0001104659-15-001643.txt : 20150112 0001104659-15-001643.hdr.sgml : 20150112 20150109195310 ACCESSION NUMBER: 0001104659-15-001643 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20150109 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150112 DATE AS OF CHANGE: 20150109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INCYTE CORP CENTRAL INDEX KEY: 0000879169 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 943136539 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12400 FILM NUMBER: 15520334 BUSINESS ADDRESS: STREET 1: 1801 AUGUSTINE CUT-OFF CITY: WILMINGTON STATE: DE ZIP: 19803 BUSINESS PHONE: 3024986700 MAIL ADDRESS: STREET 1: 1801 AUGUSTINE CUT-OFF CITY: WILMINGTON STATE: DE ZIP: 19803 FORMER COMPANY: FORMER CONFORMED NAME: INCYTE CORP DATE OF NAME CHANGE: 20030318 FORMER COMPANY: FORMER CONFORMED NAME: INCYTE GENOMICS INC DATE OF NAME CHANGE: 20000710 FORMER COMPANY: FORMER CONFORMED NAME: INCYTE PHARMACEUTICALS INC DATE OF NAME CHANGE: 19930902 8-K 1 a14-26360_38k.htm 8-K

 

 

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):  January 9, 2015

 

INCYTE CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware
(State or Other Jurisdiction of
Incorporation)

 

0-27488
(Commission File Number)

 

94-3136539
(I.R.S. Employer
Identification No.)

 

1801 Augustine Cut-Off

 

 

Wilmington, DE

 

19803

(Address of principal executive offices)

 

(Zip Code)

 

(302) 498-6700

(Registrant’s telephone number,
including area code)

 

N/A

(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 obligations 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))

 

 

 



 

Item 1.01                                           Entry into a Material Definitive Agreement.

 

On January 9, 2015, Incyte Corporation and a wholly-owned subsidiary thereof (collectively, the “Company”) entered into a License, Development and Commercialization Agreement (the “Collaboration Agreement”) with Agenus Inc. and its wholly-owned subsidiary, 4-Antibody AG (together, “Agenus”).  Under the Collaboration Agreement, the parties have agreed to collaborate on the discovery of novel immuno-therapeutics using Agenus’ proprietary Retrocyte Display™ antibody discovery platform.

 

Under the terms of the Collaboration Agreement, the Company received exclusive worldwide development and commercialization rights to four checkpoint modulators directed against GITR, OX40, LAG-3 and TIM-3. In addition to the initial four program targets, the Company and Agenus have the option to jointly nominate and pursue additional targets within the framework of the collaboration.  These targets may be designated profit-share programs, where all costs and profits are shared equally by the Company and Agenus, or royalty-bearing programs, where the Company will be responsible for all costs associated with discovery, preclinical activities, clinical development and commercialization activities. The programs relating to GITR and OX40 are profit-share programs and the programs relating to LAG-3 and TIM-3 are royalty-bearing programs.  All costs related to the collaboration are subject to a joint research plan.  The Company has agreed to pay Agenus upfront non-refundable payments totaling $25 million.  For each royalty-bearing product, Agenus will be eligible to receive up to $155 million in future contingent development, regulatory and commercialization milestones as well as tiered royalties on global net sales ranging from mid-single to low-double digit rates.  For each profit-share product, Agenus will be eligible to receive up to $20 million in future contingent development milestones.  Additionally, Agenus retains co-promotion participation rights in the United States on any profit-share product.  For each royalty-bearing product, Agenus has reserved the right to elect to co-fund 30% of development costs for a commensurate increase in royalties.  The Collaboration Agreement may be terminated by the Company for convenience and may also be terminated under certain other circumstances, including material breach, as set forth in the Collaboration Agreement.  Under the Collaboration Agreement, the Company has agreed to certain standstill provisions that allow the Company to acquire up to 15% of Agenus Inc.’s outstanding voting stock, including shares acquired pursuant to the Stock Purchase Agreement described below, solely for investment purposes.

 

In addition, the Company entered into a Stock Purchase Agreement with Agenus Inc. (the “Stock Purchase Agreement” and, together with the Collaboration Agreement, the “Agreements”), pursuant to which the Company agreed to purchase approximately 7.76 million shares of Agenus Inc. common stock (the “Shares”) for an aggregate purchase price of $35 million in cash, or approximately $4.51 per share.  The Company will own approximately 11% of the outstanding shares of Agenus Inc. common stock after such purchase.  Under the Stock Purchase Agreement, the Company has agreed not to dispose of any of the Shares for a period of 12 months and Agenus Inc. has agreed to certain registration rights with respect to the Shares.  Closing under the Stock Purchase Agreement is subject to customary conditions, as well as continued effectiveness of the Collaboration Agreement and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”).

 

The effectiveness of the Collaboration Agreement is conditioned on the expiration of the waiting period under the HSR Act.

 

A copy of the press release dated January 9, 2015 relating to the Agreements is attached hereto as Exhibit 99.1.

 

Item 9.01               Financial Statements and Exhibits.

 

(d)                                 Exhibits

 

99.1                        Press release issued by Incyte Corporation and Agenus Inc. dated January 9, 2015.

 

1



 

SIGNATURE

 

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.

 

Dated:  January 9, 2015

 

 

INCYTE CORPORATION

 

 

 

 

 

 

By:

/s/ Eric H. Siegel

 

 

Eric H. Siegel

 

 

Executive Vice President and

 

 

General Counsel

 

2


EX-99.1 2 a14-26360_3ex99d1.htm EX-99.1

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

Incyte and Agenus Announce Global Alliance to Develop
Novel Immuno-Oncology Antibodies

 

·                  Alliance to initially focus on four checkpoint modulator programs directed at GITR, OX40, TIM-3 and LAG-3

 

·                  Incyte to have access to Agenus’ proprietary Retrocyte Display™ platform for the discovery of additional therapeutic antibodies

 

·                  Agenus to receive $60 million comprised of a $25 million technology and program access fee under the collaboration plus $35 million equity investment in Agenus at $4.51/share

 

·                  Agenus eligible to receive up to $350 million in development, regulatory and commercial milestones across the four lead programs

 

WILMINGTON, DE and LEXINGTON, MA — January 9, 2015 — Incyte Corporation (Nasdaq: INCY) and Agenus Inc. (Nasdaq: AGEN) today announced a global license, development and commercialization agreement focused on novel immuno-therapeutics using Agenus’ proprietary Retrocyte Display antibody discovery platform.

 

The alliance will initially focus on the development of checkpoint modulator antibodies directed against GITR, OX40, LAG-3 and TIM-3. Agenus and Incyte will share all costs and profits for the GITR and OX40 antibody programs on a 50:50 basis, with Agenus eligible for potential milestones; TIM-3 and LAG-3 are royalty-bearing programs to be funded by Incyte, with Agenus eligible for potential milestones and royalties. The first clinical trials are expected to be initiated in 2016.

 

“This alliance with Agenus adds therapeutic antibody capabilities to our proven small molecule discovery expertise, significantly expands the landscape of potential immuno-oncology targets available to us, and strengthens our ability to identify and advance novel therapeutic combinations,” said Hervé Hoppenot, President and CEO of Incyte.

 

“Incyte’s track record of success in oncology development and commercialization, together with our therapeutic antibody expertise and the commonality of our objectives, speak to the compelling strategic rationale for this alliance,” said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. “Our Retrocyte Display technology has produced high quality antibody candidates

 



 

and offers significant advantages over competing technologies. With Incyte, we believe we have an ideal partner to help define the evolving treatment paradigm of cancer immunotherapies.”

 

Under the terms of the agreements between the parties, Incyte will make upfront payments to Agenus totaling $25 million and invest $35 million by purchasing approximately 7.76 million newly issued shares of Agenus common stock at a price of $4.51 per share. In addition to the initial four target programs in the alliance, the parties have an option to jointly nominate and pursue additional targets within the framework of the multi-year collaboration. Terms also include:

 

·                  For each royalty-bearing product, Agenus will be eligible to receive up to $155 million in future contingent development, regulatory and commercialization milestones.

·                  Also for royalty-bearing products, Agenus will be eligible to receive tiered royalties on global net sales ranging from mid-single to low-double digit rates, and has reserved the right to elect to co-fund 30% of development costs for increased royalties.

·                  For products from any additional programs that the parties elect to bring into the collaboration, Agenus may opt to designate them as profit-share products.

·                  For each profit-share product, Agenus will be eligible to receive up to $20 million in future contingent development milestones.

 

Retrocyte Display is a proprietary retroviral technology that enables a highly diverse library (>1x109) of human IgG molecules to be displayed on the surface of B-lineage cells. This innovative cell-displayed expression platform permits the rapid generation of fully human and humanized therapeutic antibodies with high affinity and target specificity.

 

The closing of the transaction is conditioned on the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

 

About Incyte

 

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs, primarily for oncology.  For additional information on Incyte, please visit the Company’s website at www.incyte.com.

 

About Agenus

 

Agenus is an immuno-oncology company developing a portfolio of checkpoint modulators (CPMs), heat shock protein peptide-based vaccines and adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery engine Retrocyte DisplayTM is used to generate fully human and humanized therapeutic antibody drug candidates. The Retrocyte DisplayTM platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat shock protein-based vaccines for cancer and infectious disease have completed Phase 2 studies in glioblastoma multiforme, and in the

 



 

treatment of herpes simplex viral infection. The company’s QS-21 Stimulon® adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen Sciences Ireland UC and includes several vaccine candidates in Phase 2, as well as shingles and malaria vaccines which have successfully completed Phase 3 clinical trials. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

 

Incyte Forward-Looking Statements

 

Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to the initial focus of the alliance, the potential benefits of the alliance and the expectation that the first clinical trials under the alliance will be initiated in 2016, contain predictions and estimates and are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development, results of further research and development, unanticipated delays, other market or economic factors and technological advances, regulatory approval of the transaction and other risks detailed from time to time in Incyte’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Incyte disclaims any intent or obligation to update these forward-looking statements.

 

Agenus Forward-Looking Statements

 

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the initial focus of the alliance between Agenus and Incyte, the potential benefits of the alliance and the expectation that the first clinical trials under the alliance will be initiated in 2016. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others, regulatory approval of the transaction, unanticipated delays and other market or economic factors, as well as the factors described under the Risk Factors section of our most recently filed Quarterly Report on Form 10-Q with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

 

Incyte Contact:
Pamela M. Murphy

Vice President, Investor Relations & Corporate Communications

302/498 6944

 



 

Agenus Contact:

Media:

Brad Miles / BMC Communications

646/513-3125

bmiles@bmccommunications.com

 

Investors:

Andrea Rabney / Argot Partners

212/600-1902

andrea@argotpartners.com

 

# # #

 


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