0001104659-13-021427.txt : 20130318 0001104659-13-021427.hdr.sgml : 20130318 20130318074741 ACCESSION NUMBER: 0001104659-13-021427 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20130318 ITEM INFORMATION: Other Events FILED AS OF DATE: 20130318 DATE AS OF CHANGE: 20130318 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: 13696059 BUSINESS ADDRESS: STREET 1: ROUTE 141 & HENRY CLAY ROAD STREET 2: BUILDING E336 CITY: WILMINGTON STATE: DE ZIP: 19880 BUSINESS PHONE: 3024986700 MAIL ADDRESS: STREET 1: ROUTE 141 & HENRY CLAY ROAD STREET 2: BUILDING E336 CITY: WILMINGTON STATE: DE ZIP: 19880 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 a13-7759_18k.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):  March 18, 2013

 

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.)

 

Experimental Station

 

 

Route 141 & Henry Clay Road

 

 

Building E336

 

 

Wilmington, DE

 

19880

(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 8.01                                           Other Events.

 

Incyte Corporation (the “Company”) was informed last week of a case of progressive multifocal leukoencephalopathy (“PML”) in a 75 year old male patient from the United Kingdom with myelofibrosis treated with ruxolitinib.  Ruxolitinib is marketed by the Company as Jakafi® in the United States and by Novartis as Jakavi® outside the United States.  It has not been determined whether development of PML in this case was related to the use of ruxolitinib.  An independent assessment to confirm the diagnosis and evaluate the causality assessment provided by the investigator is planned.  This is the only known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product.  Jakafi is approved in the United States for the treatment of patients with intermediate or high-risk myelofibrosis (“MF”), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.  The Company has informed the U.S. Food and Drug Administration of this case and, as part of its standard procedure for sharing available information in a timely manner, is in the process of informing investigators in its clinical trials.  There are reports in the medical literature that suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML.

 

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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:  March 18, 2013

 

 

INCYTE CORPORATION

 

 

 

 

 

By:

/s/ Eric H. Siegel

 

 

Eric H. Siegel

 

 

Executive Vice President and

 

 

General Counsel

 

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