Form 8-K AVEO PHARMACEUTICALS For: Nov 10

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section�13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November�10, 2014

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AVEO Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

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Delaware	�	001-34655	�	04-3581650
(State or Other Jurisdiction of Incorporation)	�	(Commission File Number)	�	(IRS Employer Identification No.)

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650 East Kendall Street Cambridge, Massachusetts	�	02142
(Address of Principal Executive Offices)	�	(Zip Code)

Registrant�s telephone number, including area code: (617)�299-5000

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(Former Name or Former Address, if Changed Since Last Report)

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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):

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�	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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�	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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�	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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�	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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1.01	Entry into Definitive Material Agreement

On November�10, 2014 (the �Effective Date�), AVEO Pharmaceuticals, Inc., a Delaware corporation (�AVEO�), entered into a Research and Exclusive Option Agreement (the �Option Agreement�) with Ophthotech Corporation, a Delaware corporation (�Ophthotech�), pursuant to which AVEO has provided Ophthotech an exclusive option to enter into a definitive license agreement (the �Option�) under which AVEO would grant Ophthotech the right to develop and commercialize AVEO�s small molecule vascular endothelial growth factor tyrosine kinase inhibitor, tivozanib, outside of Asia for the potential diagnosis, prevention and treatment of non-oncologic diseases or conditions of the eye in humans.

AVEO has granted to Ophthotech an exclusive, royalty free license or sublicense, as applicable, under intellectual property rights controlled by AVEO solely to perform the research and development activities related to the use of tivozanib as set forth in the development plan during the Option Period (as defined below). These activities include formulation work for ocular administration, preclinical research and the conduct of a Phase 1/2a, proof of concept clinical trial of a product containing tivozanib in patients with wet age-related macular degeneration (the �POC Study�).

Ophthotech is required to pay AVEO a fee of $500,000 within ten days of the Effective Date in consideration for the grant of the Option. AVEO is obligated to make available to Ophthotech, at no cost to Ophthotech, certain quantities of tivozanib hydrochloride including manufacturing additional quantities of tivozanib in the event stability data indicates that the current supply will expire prior to the end of February 2017.

During the Option Period, if Ophthotech elects to continue the development of tivozanib for non-oncologic diseases of the eye, AVEO is entitled to receive $2 million upon acceptance of the first Investigational New Drug application for the purpose of conducting a human clinical study of tivozanib in ocular diseases (the �IND Submission Milestone Payment�). AVEO is also entitled to receive $6 million (the �Clinical Efficacy Milestone Payment�) on the earlier of (a)�December�31, 2016 and (b)�the later to occur of: (i)�the achievement of a clinical milestone in the POC Study (the �Clinical Efficacy Milestone�) and (ii)�the earlier of (A)�the date twelve (12)�months after the Parties� agreement as to the form and substance of the KHK Amendment (as defined below) or (B)�the date ninety (90)�days after the entry into the KHK Amendment, subject to Ophthotech�s right to terminate the Option Agreement on 90�days� written notice (the date on which such payment is due, the �Clinical Efficacy Milestone Payment Trigger Date�).

Ophthotech may exercise the Option at any time until the latest to occur of: (i)�twelve (12)�months after the achievement of the Clinical Efficacy Milestone, (ii)�ninety (90)�days after the Clinical Efficacy Milestone Payment Trigger Date, and (iii)�thirty (30)�days after AVEO and Ophthotech agree as to the definitive form of license agreement (the �Option Period�).

During the Option Period, AVEO will not grant a license to any third party that would preclude AVEO from being able to grant to Ophthotech the rights and licenses that are contemplated by the definitive license agreement, and AVEO will not engage in any research, development or commercialization of tivozanib in the field covered by the contemplated definitive license agreement, except as specified in the Option Agreement.

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The terms of the Option Agreement are subject to AVEO�s obligations to Kyowa Hakko Kirin (�KHK�) under a license agreement entered into by AVEO with KHK in 2006, pursuant to which AVEO acquired exclusive rights to develop and commercialize tivozanib for all human diseases outside of Asia (the �KHK License Agreement�). A percentage of all payments received by AVEO under the Option Agreement and any definitive license agreement must be paid to KHK. AVEO is required to maintain the KHK Agreement in effect, and not enter into any amendment or termination thereof that would adversely affect Opthotech�s rights, during the Option Period.

During the Option Period, AVEO and Ophthotech are obligated to negotiate in good faith the form and substance of a definitive license agreement, as well as the form and substance of an amendment to the KHK License Agreement (the �KHK Amendment�), to modify certain rights and obligations of the parties and sublicensees thereunder, particularly with respect to rights to improvements that are not specifically related to tivozanib, and regulatory affairs matters.

Upon exercise of the Option, Ophthotech is required to pay AVEO a fee of $2 million in addition to the IND Submission Milestone Payment if such payment has not then been previously paid. If upon exercise of the Option, the Clinical Efficacy Milestone Payment Trigger Date has not yet occurred, AVEO shall be entitled to the Clinical Efficacy Milestone Payment at such time that the Clinical Efficacy Milestone Payment Date does occur if the license agreement remains in effect as of such date. The license agreement, if entered into upon Ophthotech�s exercise of the Option, will provide for AVEO to be entitled to receive (i)�$10 million upon meeting certain efficacy and safety endpoints in phase 2 clinical trials that would enable the commencement of a phase�3 clinical trial, (ii)�$20 million upon marketing approval in the United States, (iii)�$20 million upon marketing approval in the UK, Germany, Spain, Italy and France and (iv)�up to $45 million in sales-based milestone payments. Ophthotech would also be required to pay tiered, double digit royalties, up to the mid-teens, on net sales of tivozanib or products containing tivozanib.

Either party may terminate the Option Agreement in the event of an uncured material breach of the Option Agreement by the other party which remains uncured for a period of ninety (90)�days (or thirty (30)�days for a breach relating to non-payment), or upon bankruptcy or like proceedings relating to the other party. Ophthotech may terminate the Option Agreement at any time upon ninety (90)�days� prior written notice to AVEO. In addition, AVEO may terminate the Option Agreement upon thirty (30)�days� prior written notice to Ophthotech if Ophthotech challenges certain patents controlled by AVEO related to tivozanib. Unless terminated as provided above, the Option Agreement will expire upon the expiration of the Option Period or the entry into the definitive license agreement.

The foregoing summary of the Option Agreement does not purport to be complete and is qualified in its entirety by the full text of the Option Agreement, which AVEO intends to file as an exhibit to its future filings with the Securities and Exchange Commission.

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Item�8.01 Other Events

On November�11, 2014, AVEO issued a press release announcing its entry into the Option Agreement described in Item�1.01 above. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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Item�9.01

Financial Statements and Exhibits.

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(d)

The following exhibits are included in this report:

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Exhibit No.	��	Description
99.1	��	Press Release dated November 11, 2014.

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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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AVEO Pharmaceuticals, Inc.
Date: November 11, 2014
By:	�	/s/ Tuan Ha-Ngoc
	�	Tuan Ha-Ngoc
	�	President and Chief Executive Officer

Exhibit 99.1

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AVEO Enters into Research and Exclusive Option Agreement with Ophthotech for

Tivozanib (VEGF inhibitor) for the Treatment of Ocular Diseases

CAMBRIDGE, Mass.�NOV 11, 2014�AVEO Oncology (NASDAQ: AVEO) today announced that it has entered into a research and exclusive option agreement with Ophthotech Corporation, under which it has provided Ophthotech an exclusive license to investigate the potential of AVEO�s small molecule vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor, tivozanib, outside of Asia for the potential treatment of non-oncologic diseases of the eye.

Under the terms of the agreement, Ophthotech is obligated to pay AVEO an upfront option fee of $500,000 to investigate tivozanib as a potential treatment for non-oncologic diseases of the eye. During the option term, if Ophthotech elects to continue development of the ocular formulation of tivozanib after its initial analysis, AVEO is eligible to receive up to $8 million in milestone payments based upon the achievement of specified research, development and business goals. Ophthotech has the exclusive option, exercisable at its sole discretion, to obtain additional development and commercialization rights to tivozanib and products containing tivozanib for non-oncologic eye indications in territories outside Asia, subject to certain conditions, including outcomes of a proof of concept clinical trial and the negotiation of a definitive license agreement.

If Ophthotech exercises its option, AVEO would receive an option exercise fee of $2 million and could also receive clinical and regulatory-based milestone payments, of up to $50 million, sales based milestone payments of up to $45 million and royalties on product sales. Ophthotech is responsible for all research and development activities and costs, and upon exercise of its option, further development and commercialization activities and costs for tivozanib ocular indications. A percentage of all upfront, milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

�This agreement is another example of our execution against AVEO�s key strategic objective of advancing our pipeline assets through external resources and expertise,� stated Tuan Ha-Ngoc, president and chief executive officer of AVEO. �We believe the unique properties of tivozanib make it an ideal VEGF inhibitor for potential ocular use, and we are encouraged by Ophthotech�s interest in exploring this potential. This agreement could enable us to realize value for tivozanib in an indication outside of cancer, while retaining oncology rights for further development through additional potential partnerships.�

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to discovering and developing targeted therapies designed to provide substantial impact in the lives of people with cancer by addressing unmet medical needs. AVEO�s proprietary Human Response Platform^� provides the company unique insights into cancer and related disease biology and is being leveraged in the discovery and clinical development of its therapeutic candidates. For more information, please visit the company�s website at www.aveooncology.com.

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Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words �anticipate,� �believe,� �estimate,� �expect,� �intend,� �may,� �plan,� �target,� �potential,� �could,� �should,� �seek,� or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about payments that may be received by AVEO under both the option agreement and any future license agreement with Ophthotech, the potential development of tivozanib in ocular diseases, the potential for AVEO to realize value for tivozanib in an indication outside of cancer and to further develop tivozanib in cancer indications through additional partnerships. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: Ophthotech�s ability and willingness to successfully develop tivozanib in non-oncologic diseases of the eye, including the risk that Ophthotech does not elect to exercise its option to enter into a license agreement with AVEO to further develop tivozanib in this indication; AVEO�s ability to execute on its business strategy and enter into and maintain new strategic partnerships and collaboration agreements; AVEO�s ability to successfully enroll and complete clinical trials and preclinical studies of its product candidates; AVEO�s ability to demonstrate to the satisfaction of the FDA, or equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO�s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO�s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO�s ongoing shareholder litigation and SEC inquiry; AVEO�s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled �Risk Factors� included in AVEO�s most recent Quarterly Report on Form 10-Q and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO�s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO�s views as of any date subsequent to the date of this press release.

Company, Media and Investor Contact:

David Pitts, Argot Partners

(212) 600-1902

[email protected]

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