Nektar
Therapeutics
201
Industrial Road
San
Carlos, California 94070
Sender
Contact Information
P: (650)
620-5990
F: (650)
620-5360
January
26, 2009
VIA ELECTRONIC
TRANSMISSION
Securities
and Exchange Commission
Division
of Corporate Finance
Washington,
D.C. 20549
Attention: Nandini
Acharya, Esq.
|
Re:
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Nektar
Therapeutics — Form 10-K for the Year Ended December 31, 2007 (File
No. 000-24006)
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Dear Ms.
Acharya:
We are in
receipt of the letter dated December 10, 2008 (the “Comment Letter”), including
comments from the staff (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) to the Form 10-K
for the year ended December 31, 2007 (File No. 000-24006) filed by Nektar
Therapeutics, a Delaware corporation (the “Registrant”), on February 29,
2008 (the “Form
10-K”). Set forth below are the Registrant’s responses to the
Staff’s comments. The numbers associated with the headings and
responses set forth below correspond to the numbered comments in the letter from
the Staff.
We
request, pursuant to 17 C.F.R. §200.83, that you accord confidential treatment
to the portions of this letter that are redacted and marked “[***]” in the
EDGAR-filed copy of this response letter and not disclose such provisions to any
person who is not an employee of the Commission unless otherwise required to do
so by law. Confidential treatment is requested to protect
confidential financial or commercial information the publication of which would
result in competitive disadvantages. Along with its redacted
EDGAR-filed copy, the Registrant is concurrently delivering an unredacted hard
copy of its response to the Commission.
Item 1. Business,
pages 6-7
Approved Products and
Clinical Pipeline
1.
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We note that the agreements
related to several of the partnered product candidates listed on your
chart on pages 6-7 are not described in your Business section or
filed as exhibits to your Form 10-K. Please expand your
disclosure in the Business section to provide a description of each of the
following agreements, including the material terms of each agreement, the
aggregate potential milestone payments, the aggregate royalty and
milestone amounts received or paid to date and the term and termination
provisions. If any of the agreements terminate upon the
last-to-expire relevant patent, please disclose the year of expiration of
such patent. Item 601(b)(10) of Regulation S-K
requires you to include material contracts as exhibits. Please
file each agreement as an exhibit to the Form 10-K or provide us with
a comprehensive analysis supporting your determination that these
agreements are not material to your
business:
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|
·
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Agreement with Solvay
Pharmaceuticals related to pulmonary
dronabinol;
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|
·
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Agreement with Amgen, Inc.
related to Neulasta®;
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|
·
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Agreement with Hoffman-La
Roche, Ltd. related to
PEGASYS®;
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|
·
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Agreement with Pfizer, Inc.
related to Somavert®;
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|
·
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Agreement with Schering-Plough
Corporation related to
PEG-INTRON®;
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|
·
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Agreement with OSI
Pharmaceuticals (formerly Eyetech) related to
Macugen®;
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|
·
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Agreement with Affymax, Inc.
related to Hematide™; and
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|
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Agreement with UCB Pharma
related to CDP 791.
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Response:
The
Registrant respectfully submits that the contracts entered in relation to
partnered product candidates are not material to the business of the Registrant
and are not required to be filed with the Form 10-K. The Registrant
further respectfully requests that the Registrant not be required to amend the
Form 10-K to expand the disclosure in the Business section. As
discussed below, given the significant events affecting the Registrant starting
in late 2007 and the substantial changes in the Registrant’s business focus in
2008, and since the contracts related to partnered product candidates were each
such as ordinarily accompany the kind of business conducted by the Registrant
and on which the Registrant was not substantially dependent, the Registrant
respectfully submits that an amendment attempting to characterize such contracts
in the context of the Registrant’s business as it existed in 2007 would not be
useful, and could be confusing, to current investors.
Historically,
the Registrant depended on revenue from its pulmonary business, in particular
contract research and manufacturing revenue from Pfizer, Inc. related to
Exubera®, an inhaled powder human insulin drug-device combination
product. Revenue from Pfizer represented 64% and 69% of the
Registrant’s total revenue for the years 2006 and 2007,
respectively. In October 2007, Pfizer announced that it was exiting
the Exubera business and, in November 2007, the Registrant entered a termination
agreement and mutual release with Pfizer (the “Pfizer
Termination”). In the Form 10-K, the Registrant disclosed that
it was seeking a new marketing and development partner for Exubera or the
related next generation inhaled insulin development program (NGI) and that
Pfizer had agreed to maintain certain manufacturing capabilities for an interim
period. On April 9, 2008, the Registrant announced that it had
ceased all negotiations with potential partners for Exubera and NGI as a result
of new data analysis from ongoing clinical trials conducted by Pfizer and would
cease all spending associated with the inhaled insulin programs.
On
October 20, 2008, the Registrant and Aerogen, Inc., a Delaware corporation and a
wholly-owned subsidiary of Nektar (“Aerogen”), entered into an
Asset Purchase Agreement (the “Asset Purchase Agreement”)
with Novartis Pharmaceuticals Corporation, a Delaware corporation, and Novartis
Pharma AG, a Swiss corporation (together with Novartis Pharmaceuticals, “Novartis”), to transfer to
Novartis certain of the assets related to the Registrant’s pulmonary business,
associated technology and intellectual property for a purchase price of $115
million in cash (the “Pulmonary
Asset Sale”). The Registrant completed the Pulmonary Asset
Sale effective as of 11:59 p.m. on December 31, 2008.
The
Registrant’s business has changed fundamentally since the Pfizer
Termination. The Registrant’s termination of its agreements with
Pfizer and the substantial revenue those agreements provided, the cessation of
spending associated with developing and maintaining the inhaled insulin programs
and the completion of the Pulmonary Asset Sale has altered the Registrant’s
business from one weighted towards investment in pulmonary technologies and
deriving a significant portion of total revenue from Pfizer to a business
focused on the PEGylation technology drug development platform that is designed
to enhance performance of a variety of drug classes and the clinical development
of product candidates based on this platform. As a result of the
Pfizer Termination and the Pulmonary Asset Sale, the Registrant is no longer
party to some of the agreements listed in the Comment Letter related to the
pulmonary business. Though the Registrant remains party to the
partnership agreements related to the PEGylation business, the contracts entered
in relation to such partnerships (i) are such as ordinarily accompany the kind
of business conducted by the Registrant and (ii) are not contracts (a) with
related parties, (b) upon which the Registrant’s business is or has been
substantially dependent, (c) calling for the acquisition or sale of any
property, plant or equipment for a consideration exceeding 15% of such fixed
assets of the Registrant on a consolidated basis or (d) that constitute material
leases. (See Item 601 under Regulation S-K.) In relation
to (b), the discussions that follow of each contract listed in Question 1
outline the percentage of total revenue related to each such contract since
2005. (Please note that any revenue amounts or percentages for 2008
included in this response to the Comment Letter are estimates and are subject to
adjustment in relation to the Registrant’s year-end financial
closing. The Registrant does not expect any adjustments related to
the year-end financial closing to materially alter the revenue amounts and
percentages in this response to the Comment Letter.)
The
Registrant will expand the disclosure in its Form 10-K for the year ended
December 31, 2008, to describe certain of its partnerships that it believes may
facilitate an understanding of its current business, though the Registrant
respectfully submits that such partnerships are not individually material to the
business of the Registrant. Below please find, in addition to
discussions of revenue related to each contract listed in Question 1, potential
disclosure related to each such contract, which the Registrant may include in
its Form 10-K for the year ended December 31, 2008.
In
relation to the Staff’s request that the Registrant include aggregate potential
milestone payments and the aggregate royalty and milestone amounts received or
paid to date, the Registrant respectfully requests that it not be required to
include such information. The Registrant respectfully submits that
disclosure of such payments and amounts is not required under Regulation S-K or
any other applicable rules or regulations because the Registrant does not
believe, as explained above, that any of the underlying partnerships is material
to the business of the Registrant and the Registrant’s business is not dependent
on revenue from any such payments or amounts. In addition, since
milestone and royalty payments are contingent on a number of factors, such as
clinical, regulatory and market success, which are subject to a number of
significant risks and uncertainties and are not typically in the control of
Registrant, the disclosure of specific milestone and royalty payments, when they
are only potential payments and might never be paid to the Registrant, could be
misleading. The specificity of such information could undermine the
Registrant’s best efforts to explain their contingency and create a false
confidence in the likelihood of receipt of such payments. Moreover,
the disclosure of such financial and commercial information would not be
customary and would result in competitive disadvantages and the release of
confidential information of the Registrant and its partners. Such
disclosure would compromise the Registrant’s position in negotiations with
future partners and would weaken the Registrant’s ability to command improved
economic terms.
In
relation to the Staff’s request that the Registrant disclose the year of
expiration of any patents that relate to a termination provision upon the
last-to-expire relevant patent, the Registrant respectfully requests that it not
be required to include such information. The expiration year of the
last-to-expire relevant patent under a contract can be difficult to determine
since patents are subject to various contingencies (as noted in relation to
enforceability, validity, scope and length of patent coverage in the section in
the Form 10-K titled “Patents and Proprietary Rights”) and the patent claims
that fall under a contract may change. Since the expiration year of
the last-to-expire relevant patent can change and disclosure of a fixed year
could be misleading, the Registrant respectfully requests that relevant contract
descriptions note that the contract terminates upon the last-to-expire relevant
patent and, in the future, the Registrant will consider disclosing a specific
year as such expirations approach.
(a)
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Agreement with Solvay
Pharmaceuticals related to pulmonary
dronabinol
|
(i) Agreement Terminated as
of September 19, 2008
In
February 2002, the Registrant entered into a research and collaboration
agreement with Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay
Pharmaceuticals, Inc., to develop a formulation of dronabinol (synthetic
delta-9-tetrahydrocannabinol) to be delivered using a metered dose inhaler as a
potential new migraine headache treatment. Under the terms of the
agreement, the Registrant was entitled to receive research and development
funding, milestone payments based on clinical progress and royalty payments on
product sales and manufacturing revenue if the product was
commercialized. On March 19, 2008, Solvay gave the Registrant notice
of termination and, pursuant to its terms, the agreement was terminated as of
September 19, 2008.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant did not derive
a significant percentage of total revenue and on which the Registrant’s business
was not substantially dependent, the agreement was not material to the business
of the Registrant and is not required to be filed with the Form
10-K.
(b)
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Agreement with Amgen,
Inc. related to Neulasta®
|
(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In July
1995, we entered into a supply and license agreement with Amgen, Inc., pursuant
to which we license our proprietary PEGylation technology to be used in the
development and manufacture of Neulasta®. Neulasta selectively
stimulates the production of neutrophils that are depleted by cytotoxic
chemotherapy, a condition called neutropenia that makes it more difficult for
the body to fight infections. We manufacture and supply our
proprietary PEGylation reagent for Amgen on a fixed price basis. The
term of the agreement is for a fixed duration with a limited number of renewal
options. We currently estimate that the last renewal term will expire
in 2010.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(c)
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Agreement with
Hoffman-La Roche, Ltd. related to
PEGASYS®
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(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In
February 1997, we entered into a license, manufacturing and supply agreement
with F. Hoffman La Roche Ltd. and Hoffman-La Roche, Inc. (Roche), under which we
granted Roche a worldwide, exclusive license to use certain PEGylation reagents
to manufacture and commercialize a certain class of products, of which Pegasys®
is the only product currently commercialized. Pegasys is approved in
the U.S., E.U. and other countries for the treatment of Hepatitis C and is
designed to help the patient’s immune system fight the Hepatitis C
virus. We currently manufacture our proprietary PEGylation reagent
for Roche on a price per gram basis. Roche has an option for a
license extension related to the agreement. The agreement expires on
the later of January 10, 2015 or the expiration of our last relevant patent
containing a valid claim, which we currently estimate to extend beyond
2015.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(d)
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Agreement with Pfizer,
Inc. related to Somavert®
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(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In
January 2000, we entered into a license, manufacturing and supply agreement with
Sensus Drug Development Corporation (subsequently acquired by Pharmacia Corp. in
2001 and then acquired by Pfizer, Inc. in 2003), for the PEGylation of
Somavert™ (pegvisomant),
a human growth hormone receptor antagonist for the treatment of
acromegaly. We currently manufacture our proprietary PEGylation
reagent for Pfizer on a price per gram basis. The agreement expires
on the later of ten years from the grant of first marketing authorization in the
designated territory, which occurred in March 2003, or the expiration of our
last relevant patent containing a valid claim, which we currently estimate at
later than March 2013. In addition, Pfizer may terminate the
agreement if marketing authorization is withdrawn or marketing is no longer
feasible due to certain circumstances, and either party may terminate for cause
if certain conditions are met.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(e)
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Agreement with
Schering-Plough Corporation related to
PEG-INTRON®
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(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In
February 2000, we entered into a manufacturing and supply agreement with
Schering-Plough Corporation (Schering) for the manufacture and supply of our
proprietary PEGylation reagent to be used by Schering in production of a
pegylated recombinant human interferon-alpha
(PEG-Intron™). PEG-Intron is a treatment for patients with Hepatitis
C. We currently manufacture our proprietary PEGylation reagent for
Schering on a price per gram basis. The agreement is for a fixed
duration with renewal terms conditioned upon mutual agreement by the parties of
new terms to be reached twelve months prior to any such renewal
period. In addition, the agreement is terminable upon twenty-four
months advance written notice by either party.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(f)
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Agreement with OSI
Pharmaceuticals (formerly Eyetech) related to
Macugen®
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(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In 2002,
we entered into a license, manufacturing and supply agreement with Eyetech
Pharmaceuticals, Inc. (subsequently acquired by OSI Pharmaceuticals, Inc. in
2005), pursuant to which we license our proprietary PEGylation technology for
the development and commercialization of Macugen®, a PEGylated anti-vascular
endothelial growth factor aptamer currently approved in the U.S. and E.U. for
use in treating age related macular degeneration. We currently
manufacture our proprietary PEGylation reagent for OSI on a price per gram
basis. Under the terms of the agreement, we will receive royalties on
net product sales in any particular country covered by a valid patent claim for
the longer of ten years from the date of the first commercial sale of the
product in that country or the manufacture, use or sale of such product in that
country. The agreement expires upon the expiration of our last
relevant patent containing a valid claim. In addition, OSI may
terminate the agreement if marketing authorization is withdrawn or marketing is
no longer feasible due to certain circumstances, and either party may terminate
for cause if certain conditions are met.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(g)
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Agreement with
Affymax, Inc. related to
Hematide™
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(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In April
2004, we entered into a license, manufacturing and supply agreement with
Affymax, Inc., under which we granted Affymax a worldwide, non-exclusive license
under certain of our proprietary PEGylation technology to develop, manufacture
and commercialize Hematide™. We currently manufacture our proprietary
PEGylation reagent for Affymax on a fixed price basis subject to annual
adjustments. Affymax has an option to convert this manufacturing
pricing arrangement to cost plus at any time prior to the date the NDA for
Hematide is submitted to the FDA. In addition, Affymax is responsible
for all clinical development, regulatory and commercialization expenses and we
are entitled to development milestones and royalties on net sales of
Hematide. Our right to receive royalties in any particular country
will expire upon the later of ten years after the first commercial sale of the
product in that country or the expiration of patent rights in that particular
country. The agreement expires on a country-by-country basis upon the
expiration of Affymax’s royalty obligations. The agreement may also
be terminated by either party for the other party’s continued material breach
after a cure period or by us in the event that Affymax challenges the validity
or enforceability of any patent licensed to them under the
agreement.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(h)
|
Agreement with UCB
Pharma related to CDP 791
|
(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In
December 2000, we entered into a licensing, manufacturing and supply agreement
with Celltech Chiroscience Ltd. (subsequently acquired by UCB Pharma) for
several PEGylated antibody fragment products, one of which was a PEG-antibody
fragment angiogenesis inhibitor for non-small cell lung cancer (CDP
791). In August 2002, the agreement was superseded by an agreement
that relates only to CDP 791. Under the terms of the 2002 agreement,
we provide development and manufacturing services for the CDP 791
product. UCB is responsible for all clinical development, regulatory
and commercialization expenses. We have the right to receive
development milestone payments, manufacturing revenue on a cost-plus basis and
royalties on net product sales following commercial launch. Our right
to receive royalties in any particular country will expire upon the later of
between ten or twelve years (which period depends on certain factors) after the
first commercial sale of the product in that country or the expiration of patent
rights in that particular country. The agreement expires upon the
expiration of all of UCB’s royalty obligations, provided that the agreement can
be extended for successive two year renewal periods upon mutual agreement of the
parties. In addition, UCB may terminate the agreement should it cease
the development and marketing of the product and either party may terminate for
cause under certain conditions.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
Item 1. Business,
pages 9-12
2.
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We note your description of
selected collaborative agreements under which you may receive milestone
payments. Please revise the discussion of these agreements to
include a description of the material terms of each agreement, including
the aggregate potential milestone payments and the aggregate amounts of
milestone payments and royalties received to
date. Additionally, please describe the term and termination
provisions. If any of the agreements terminate upon the
last-to-expire relevant patent, please disclose the year of expiration of
such patent.
|
Response:
The
Registrant respectfully requests that the Registrant not be required to amend
the Form 10-K to expand the disclosure in the Business section related to the
collaborations related to this Question 2. Given the significant
events affecting the Registrant starting in late 2007 and the substantial
changes in the Registrant’s business focus in 2008, and since the contracts
related to such collaborations were each such as ordinarily accompany the kind
of business conducted by the Registrant and on which the Registrant was not
substantially dependent, the Registrant respectfully submits that an amendment
attempting to characterize such contracts in the context of the Registrant’s
business as it existed in 2007 would not be useful, and could be confusing, to
current investors.
The
Registrant will expand the disclosure in its Form 10-K for the year ended
December 31, 2008, to describe certain of its collaborations that it believes
may facilitate an understanding of its current business, though the Registrant
respectfully submits that such collaborations are not individually material to
the business of the Registrant. Below please find potential
disclosure related to each such contract, which the Registrant may include in
its Form 10-K for the year ended December 31, 2008.
In
relation to the Staff’s request that the Registrant include aggregate potential
milestone payments and the aggregate royalty and milestone amounts received or
paid to date and disclose the year of expiration of any patents that relate to a
termination provision upon the last-to-expire relevant patent, the Registrant
respectfully requests that it not be required to include such information for
the reasons discussed above under Question 1.
(a)
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Exubera Product and
Next-Generation Inhaled Insulin Development Program (NGI) (Formerly
Partnered with Pfizer Inc.)
|
Agreement Terminated as of
November 9, 2007
In
October 2007, Pfizer announced that it was exiting the Exubera business and, in
November 2007, the Registrant entered a termination agreement and mutual release
with Pfizer. In the Form 10-K, the Registrant disclosed that it was
seeking a new marketing and development partner for Exubera or the related next
generation inhaled insulin development program (NGI) and that Pfizer had agreed
to certain maintenance activities for an interim period. On
April 9, 2008, the Registrant announced that it had ceased all negotiations
with potential partners for Exubera and NGI as a result of new data analysis
from ongoing clinical trials conducted by Pfizer and would cease all spending
associated with its inhaled insulin programs.
(b)
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NKTR-061(inhaled
Amikacin) (Partnered with Bayer
AG)
|
Draft Disclosure for Form
10-K for the Year Ended December 31, 2008
In August
2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC to develop a specially-formulated Amikacin
(NKTR-061). Under the terms of the agreement, Bayer is responsible
for most future clinical development and commercialization costs, all activities
to support worldwide regulatory filings, approvals and related activities,
further development of formulated Amikacin and final product
packaging. We are responsible for any future development of the
nebulizer device included in the Amikacin product through the completion of
Phase 3 clinical trials and scale-up for commercialization. Under the
terms of the agreement, we are entitled to development milestones and sales
milestones upon achievement of certain annual sales targets. We are
also entitled to royalties based on annual worldwide net sales of the Amikacin
product. Our right to receive these royalties in any particular
country will expire upon the later of ten years after the first commercial sale
of the product in that country or the expiration of certain patent rights in
that particular country, subject to certain exceptions. The agreement
expires in relation to a particular country upon the expiration of all royalty
and payment obligations between the parties related to such
country. Subject to termination fee payment obligations, Bayer also
has the right to terminate the agreement for convenience. In
addition, the agreement may also be terminated by either party for certain
product safety concerns, the product’s failure to meet certain minimum
commercial profile requirements or uncured material breaches by the other
party. For certain Bayer terminations, we may have reimbursement
obligations to Bayer.
(c)
|
Hemophilia Programs
(Partnered with Subsidiaries of Baxter
International)
|
Draft Disclosure for Form
10-K for the Year Ended December 31, 2008
In
September 2005, we entered into an exclusive research, development, license and
manufacturing and supply agreement with Baxter Healthcare SA and Baxter
Healthcare Corporation (Baxter) to develop products with an extended half-life
for the treatment and prophylaxis of Hemophilia A patients using our PEGylation
technology. In December 2007, we expanded our agreement with Baxter
to include the license of our PEGylation technology and proprietary PEGylation
methods with the potential to improve the half-life of any future products
Baxter may develop for the treatment and prophylaxis of Hemophilia B
patients. Under the terms of the agreement, we are entitled to
research and development funding, and we manufacture our proprietary PEGylation
reagent for Baxter on a cost plus basis. Baxter is responsible for
all clinical development, regulatory and commercialization
expenses. In relation to Hemophilia A, we are entitled to development
milestones and royalties on net sales varying by product and country of
sale. Our right to receive these royalties in any particular country
will expire upon the later of ten years after the first commercial sale of the
product in that country or the expiration of patent rights in certain designated
countries or in that particular country. In relation to Hemophilia B,
we are entitled to development and sales milestones and royalties on net sales
varying by product and country of sale. Our right to receive these
royalties in any particular country will expire upon the later of twelve years
after the first commercial sale of the product in that country or the expiration
of patent rights in certain designated countries or in that particular
country. The agreement expires in relation to a particular product
and country upon the expiration of all of Baxter’s royalty obligations related
to such product and country. The agreement may also be terminated by
either party for the other party’s material breach or insolvency, provided that
such other party has been given a chance to cure or remedy such breach or
insolvency. Subject to certain limitations as to time, and possible
termination fee payment obligations, Baxter also has the right to terminate the
agreement for convenience. We have the right to terminate the
agreement or convert Baxter’s license from exclusive to non-exclusive in the
event Baxter fails to comply with certain diligence obligations.
(d)
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Tobramycin Inhalation
Powder (TIP) Program (Formerly Partnered with Novartis Pharma
AG)
|
Agreement Terminated as of
December 31, 2008
The
Registrant was party to a collaboration with Novartis Pharma AG related to the
development of Tobramycin inhalation powder (TIP) for the treatment of lung
infections caused by the bacterium Pseudomonas aeruginosa in
cystic fibrosis patients. The collaborative research, development and
commercialization agreement with Novartis Pharma AG terminated as of December
31, 2008, as part of the closing of the Pulmonary Asset Sale. As part
of the termination, the Registrant relinquished its rights to future research
and development funding and milestone payments, as well as to any future royalty
payments or manufacturing revenue.
(e)
|
Ciproflaxin Inhalation
Powder Program (Formerly Partnered with Bayer
AG)
|
Agreement Assigned to
Novartis as of December 31, 2008
The
Registrant was party to a collaborative research, development and
commercialization agreement with Bayer Healthcare AG related to the development
of an inhaled powder formulation of Ciprofloxacin for the treatment of chronic
lung infections caused by Pseudomonas aeruginosa in
cystic fibrosis patients. As of December 31, 2008, the Registrant
assigned the collaborative research, development and commercialization agreement
to Novartis Pharma AG as part of the closing of the Pulmonary Asset
Sale. Pursuant to the terms of the Asset Purchase Agreement with
Novartis, the Registrant maintains rights to receive potential royalties in the
future based on net product sales if Ciprofloxacin receives regulatory approval
and is successfully commercialized.
(f)
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CIMZIA® Program
(Partnered with UCB)
|
Draft Disclosure for Form
10-K for the Year Ended December 31, 2008
In
December 2000, we entered into a license, manufacturing and supply agreement for
CIMZIA® (certolizumab pegol, CDP870) with Celltech Chiroscience Ltd. (which was
acquired by UCB Pharma in 2004). Under the terms of the agreement,
UCB is responsible for all clinical development, regulatory and
commercialization expenses. We have the right to receive
manufacturing revenue on a cost-plus basis and royalties on net product
sales. We are entitled to receive royalties on net sales of the
CIMZIA product in any particular country for the longer of ten years from the
first commercial sale of the product in that country or the expiration of patent
rights in that particular country. The agreement expires upon the
expiration of all of UCB’s royalty obligations, provided that the agreement can
be extended for successive two year renewal periods upon mutual agreement of the
parties. In addition, UCB may terminate the agreement should it cease
the development and marketing of CIMZIA and either party may terminate for cause
under certain conditions.
(g)
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MIRCERA (C.E.R.A.)
(Continuous Erythropoietin Receptor Activator) Program (Partnered with
Hoffman-La Roche Ltd.)
|
Draft Disclosure for Form
10-K for the Year Ended December 31, 2008
In
December 2000, we entered into a license, manufacturing and supply agreement
with Hoffman-La Roche Ltd. and Hoffman-La Roche, Inc. (Roche), which was amended
and restated in its entirety in December 2005. Pursuant to the
agreement, we license our proprietary PEGylation reagent for use in the
development and manufacture of Roche’s MIRCERA product. MIRCERA is a
novel continuous erythropoietin receptor activator indicated for the treatment
of anemia associated with chronic kidney disease in patients on dialysis and
patients not on dialysis. We are entitled to receive royalties on net
sales of the MIRCERA product in any particular country for the longer of ten
years from the first commercial sale of the product in that country or the
expiration of patent rights in that particular country. The agreement
expires upon the expiration of all of Roche’s royalty obligations, unless
earlier terminated by Roche for convenience or by either party for cause under
certain conditions.
3.
|
We note that several of the
selected collaborative agreements described in this section have not been
filed as exhibits to your Form 10-K. Please include the
following agreements as exhibits to the Form 10-K or provide us with
an analysis supporting your determination that these agreements are not
material to your business:
|
|
·
|
Collaborative Research,
Development and Commercialization Agreement with Novartis Pharma
AG;
|
|
·
|
2005 Collaboration Agreement
with Bayer AG to develop an inhaled powder formulation of a novel form of
Ciprofloxacin;
|
|
·
|
License, Manufacturing and
Supply Agreement for CIMZIA™ with UCB Pharma;
and
|
|
·
|
License, Manufacturing and
Supply Agreement for the license of your proprietary PEGylation reagent
with Hoffman-La Roche Ltd.
|
Response:
The
Registrant respectfully submits that the contracts referred to in Question 3 are
not material to the business of the Registrant and are not required to be filed
with the Form 10-K. As discussed under Question 1 above, the
Registrant’s business has changed fundamentally since the Pfizer
Termination. As a result of the Pfizer Termination and the Pulmonary
Asset Sale, the Registrant is no longer party to the collaborative research,
development and commercialization agreement with Novartis Vaccines and
Diagnostics, Inc. or the collaborative research, development and
commercialization agreement with Bayer Healthcare AG. The Registrant
remains party to the other two agreements referred to in Question 3; however,
all of the contracts referred to in Question 3 (i) are such as ordinarily
accompany the kind of business conducted by the Registrant and (ii) are not
contracts (a) with related parties, (b) upon which the Registrant’s business is
or has been substantially dependent, (c) calling for the acquisition or sale of
any property, plant or equipment for a consideration exceeding 15% of such fixed
assets of the Registrant on a consolidated basis or (d) that constitute material
leases. (See Item 601 under Regulation S-K.) In relation
to (b), the discussions that follow of each contract referred to in Question 3
outline the percentage of total revenue related to each such contract since
2005. (Please note that any revenue amounts or percentages for 2008
included in this response to the Comment Letter are estimates and are subject to
adjustment in relation to the Registrant’s year-end financial
closing. The Registrant does not expect any adjustments related to
the year-end financial closing to materially alter the revenue amounts and
percentages in this response to the Comment Letter.)
(a)
|
Collaborative
Research, Development and Commercialization Agreement for Tobramycin
inhalation powder (TIP) with Novartis Vaccines and Diagnostics,
Inc.
|
The
Registrant was party to a collaborative research, development and
commercialization agreement with Novartis Vaccines and Diagnostics, Inc. related
to the development of Tobramycin inhalation powder (TIP) for the treatment of
lung infections caused by the bacterium Pseudomonas aeruginosa in
cystic fibrosis patients. The collaborative research, development and
commercialization agreement was terminated as of December 31, 2008, as part of
the closing of the Pulmonary Asset Sale. As part of the termination,
the Registrant relinquished its rights to future research and development
funding and milestone payments, as well as to any future royalty payments or
manufacturing revenue.
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant did not derive
a significant percentage of total revenue and on which the Registrant’s business
was not substantially dependent, the agreement was not material to the business
of the Registrant and is not required to be filed with the Form
10-K.
(b)
|
2005 Collaboration
Agreement for Ciprofloxacin with Bayer Healthcare
AG
|
The
Registrant was party to a collaborative research, development and
commercialization agreement with Bayer Healthcare AG related to the development
of an inhaled powder formulation of Ciprofloxacin for the treatment of chronic
lung infections caused by Pseudomonas aeruginosa in
cystic fibrosis patients. As of December 31, 2008, the Registrant
assigned the collaborative research, development and commercialization agreement
to Novartis Pharma AG as part of the closing of the Pulmonary Asset
Sale. Pursuant to the terms of the Asset Purchase Agreement with
Novartis, the Registrant maintains rights to receive potential royalties in the
future based on net product sales if Ciprofloxacin receives regulatory approval
and is successfully commercialized.
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant has not derived
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(c)
|
License, Manufacturing
and Supply Agreement for CIMZIA™ with UCB
Pharma
|
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form
10-K. The Registrant further submits that [***] the agreement remains
a routine collaboration agreement made in the ordinary course of its business
and on which the Registrant’s business is not substantially dependent, and,
thus, the agreement is not material to the business of the Registrant and will
not be required to be filed with the Registrant’s Form 10-K for the year ended
December 31, 2008.
(d)
|
License, Manufacturing
and Supply Agreement for MIRCERA with Hoffman-La Roche
Ltd.
|
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
Patents and Proprietary
Rights, page 17
4.
|
Please expand your disclosure
in this section to address whether you developed your PEGylation and
pulmonary technology and related intellectual property internally or
whether you acquired such technology and related intellectual
property. If any of your key technology and intellectual
property was acquired, please identify the party from which it was
acquired and the material terms of the license, including exclusivity
provisions, geographic limitations, and term and termination
provisions. Please file any such license as an
exhibit.
|
Response:
As previously disclosed by the Registrant, in June 2001,
the Registrant completed the acquisition of Shearwater Corporation, a
privately-held corporation that was focused on PEGylation technology research
and development. The acquisition provided the Registrant’s initial
entry into the PEGylation business. Other than the acquisition of
Shearwater, the Registrant has developed its PEGylation technology with its own
internal research and development personnel and has substantially expanded its
intellectual property portfolio related to this business.
The
Registrant respectfully requests that the Registrant not be required to amend
the Form 10-K to expand the disclosure in the section titled “Patents and
Proprietary Rights” because the Registrant does not believe the disclosure is
material and because the Registrant disclosed the acquisition
elsewhere. The Registrant will include disclosure regarding the
Shearwater acquisition in the section titled “Patents and Proprietary Rights” in
its Form 10-K for the year ended December 31, 2008.
* * *
As
specifically requested by the Commission, the Registrant acknowledges
that:
·
|
the
Registrant is responsible for the adequacy and accuracy of the disclosure
in the filing;
|
·
|
Staff
comments or changes to disclosure in response to Staff comments do not
foreclose the Commission from taking any action with respect to the
filing; and
|
·
|
the
Registrant may not assert Staff comments as a defense in any proceeding
initiated by the Commission or any person under the federal securities
laws of the United States.
|
If you
have any questions or require any additional information with respect to any of
the matters discussed in this letter, please call the undersigned at (650)
620-5990 or Jennifer A. DePalma, Esq. at (650) 473-2670.
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Sincerely,
|
|
|
|
/s/
Gil M. Labrucherie
|
|
|
|
Gil
M. Labrucherie
|
|
Senior
Vice President, General Counsel &
Secretary
of Nektar Therapeutics
|
cc:
|
Howard
W. Robin, President and Chief Executive Officer of Nektar
Therapeutics
|
|
Sam
Zucker, Esq., O’Melveny & Myers LLP
|
|
Jennifer
A. DePalma, Esq., O’Melveny & Myers
LLP |