xoma8k_021909.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):  February 19, 2009
 
XOMA LTD.
(Exact name of registrant as specified in its charter)
 
BERMUDA
(State or other jurisdiction of incorporation)
 
0-14710
  
52-2154066
(Commission File Number)
  
(IRS Employer Identification No.)

2910 Seventh Street, Berkeley, California
94710
(Address of principal executive offices)
(Zip code)

Registrant's telephone number, including area code
  
(510) 204-7200

 
(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 8.01.                      Other Events
 
On February 19, 2009, the European Medicines Agency (the “EMEA”) announced it has recommended suspension of the marketing authorisation of RAPTIVA® (efalizumab) in the European Union.  The EMEA’s press release is attached as Exhibit 1 hereto and incorporated by reference herein.
 
Also on February 19, 2009, the U.S. Food and Drug Administration (the “FDA”) issued a public health advisory concerning three confirmed reports, and one possible report, of progressive multifocal leukoencephalopathy, or PML, in patients using RAPTIVA®.  The FDA’s news release is attached as Exhibit 2 hereto and incorporated by reference herein.

XOMA Ltd. currently receives royalties on worldwide sales of RAPTIVA®, a humanized therapeutic monoclonal antibody approved for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.  RAPTIVA® is marketed by Genentech Inc. in the United States and by Merck Serono S.A. outside the United States.

Item 9.01.                      Financial Statements and Exhibits.

 
1.
Press Release issued by the European Medicines Agency dated February 19, 2009
 
 
2.
News Release issued by the U.S. Food and Drug Administration dated February 19, 2009
 

 
 
 

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:  February 19, 2009
XOMA LTD.
   
   
 
By:  /s/ Fred Kurland    
 
        Fred Kurland
 
        Vice President, Finance and Chief
        Financial Officer

 
 
 

EXHIBIT INDEX
 
Number                      Description
 
1.
Press Release issued by the European Medicines Agency dated February 19, 2009
 
2.
News Release issued by the U.S. Food and Drug Administration dated February 19, 2009