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EX-99.1 - EX-99.1 - ENDOCYTE INCexhibit1.htm
 

 


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):   April 13, 2012

Endocyte, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 001-35050 35-1969-140
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
3000 Kent Avenue, Suite A1-100, West Lafayette, Indiana   47906
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   765-463-7175

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 April 13, 2012, Endocyte, Inc. (the “Company”) entered into a Collaboration, Exclusive License and Companion Diagnostic Agreement (the “Agreement”) with Merck Sharp & Dohme Research GmbH, a subsidiary of Merck & Co, Inc. (“Merck”), regarding the development and commercialization of the Company’s novel investigational therapeutic candidate, vintafolide (EC145). The Agreement grants Merck worldwide rights to develop and commercialize vintafolide. The Company will receive a $120 million upfront payment and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide in a total of six different cancer indications. In addition, following regulatory approval and launch of vintafolide, the Company will receive an equal share of the profit in the United States (U.S.) as well as a double-digit percentage royalty on sales of the product in the rest of the world. The Company has retained the right (which it can opt out of) to co-promote vintafolide with Merck in the U.S. and Merck has the exclusive right to promote vintafolide in the rest of the world. The Company will be responsible for the majority of funding and completion of the ongoing Phase III clinical trial of vintafolide for platinum-resistant ovarian cancer (the PROCEED trial). Merck will be responsible for all other development activities and costs and will have all decision rights with respect to the development and commercialation of vintafolide. The Company will remain responsible for the development, manufacture and commercialization worldwide of etarfolatide (EC20), an investigational non-invasive companion diagnostic imaging agent that is used to identify folate receptor positive tumor cells.

Closing of the transaction contemplated by the Agreement is contingent upon obtaining clearance from the Federal Trade Commission under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The foregoing is not a complete summary of all terms of the Agreement and is qualified in its entirety by the full text of the Agreement, which the Company intends to file as an exhibit to future periodic reports filed with the Securities and Exchange Commission.

On April 16, 2012, the Company issued a press release announcing that it had entered into the Agreement, a copy of which press release is attached to this Current Report as Exhibit 99.1 and incorporated herein by reference.

Certain of the statements made in this report are forward looking, such as those, among others, relating to the Company’s expectations for seeking regulatory approval and commercial launch of its products, including any conditional marketing authorization from the EMA, initiation of future clinical trials, and expectations for the receipt of milestones, royalties or other profits from the agreement. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the Company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, unavailability of Doxil, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the Company’s product candidates, the goals of its development activities, estimates of the potential markets for its product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected financial results. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the Company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

(d) Exhibits

         
Exhibit No.  
Description
       
 
  99.1    
Press release dated April 16, 2012


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.

         
    Endocyte, Inc.
          
April 19, 2012   By:   /s/ Michael A. Sherman
       
        Name: Michael A. Sherman
        Title: Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Exhibit 99.1 Press Release dated April 16, 2012