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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 19, 2006 (June 16, 2006)
CYTOKINETICS, INCORPORATED
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction
of incorporation)
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000-50633
(Commission File Number)
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94-3291317
(IRS Employer
Identification No.) |
280 East Grand Avenue
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
(650) 624-3000
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
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 (see General Instruction
A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.
On
June 16, 2006, Cytokinetics, Incorporated (the Company) and Glaxo Group Limited (GSK), a GlaxoSmithKline company, executed
an amendment to their Collaboration and License Agreement dated June 20, 2001 (the
Collaboration Agreement). The amendment is effective as of June 19, 2006.
Pursuant to the Collaboration Agreement, the Company formed a strategic alliance with GSK to
discover, develop and commercialize novel small molecule compounds targeting mitotic kinesin
targets for potential applications in the treatment of cancer and other diseases. In September
2005, the Company and GSK amended the Collaboration Agreement to provide the Company additional
rights to lead and fund development activities in certain hematologic cancers for one of the drug candidates that has entered
clinical trials under the strategic alliance, subject to GSKs option to resume
these activities. A further description of the material terms of the Collaboration Agreement is set
forth in the Companys Annual Report on Form 10-K for the year ended December 31, 2005, as filed
with the Securities and Exchange Commission on March 10, 2006.
The June 19, 2006 amendment extends the research term under the Collaboration Agreement for an
additional year to facilitate continued research activities under an updated research plan focused
towards the mitotic kinesin centromere-associated protein E (CENP-E). Accordingly, the research
term with respect to all mitotic kinesin targets other than CENP-E expired on June 19, 2006. Under
the amendment, GSK will have no obligation to reimburse the Company for its full-time employee
equivalents during the extension of the research term. A copy of the amendment is attached to this
Current Report on Form 8-K (Current Report) as Exhibit 10.65, and is incorporated herein by
reference.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
The following Exhibits are filed as part of this Current Report on Form 8-K:
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Exhibit No. |
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Description |
99.1
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Extension of Collaboration Press Release, dated June 19, 2006. |
10.65*
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Letter Amendment to the Collaboration Agreement, dated June 16,
2006, by and between the Company and Glaxo Group Limited, a
GlaxoSmithKline company. |
* Pursuant to a request for confidential treatment, portions of this Exhibit have been redacted from
the publicly filed document and have been furnished separately to the Securities and Exchange
Commission as required by Rule 24b-2 under the Securities and Exchange Act of 1934.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CYTOKINETICS, INCORPORATED
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By: |
/s/ James H. Sabry
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James H. Sabry |
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Chief Executive Officer |
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Dated: June 19, 2006
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INDEX TO EXHIBITS
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Exhibit No. |
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Description |
99.1
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Extension of Collaboration Press Release, dated June 19, 2006. |
10.65*
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Letter Amendment to the Collaboration Agreement, dated June 16,
2006, by and between the Company and Glaxo Group Limited, a
GlaxoSmithKline company. |
* Pursuant to a request for confidential treatment, portions of this Exhibit have been redacted from
the publicly filed document and have been furnished separately to the Securities and Exchange
Commission as required by Rule 24b-2 under the Securities and Exchange Act of 1934.
exv99w1
Exhibit 99.1
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Contacts: |
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Cytokinetics, Incorporated
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Burns McClellan, Inc. |
Robert I. Blum
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Clay Kramer (investors) |
President
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Justin Jackson (media) |
(650) 624-3000
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(212) 213-0006 |
CYTOKINETICS ANNOUNCES THE EXTENSION
OF RESEARCH COLLABORATION WITH GLAXOSMITHKLINE
South San Francisco, CA, June 19, 2006 Cytokinetics, Incorporated (Nasdaq: CYTK) announced that
it has agreed to extend the research term under its strategic alliance with GlaxoSmithKline (GSK)
for an additional year to continue research activities focused towards the mitotic kinesin,
centromere-associated protein E (CENP-E). The strategic alliance, initiated in June 2001, included
a minimum five year research term, which has generated two drug candidates that inhibit kinesin
spindle protein (KSP), ispinesib and SB-743921, and a potential drug candidate, GSK-923295, which
targets CENP-E. Ispinesib and SB-743921 are in clinical trials and GSK-923295 is in preclinical
development.
During the extension of the research term, both companies will perform research activities focused
to translational research directed towards CENP-E. CENP-E is a mitotic kinesin directly involved
in coupling the mechanics of mitosis with the mitotic checkpoint signaling machinery, regulating
cell-cycle transition from metaphase to anaphase. CENP-E is also essential for prometaphase
chromosome movements that contribute to metaphase chromosome alignment. These processes are
essential to cell proliferation. Preventing cell proliferation by disrupting mitosis is a
validated approach to treating patients with cancer.
We are pleased to extend our collaborative research with GlaxoSmithKline, stated Robert I. Blum,
President, Cytokinetics. We believe that translational research specifically focused towards
CENP-E could be helpful in support of preclinical development activities for GSK-923295 and the
expected movement of this novel compound into human clinical trials next year.
Background on Cytokinetics and GlaxoSmithKline Strategic Alliance
In June 2001, Cytokinetics and GSK announced that they had entered into a broad strategic alliance
to discover, develop and commercialize novel small molecule therapeutics targeting mitotic kinesins
for applications in the treatment of cancer and other diseases. The strategic alliance has
generated two drug candidates in clinical development, ispinesib and
SB-743921, and one potential
drug candidate in preclinical development, GSK-923295. In September 2005, Cytokinetics and GSK
announced an amendment to their original agreement to provide Cytokinetics an expanded role in the
clinical research and development of SB-743921. Under the terms of the agreement, Cytokinetics is
leading and funding development activities to explore the potential application of SB-743921 for
the treatment of non-Hodgkins lymphoma, Hodgkins lymphoma and multiple myeloma, subject to the
option for GSK to resume responsibility for development and commercialization activities for
SB-743921 for these indications during a defined period.
Background on Mitotic Kinesin Inhibitors
Since their introduction over 40 years ago, anti-mitotic drugs (taxanes and vinca alkaloids) have
advanced the treatment of cancer and are commonly used for the treatment of several tumor types.
However, these drugs have demonstrated limited treatment benefit against certain cancers. In
addition, these drugs target tubulin, a cytoskeletal protein involved not only in mitosis and cell
proliferation, but also in other important cellular functions. Inhibition of these other cellular
functions produces dose-limiting toxicities such as peripheral neuropathy, an impairment of the
peripheral nervous system. Neuropathies are thought to result when these drugs interfere with the
dynamics of microtubule filaments that are responsible for the long-distance transport of important
cellular components within nerve cells.
Mitotic kinesins are essential to mitosis, and, unlike tubulin, appear to have no role in unrelated
cellular functions. Cytokinetics believes that drugs that inhibit KSP and CENP-E and other mitotic
kinesins may represent the next generation of anti-mitotic cancer drugs by arresting mitosis and
cell proliferation without impacting unrelated, normal cellular functions, thereby avoiding many of
the toxicities commonly experienced by patients treated with existing anti-mitotic drugs.
-more-
Strategic Alliance Research Term Extension Announcement
Page 2
About Cytokinetics
Cytokinetics is a biopharmaceutical company focused on the discovery, development and
commercialization of novel small molecule drugs that specifically target the cytoskeleton. The
cytoskeleton is a complex biological infrastructure that plays a fundamental role within every
human cell. Cytokinetics focus on the cytoskeleton enables it to develop novel and potentially
safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease
and other diseases. Cytokinetics has developed a cell biology driven approach and proprietary
technologies to evaluate the function of many interacting proteins in the complex environment of
the intact human cell. Cytokinetics employs its PUMA system and Cytometrix technologies to
enable early identification and automated prioritization of compounds that are highly selective for
their intended protein targets without other cellular effects, and may therefore be less likely to
give rise to clinical side effects. Cytokinetics and GSK entered into a strategic alliance in 2001
to discover, develop and commercialize small molecule therapeutics targeting human mitotic kinesins
for applications in the treatment of cancer and other diseases. Ispinesib (SB-715992), SB-743921
and GSK-923295 are being developed under the strategic alliance with GSK. GSK is conducting Phase
II and Ib clinical trials for ispinesib and a Phase I clinical trial for SB-743921, and
Cytokinetics is conducting a Phase I/II trial of SB-743921 in non-Hodgkins lymphoma.
Cytokinetics unpartnered cardiovascular disease program is the second program to leverage the
companys expertise in cytoskeletal pharmacology. Cytokinetics is conducting a Phase I clinical
trial with CK-1827452, a novel small molecule cardiac myosin activator, for the intravenous
treatment of heart failure and also has selected CK-1827452 as a potential drug candidate for the
treatment of chronic heart failure via oral administration. Additional information about
Cytokinetics can be obtained at http://www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995 (the Act). Cytokinetics disclaims any intent or obligation to
update these forward-looking statements, and claims the protection of the Safe Harbor for
forward-looking statements contained in the Act. Examples of such statements include, but are not
limited to, statements relating to Cytokinetics research and development activities and
Cytokinetics strategic alliance with GSK, the initiation and timing of clinical trials of
GSK-923295, the potential benefits of Cytokinetics drug candidates and potential drug candidates
and the enabling capabilities of Cytokinetics proprietary technologies. Such statements are based
on managements current expectations, but actual results may differ materially due to various
factors. Such statements involve risks and uncertainties, including, but not limited to, those
risks and uncertainties relating to decisions by GSK to postpone or discontinue research
and/or development efforts or financial support for such efforts under Cytokinetics collaboration
with GSK, unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates
and other potential difficulties or delays in development, testing, regulatory approval, production
and marketing of Cytokinetics drug candidates that could slow or prevent clinical development,
product approval or market acceptance (including the risks relating to uncertainty of patent
protection for Cytokinetics intellectual property or trade secrets, Cytokinetics ability to
obtain additional financing if necessary and unanticipated research and development and other
costs) and the receipt of funds under our collaborations. For further information regarding these
and other risks related to Cytokinetics business, investors should consult Cytokinetics filings
with the Securities and Exchange Commission.
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exv10w65
Exhibit 10.65
CONFIDENTIAL
280 East Grand Avenue
South San Francisco, CA 94080
Tel (650) 624-3000 Fax (650) 624-3010
June 16, 2006
GlaxoSmithKline
2301 Renaissance Boulevard
Building #510
RN0420
King of Prussia, Pennsylvania 19406
Attn: Scott Klesmer
Director, Alliance & Joint Venture Management
Re: Extension of the Research Term with respect to CENP-E under that certain Collaboration and
License Agreement by and between Glaxo Group Limited, a GlaxoSmithKline company, (GSK) and
Cytokinetics, Inc. (CK) of even date June 20, 2001, as amended (the Collaboration Agreement)
Dear Scott:
Pursuant to this letter amendment to the Collaboration Agreement (the Letter Amendment), GSK and
CK desire to extend the Research Term solely with respect to that certain Mitotic Kinesin Target
known as CENP-E, all on the terms set forth herein.
Now therefore, GSK and CK agree, effective as of June 19, 2006 (the Letter Amendment Effective
Date), as follows:
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All capitalized terms not defined herein shall have the meaning ascribed to them in
the Collaboration Agreement. |
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2. |
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Notwithstanding GSKs obligation to notify CK in writing of its exercise of its
option to extend the Research Term under Section 2.8.1 of the Collaboration Agreement, the
Research Term shall be extended for an additional one-year period beyond Contract Year
Five (i.e., expiring June 19, 2007) solely with respect to CENP-E to allow for the conduct
of Research Program activities directed to CENP-E. Accordingly, the Research
Term with respect to all Mitotic Kinesin Targets other than CENP-E shall expire on June
19, 2006. |
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The Research Plan for the extended Research Term is attached as Exhibit A hereto. |
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Notwithstanding Section 2.8.1 of the Collaboration Agreement, GSK has no obligation
to fund any CK FTEs during the extension of the Research Term for CENP-E. |
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Confidential treatment request pursuant to a request for confidential treatment filed with
the Securities and Exchange Commission. Omitted portions have been
filed separately with the
Commission. |
CONFIDENTIAL
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Each Party agrees to execute, acknowledge and deliver such further instruments, and
to do all such other acts, as may be necessary or appropriate in order to carry out the
purposes and intent of this Letter Amendment. |
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Except as specifically modified or amended hereby, the Collaboration Agreement shall
remain in full force and effect and, as modified or amended, is hereby ratified, confirmed
and approved. No provision of this Letter Amendment may be modified or amended except
expressly in a writing signed by both Parties nor shall any terms be waived except
expressly in a writing signed by the Party charged therewith. This Letter Amendment shall
be governed in accordance with the laws of the State of New York, without regard to
principles of conflicts of laws. |
Please sign and return two copies of this letter if you agree to the foregoing terms.
Sincerely,
/s/ Robert
I. Blum
Robert I. Blum
President
Cytokinetics, Inc.
Agreed and accepted:
GLAXO GROUP LIMITED
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/s/
Paul Williamson
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Name: |
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Paul Williamson |
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Title: |
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For and on behalf of EdinBurgh
Pharmaceutical Industries Limited
Corporate Director |
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cc:
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SVP WW Business Development, GlaxoSmithKline
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Vice President & Associate General Counsel, GlaxoSmithKline R&D Legal Operations
Kenneth A. Clark, Esq., Wilson Sonsini Goodrich & Rosati Professional Corporation |
Page 2 of 3
CONFIDENTIAL
Exhibit A
Research Plan
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Page 3 of 3
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Confidential treatment request pursuant to a request for confidential treatment filed with
the Securities and Exchange Commission. Omitted portions have been
filed separately with the
Commission. |