e8vk
Table of Contents

 
 
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)
         
Delaware
(State or other jurisdiction
of incorporation)
  000-50633
(Commission File Number)
  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
(Registrant’s 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.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
SIGNATURES
INDEX TO EXHIBITS
EXHIBIT 99.1
EXHIBIT 10.65


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 GSK’s option to resume these activities. A further description of the material terms of the Collaboration Agreement is set forth in the Company’s 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:
     
Exhibit No.   Description
99.1
  Extension of Collaboration Press Release, dated June 19, 2006.
10.65*
  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.
         
  CYTOKINETICS, INCORPORATED
 
 
  By:   /s/ James H. Sabry    
    James H. Sabry   
    Chief Executive Officer   
 
Dated: June 19, 2006

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INDEX TO EXHIBITS
     
Exhibit No.   Description
99.1
  Extension of Collaboration Press Release, dated June 19, 2006.
10.65*
  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
     
Contacts:
   
 
Cytokinetics, Incorporated
  Burns McClellan, Inc.
Robert I. Blum
  Clay Kramer (investors)
President
  Justin Jackson (media)
(650) 624-3000
  (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-Hodgkin’s lymphoma, Hodgkin’s 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.
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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-Hodgkin’s lymphoma. Cytokinetics’ unpartnered cardiovascular disease program is the second program to leverage the company’s 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 management’s 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:
  1.   All capitalized terms not defined herein shall have the meaning ascribed to them in the Collaboration Agreement.
 
  2.   Notwithstanding GSK’s 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.
 
  3.   The Research Plan for the extended Research Term is attached as Exhibit A hereto.
 
  4.   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.
 
***   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
  5.   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.
 
  6.   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
         
/s/ Paul Williamson
   
     
 
       
Name:
  Paul Williamson    
 
       
 
       
Title:
  For and on behalf of EdinBurgh Pharmaceutical Industries Limited
Corporate Director
 
       
     
cc:
  SVP WW Business Development, GlaxoSmithKline
 
  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
[***]

Page 3 of 3

 
***   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.