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EX-99.1 - IMBRUVICA? (IBRUTINIB) NOW APPROVED IN EUROPE FOR TREATMENT OF TWO BLOOD CANCERS - PHARMACYCLICS INCex99-1.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): October 17, 2014
 
PHARMACYCLICS, INC.
(Exact Name of Registrant as specified in Charter)
 
Delaware
000-26658
94-3148201
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
 
995 E. Arques Avenue, Sunnyvale, California
94085-4521
(Address of Principal Executive Offices)
(Zip Code)
 
Registrant’s telephone number, including area code: (408) 774-0330
 
 
(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 (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.
 
On October 17, 2014, Pharmacyclics, Inc. (the “Company”) earned an $80 million milestone payment under its collaboration agreement with Janssen Biotech Inc. as a result of the European Commission (“EC”) granting marketing approval for IMBRUVICA® (ibrutinib) throughout the 28 member states of the European Union (“EU”).  IMBRUVICA, a first-in-class, oral, once-daily, non-chemotherapy treatment, now is approved to be marketed in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (“CLL”) who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.  A copy of the press release announcing the EC approval is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information contained on the websites referenced in the press release is not incorporated herein.
 

Item 9.01
Financial Statements and Exhibits.
 
(d)    Exhibits.
 
Exhibit No.
 
Description
99.1
 
IMBRUVICA® (ibrutinib) Now Approved in Europe for Treatment of Two Blood Cancers
 

 
 

 

SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
 
October 20, 2014
 
 
PHARMACYCLICS, INC.
   
By:  
/s/ Manmeet Soni
 
Name:  Manmeet Soni
 
Title:    Chief Financial Officer

 
 

 
 
EXHIBIT INDEX
 
Exhibit No.
 
Description
99.1
 
IMBRUVICA® (ibrutinib) Now Approved in Europe for Treatment of Two Blood Cancers