Form 8-K AVEO PHARMACEUTICALS For: Aug 13

 

 

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): August 13, 2015

 

 

AVEO Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

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

 

One Broadway, 14th Floor Cambridge, Massachusetts		02142
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 588-1960

 

 

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):

 

¨	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))

 

 

 

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Item 1.01 Entry into a Material Definitive Agreement.

Novartis License Agreement

On August 13, 2015 (the “Effective Date”), AVEO Pharmaceuticals, Inc. (“AVEO”), entered into a License Agreement (the “License Agreement”) with Novartis International Pharmaceutical Ltd., a Bermuda corporation (“Novartis”). Under the License Agreement, AVEO has granted to Novartis the exclusive right to develop and commercialize worldwide AVEO’s proprietary antibody AV-380 and related AVEO antibodies that bind to Growth Differentiation Factor 15 (“GDF15”) for the treatment and prevention of diseases and other conditions in all indications in humans.

Under the License Agreement, Novartis is required to make an upfront payment to AVEO of $15 million within fifteen days of the Effective Date. Novartis also has the right for 90 days after the Effective Date to acquire AVEO’s inventory of clinical quality, AV-380 biological drug substance. If Novartis exercises such right, it will reimburse AVEO up to $3.45 million for such existing inventory. AVEO will also be eligible to receive (a) up to $53 million in potential clinical milestone payments and up to $105 million in potential regulatory milestone payments tied to the commencement of clinical trials and to regulatory approvals of products developed under the License Agreement in the United States, the European Union and Japan; and (b) up to $150 million in potential sales based milestone payments based on annual net sales of such products. Upon commercialization, AVEO is eligible to receive tiered royalties on net sales of approved products ranging from the high single digits to the low double digits. Novartis has responsibility under the License Agreement for the development, manufacture and commercialization of the AVEO antibodies and any resulting approved therapeutic products.

The term of the License Agreement commenced on the Effective Date and will continue on a country-by-country basis until the later to occur of the 10^th anniversary of the first commercial sale of a product in such country or the expiration of the last valid patent claim for a product in that country. Either party may terminate the License Agreement in the event of a material breach of the License Agreement by the other party that remains uncured for a period of sixty (60) days, which period may be extended an additional thirty (30) days under certain circumstances. Novartis may terminate the License Agreement, either in its entirety or with respect to any individual products or countries, at any time upon sixty (60) days’ prior written notice. In addition, AVEO may terminate the License Agreement upon thirty (30) days’ prior written notice if Novartis challenges certain patents controlled by AVEO related to the AVEO antibodies.

AVEO has agreed that it will not directly or indirectly develop, manufacture or commercialize any GDF15 modulator as a human therapeutic during the term of the License Agreement.

Amended and Restated St. Vincent’s License Agreement

In order to sublicense certain necessary intellectual property rights to Novartis under the License Agreement, AVEO has entered into an Amended and Restated License Agreement with St. Vincent’s Hospital Sydney Limited (“St. Vincent’s”) on the Effective Date (the “Amended St. Vincent’s Agreement”), which amends and restates the original license agreement, dated July 2, 2012, between AVEO and St. Vincent’s. AVEO is required to make an upfront payment to St. Vincent’s of $1.5 million within 21 days of the Effective Date. St. Vincent’s is also eligible to receive up to approximately $18.9 million in connection with development and regulatory milestones under the Amended St. Vincent’s Agreement. Royalties for approved products resulting from the License Agreement will also be payable to St. Vincent’s, and AVEO and Novartis will share that obligation equally. Under the License Agreement with Novartis, AVEO is required to maintain the Amended St. Vincent’s Agreement in effect, and not enter into any amendment that would adversely affect Novartis’ rights during the term of the License Agreement.

The foregoing summary of the License Agreement and the Amended SVH Agreement does not purport to be complete and is qualified in its entirety by the full text of the License Agreement and the Amended SVH Agreement, each of 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 August 17, 2015, AVEO issued a press release announcing its entry into the License 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.

Item 9.01. Financial Statements and Exhibits.

 

(d)

Exhibits

 

99.1

Press Release issued by AVEO Pharmaceuticals, Inc. on August 17, 2015

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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.

 

AVEO Pharmaceuticals, Inc.
Date: August 17, 2015
By:		/s/ Michael Bailey
		Michael Bailey
		President and Chief Executive Officer

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release

Exhibit 99.1

 

AVEO Announces Exclusive Worldwide License Agreement for the Development and Commercialization of AV-380 and Related Antibodies

CAMBRIDGE, Mass. – August 17, 2015 – AVEO Oncology (NASDAQ: AVEO) today announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody (the “Product”).

Under the terms of the agreement, AVEO will receive an upfront payment of $15 million and will be eligible to receive reimbursement, clinical, sales and regulatory-based milestone payments totaling $311 million assuming successful advancement of the Product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs associated with the Product.

“AV-380 holds great promise as a potential treatment for cachexia secondary to multiple disease states, including cancer, chronic kidney disease, congestive heart failure and chronic obstructive pulmonary disease,” said Michael Bailey, AVEO’s president and chief executive officer. “Novartis brings resources and expertise to bear on advancing this program, which we believe provides the optimal path forward toward realizing its full potential.”

About Cachexia and GDF15

Cachexia is a complex metabolic syndrome associated with malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. Cachexia is a serious and common complication in patients with advanced cancer and other chronic diseases. It affects some five million individuals in the United States¹.

GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Current evidence suggests that a pro-inflammatory state may be responsible for many of the symptoms associated with cachexia. Preclinical data show that inhibition of GDF15 results in a switch from catabolism to anabolism, suggesting that GDF15 inhibition with AV-380 may reverse the effects of cachexia.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.

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AVEO 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 fact, contained in this press release are forward-looking statements. The words “anticipate,” “expect,” “intend,” “may,” “plan,” “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 the expected benefits of AVEO’s agreement with Novartis, the amount, timing and potential receipt of payments under the Novartis agreement and AVEO’s clinical development plans for tivozanib in renal cell and colorectal cancer. 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: AVEO’s ability to maintain its agreement with Novartis; AVEO’s ability, and the ability of any licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials 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” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and 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 may cause its views to change. 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 other than the date of this press release.

References

 

1	Morley et al. Cachexia: pathophysiology and clinical relevance. Am J Clin Nutr 2006;83:735–43.

Company, Media and Investor Contact:

David Pitts, Argot Partners

(212) 600-1902

[email protected]

 

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