elan6k_121508.htm


UNITED STATES
 
SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C.  20549
 

 
FORM 6-K
 

 
Report of Foreign Private Issuer
 
Pursuant to Rule 13a-16 or 15d-16
 
under the Securities Exchange Act of 1934
 

 
For the month of December, 2008.
 

 
Commission File Number 001-13896
 
Elan Corporation, plc
(Translation of registrant's name into English)

Treasury Building, Lower Grand Canal Street, Dublin 2, Ireland
(Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
 
Form 20-F
   x
  Form 40-F  o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Yes
   o
No  x
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
 
Yes
   o
No  x
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
 
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes
   o
No  x
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):
 

 
 
 

This Report of Foreign Issuer on Form 6-K is incorporated by reference into the Post-Effective Amendments on Forms F-3 and S-8 to Form F-4 Registration Statement of Elan Corporation, plc (Registration No. 333-12756), the Registration Statement on Form F-3 of Elan Corporation, plc and Athena Neuroscience Finance, LLC (Registration 333-13130), and the Registration Statements on Form S-8 of Elan Corporation, plc (Registration Nos. 333-13996, 333-12344, 333-11940, 333-100556, 333-09644, 333-09284, 333-09048, 333-08384, 333-07361, 333-07136, 333-14240, 333-121021, 333-135184 and 333-135185.


 
 
 


 
 

 
On December 11, 2008, relevant regulatory agencies were notified of a confirmed case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis (MS) patient treated with TYSABRI in the commercial setting in the European Union as part of TYGRIS:  TYSABRI® Global Observational Program in Safety - ROW.  Additional information about this case is set forth below.
 

 
·  
The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.

·  
Background:
-  
Patient has a history of MS and prior disease modifying therapies, including beta-interferons;
-  
Patient received approximately 26 months of TYSABRI monotherapy;
-  
Clinical vigilance led to early identification of signs and symptoms of possible PML and clinical evaluation which included MRI scanning and CSF testing;
-  
Patient is under the care of patient’s treating physician.

 




 
 
 

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, thereunto duly authorized.
 
ELAN CORPORATION, plc
 
By:    /s/ William F. Daniel             
William F. Daniel
    EVP, Company Secretary
  

Date: December 15, 2008