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): | June 19, 2007 |
Cytokinetics, Incorporated
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 000-50633 | 94-3291317 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
280 East Grand Avenue, South San Francisco, California | 94080 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | (650) 624 - 3000 |
Not Applicable
______________________________________________
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:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On June 18, 2007, 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, 2007.
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 November 2006, the Company and GSK amended the Collaboration Agreement to provide the Company with the right to assume responsibility, at its expense, for all continued research, development and commercialization of inhibitors of kinesin spindle protein, including ispinesib (SB-715992) and SB-743921, and other mitotic kinesins, except for centromere-associated protein E ("CENP-E") which remains the subject of collaborative research efforts under the C
ollaboration Agreement. The Company’s development of ispinesib and SB-743921 is subject to GSK’s option to resume responsibility for the development and commercialization of either or both drug candidates during a defined period. 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, 2006, as filed with the Securities and Exchange Commission on March 12, 2007.
The June 18, 2007 amendment extends the research term under the Collaboration Agreement for an additional year through June 19, 2008, to facilitate continued research activities under an updated research plan focused towards the mitotic kinesin CENP-E. 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 as Exhibit 10.64, and is incorporated here
in by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following Exhibits are filed as part of this Current Report on Form 8-K:
Exhibit No. Description
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10.64* Letter Amendment to the Collaboration Agreement, dated June 18, 2007, 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.
99.1 Extension of Research Term Press Release, dated June 19, 2007.
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 | ||||
June 19, 2007 | By: |
/s/ Sharon Surrey-Barbari
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Name: Sharon Surrey-Barbari | ||||
Title: Senior Vice President, Finance and Chief Financial Officer |
Exhibit Index
Exhibit No. | Description | |
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10.64
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* Letter Amendment to the Collaboration Agreement, dated June 18, 2007, 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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99.1
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Extension of Research Term Press Release, dated June 19, 2007. |
CONFIDENTIAL
280 East Grand Avenue
South San Francisco, CA 94080
Tel (650) 624-3000 Fax (650) 624-3010
June 18, 2007
GlaxoSmithKline
2301 Renaissance Boulevard
Building #510
RN0420
King of Prussia, Pennsylvania |
19406 | |||
Attn: |
Scott Klesmer |
Director, Alliance Management
Re: Second 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), dated 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 further 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, 2007, as follows:
1. | All capitalized terms not defined herein shall have the meaning ascribed to them in the Collaboration Agreement. |
2. | 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 is hereby extended for an additional one-year period to expire on June 19, 2008 solely with respect to CENP-E to allow for the conduct of Research Program activities directed to CENP-E. In addition, the first two occurrences of June 19, 2007 in Section 5(a) of the Amendment to Collaboration and License Agreement between CK and GSK, dated November 27, 2006 (the November 2006 Amendment) are hereby changed to June 19, 2008. |
3. | For clarity, in light of the present extension, GSK may only extend its rights under Section 4.2.3 of the Collaboration Agreement and only with respect to CENP-E for a further [***]-year Extension Period under Section 4.2.2 of the Collaboration Agreement, as contemplated in Section 4.2.2(d) of the Collaboration Agreement and subject to the November 2006 Amendment, unless otherwise agreed by the Parties. |
*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
CONFIDENTIAL
4. | Except for the amendment of Section 5(a) of the November 2006 Amendment in the manner described in paragraph 2 above, the November 2006 Amendment is unaffected by this Letter Amendment. |
5. | The Research Plan for the extended Research Term is attached as Exhibit A hereto. |
6. | The Parties hereby agree that the number of JRC representatives shall be four (4) for each of GSK and CK. All other terms and conditions of Section 2.2(a) remain unchanged. GSK hereby notifies CK that its JRC representatives shall be those individuals identified in Exhibit B hereto; and CK hereby notifies GSK that its JRC representatives shall be those individuals identified in Exhibit B hereto. |
7. | Notwithstanding Section 2.8.1 of the Collaboration Agreement, GSK has no obligation to fund any CK FTEs during this extension of the Research Term for CENP-E. |
8. | 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. |
9. | 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 Amendment if you agree to the foregoing terms.
Sincerely,
/s/ Robert I. Blum
Robert I. Blum
President and Chief Executive Officer
Cytokinetics, Inc.
Agreed and accepted:
GLAXO GROUP LIMITED
/s/ Paul Blackburn
Name: Paul Blackburn
Title: Director
Page 2 of 5
CONFIDENTIAL
cc:
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SVP WW Business Development, GlaxoSmithKline Lisa A. DeMarco, Esq., Vice President & Associate General Counsel, GlaxoSmithKline, R&D Legal Operations |
Kenneth A. Clark, Esq., Wilson Sonsini Goodrich & Rosati Professional Corporation
Page 3 of 5
CONFIDENTIAL
Exhibit A
Research Plan *
[***]
Page 4 of 5
*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
CONFIDENTIAL
Exhibit B
JRC Members
[***]
Page 5 o5
*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Contacts:
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Scott R. Jordan (Media) Director, Corporate Development (650) 624-3000 |
Christopher S. Keenan (Investors) Director, Investor Relations (650) 624-3000 |
CYTOKINETICS ANNOUNCES SECOND EXTENSION
OF RESEARCH TERM UNDER COLLABORATION WITH GLAXOSMITHKLINE
South San Francisco, CA, June 19, 2007 Cytokinetics, Incorporated (Nasdaq: CYTK) announced that it has agreed to extend the research term under its strategic alliance with GlaxoSmithKline (GSK) to continue research activities focused towards the mitotic kinesin centromere-associated protein E (CENP-E). The strategic alliance, initiated in June 2001, included an initial five-year research term. In June 2006, Cytokinetics and GSK announced a one-year extension to the research collaboration focused to translational research directed towards CENP-E. The companies have now agreed to extend the research program for an additional year, during which each company, at its own expense, will continue to perform translational research in accordance with an agreed plan.
CENP-E is a mitotic kinesin directly involved in coupling the mechanics of mitosis with the mitotic checkpoint signaling machinery, thereby regulating cell proliferation. CENP-E is also essential for prometaphase chromosome movements that contribute to proper chromosome alignment. Both 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 again extend our collaborative research with GSK, stated David J. Morgans, Jr., Senior Vice President, Preclinical Research and Development, Cytokinetics. Translational research directed to CENP-E has informed the preclinical development activities for GSK-923295 and has positioned the compound for its expected movement into first-time-in-human clinical trials later this 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, which both target kinesin spindle protein (KSP), and one potential drug candidate in preclinical development, GSK-923295, which targets CENP-E In June 2006, Cytokinetics announced the extension of the research term of this strategic alliance for an additional year, beyond the original minimum of five years, to continue activities focused towards translational research directed to CENP-E. Under a November 2006 amendment to its collaboration and license agreement with GSK, Cytokinetics assumed responsibility for the costs and activities associated with the continued development of the KSP inhibitors ispinesib and SB-743921, subject to GSKs option to resume responsibility for some or all development and commercialization activities associated with each of these novel drug candidates. The November 2006 amendment superseded a September 2005 amendment to the collaboration and license agreement, which specifically related to SB-743921.
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 peripheral nervous system function. 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, 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.
About Cytokinetics
Cytokinetics is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that may address areas of significant unmet clinical needs. Cytokinetics development efforts are directed to advancing multiple drug candidates through clinical trials to demonstrate proof-of-concept in humans, specifically in the areas of heart failure and cancer. Cytokinetics cardiovascular disease program is focused to cardiac myosin, a motor protein essential to cardiac muscle contraction. Cytokinetics lead compound, CK-1827452, a novel small molecule cardiac myosin activator, recently entered Phase II clinical trials for the treatment of heart failure in 2007. Under a strategic alliance established in 2006, Cytokinetics and Amgen Inc. plan to conduct research with activators of cardiac myosin in order to identify potential treatments for patients with heart failure. Amgen has obtained an option for the joint development and commercialization of CK-1827452 exercisable during a defined period, the ending of which is dependent on Cytokinetics conduct of further clinical trials of CK-1827452. Cytokinetics cancer program is focused on mitotic kinesins, a family of motor proteins essential to cell division. Cytokinetics is developing two novel drug candidates that have arisen from this program, ispinesib and SB-743921, each a novel inhibitor of kinesin spindle protein (KSP), a mitotic kinesin. Ispinesib has been the subject of a broad clinical trials program comprised of nine Phase II clinical trials as well as six Phase I or Ib clinical trials. Cytokinetics plans to conduct additional clinical trials with ispinesib and is conducting a Phase I/II trial of SB-743921 in non-Hodgkins lymphoma. Under a strategic alliance established in 2001, Cytokinetics and GlaxoSmithKline (GSK) are conducting research and development activities focused on the potential treatment of cancer. GSK has obtained an option for the joint development and commercialization of ispinesib and SB-743921, exercisable during a defined period. Cytokinetics and GSK are conducting collaborative research activities directed to the mitotic kinesin centromere-associated protein E (CENP-E). GSK-923295, a CENP-E inhibitor, is being developed under the strategic alliance by GSK. GSK is expected to begin clinical trials with GSK-923295 in 2007. All of these drug candidates have arisen from Cytokinetics research activities and are directed towards 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, and cardiovascular disease. Additional information about Cytokinetics can be obtained at 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 the expected initiation, timing, scope and results of Cytokinetics and its partners research and development programs, including statements regarding initiation of clinical trials, the potential benefits of Cytokinetics drug candidates and potential drug candidates and the enabling capabilities of Cytokinetics biological focus Such statements are based on managements current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential decisions by GSK to postpone or discontinue development efforts for GSK-923295; potential difficulties or delays in the development, testing, regulatory approval, production and marketing of Cytokinetics drug candidates that could slow or prevent clinical development, product approval or market acceptance, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for clinical trials may be difficult or delayed, Cytokinetics drug candidates may have unexpected adverse side effects or inadequate therapeutic efficacy, and Cytokinetics may be unable to obtain and maintain patent or trade secret protection for its intellectual property; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing if necessary; standards of care may change or others may introduce products or alternative therapies for the treatment of indications Cytokinetics drug candidates and potential drug candidates currently or potentially target; and risks and uncertainties relating to the timing and receipt of funds under Cytokinetics 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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