conjugate technology
platform with naloxol, a derivative of the opioid-antagonist drug, naloxone.
Nektar’s technology has been shown to increase oral bioavailability and reduce
penetration across the blood-brain barrier, an important potential advance for
many other small molecule therapies.
“NKTR-118
demonstrates that our advanced polymer conjugate technology can potentially
create new small molecule drugs with optimal physicochemical and pharmacological
properties,” said Howard W. Robin, President and CEO of Nektar. “Nektar is well-
recognized as the industry leader in large molecule PEGylation. This validation of our platform with small molecules is a major achievement for Nektar and sets the stage for the future growth of our pipeline.”
About
the Phase 2 Study for NKTR-118
The Phase
2 study for NKTR-118, in 208 pain patients experiencing OIC, was an
international, multicenter, randomized, double-blind, dose-escalation,
placebo-controlled trial.
The
primary endpoint of the study was a change in SBMs from a two-week baseline
period during which the patient had to demonstrate significant constipation in
the absence of laxatives, to the change in SBMs at the end of the first week of
randomized study drug. Patients in the study were being treated for
moderate to severe pain with 30 to 1,000 morphine equivalent
units. Under the study protocol, patients were randomly assigned to
placebo or one of three different dose cohorts (5 mg, 25 mg, and 50 mg given as
a single daily oral dose) for a treatment period of four weeks. In
addition to measures of SBMs, patients also recorded daily use of opiates and
pain NRS scores.
Secondary
endpoints included reversal of analgesia as measured by a change in pain NRS or
increase in opiate use during the 28-day treatment period. NKTR-118
did not result in an increase in pain and was not associated with an increase in
opiate use at any time during the 28-day treatment period at any
dose. NKTR-118 was also not associated with opiate withdrawal as
assessed by a change in the Clinical Opiate Withdrawal Scale. The most frequent
side effects observed in the study that led to discontinuation of medication
were diarrhea, nausea and abdominal cramping. These side effects were
most frequent in the 50 mg dose group.
Final
patients in the 50 mg dose cohort are completing treatment. Final
results from the Phase 2 study are expected to be presented at scientific and
medical conferences in 2009. The results of the Phase 2 study will
enable Nektar to evaluate the drug in Phase 3 pivotal trials in order to submit
a New Drug Application (NDA) to the Food and Drug Administration
(FDA).
About
NKTR-118
Oral
NKTR-118 combines Nektar's advanced small molecule polymer conjugate technology
platform with naloxol, a derivative of the opioid-antagonist drug, naloxone.
Nektar’s technology has been shown to increase oral bioavailability and reduce
penetration of oral NKTR-118 across the blood-brain barrier, an important
potential advance for this and possibly many other small molecule
therapies.
The
antagonist NKTR-118 targets mu-opioid receptors within the enteric nervous
system, which mediate OBD, a symptom complex resulting from opioid use that
encompasses constipation, bloating, abdominal cramping, and gastroesophageal
reflux. Constipation is the hallmark of this syndrome and is generally its most
prominent component. In patients who take opiates chronically for pain
management, anywhere from 45-90% of patients will develop debilitating
constipation associated with other symptoms of opiate-induced bowel dysfunction
as a result of the opiate binding to the mu-opioid receptor in the gut1.
According
to IMS Health, about 230 million prescriptions were written for opioids in 2007
in the United States alone. Currently, there are no oral drugs
approved that are indicated to treat OIC. OBD and OIC can
significantly impact quality of life and increase healthcare
utilization.
Conference
Call to be Held at 2 PM Pacific time, Monday, March 2, 2009
Howard
Robin, president and chief executive officer, and John Nicholson, chief
financial officer, will host a conference call to discuss today’s announcement
and the company’s fourth quarter and year-end 2008 financial
results.
The call
will be held today, March 2, 2009, at 5:00 p.m. Eastern Time (ET)/2:00 p.m.
Pacific Time (PT). A live audio-only Webcast of the conference call
can be accessed through a link that is posted on the home page and Investor
Relations section of the Nektar website: http://www.nektar.com.
To access
the conference call by telephone, please follow these instructions:
Dial:
800.561.2718 (U.S.); 617.614.3525 (international)
Participant
Passcode: 32041145 (Howard Robin is the host)
An audio
replay will also be available shortly after the call and will remain so through
March 16, 2009.
To access
the replay, follow these instructions:
Dial:
888-286-8010 (U.S.); 617-801-6888 (international)
Participant
Passcode: 44161634
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 for partners, which include leading
biopharmaceutical companies. Nektar is also developing a robust pipeline of its
own potentially high-value therapeutics that addresses unmet medical needs by
leveraging and expanding its technology platforms to improve and enable
molecules.
This
press release contains forward-looking statements that reflect the company's
current views regarding the potential of the company’s technology platforms and
the potential of NKTR-118 and the results of the Phase 2 study for that drug
candidate. These forward-looking statements involve risks and uncertainties,
including but not limited to: (i) NKTR-118 is in mid-stage clinical development
and the risk of failure remains high and failure can unexpectedly occur at any
stage 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 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; (iv) the outcome of any existing or future intellectual
property or other litigation related to the company’s proprietary product
candidates; and (v) the preliminary Phase 2 results for NKTR-118 described in
this press release remain subject to completion of final data gathering and
analysis and therefore this data remains subject to change. 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.
Actual
results could differ materially from the forward-looking statements contained in
this press release. The company undertakes no obligation to update
forward-looking statements, whether as a result of new information, future
events or otherwise. For more information on Nektar Therapeutics, please visit
http://www.nektar.com.
Jennifer
Ruddock, 650-631-4954
Nektar
Therapeutics
Susan A.
Noonan, 212-966-3650
The SAN
Group
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.
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