-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JjRUi3uCu9xvN058gTf3NzJP78br453GluRwCaY2Sv3h+eeZMmEnAXdyegHqf8vK jpwmrtU6nUg2rcmzucd/rg== 0000950162-06-000341.txt : 20060322 0000950162-06-000341.hdr.sgml : 20060322 20060322104302 ACCESSION NUMBER: 0000950162-06-000341 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060322 FILED AS OF DATE: 20060322 DATE AS OF CHANGE: 20060322 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ELAN CORP PLC CENTRAL INDEX KEY: 0000737572 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13896 FILM NUMBER: 06702730 BUSINESS ADDRESS: STREET 1: TREASURY BUILDING STREET 2: LOWER GRAND CANAL STREET CITY: DUBLIN 2 STATE: L2 ZIP: 00000 BUSINESS PHONE: 35317094000 MAIL ADDRESS: STREET 1: TREASURY BUILDING STREET 2: LOWER GRAND CANAL STREET CITY: DUBLIN 2 STATE: L2 ZIP: 00000 6-K 1 elan6k_032206.htm ELAN CORPORATION PLC - 6K - 03/22/06 Elan Corporation plc - 6K - 03/22/06
FORM 6-K
 
SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C. 20549
 
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
 
For the month of March, 2006
 
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
 
 
 
 

-2-
 
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 No. 333-13130), and the Registration Statements on Form S-8 of Elan Corporation, plc (Registration Nos. 333-13996, 333-12344, 333-11940, 333-09644, 333-09284, 333-09048, 333-08384, 333-07361, 333-07136, 333-14240, 33-27506, 333-100252 and 333-121021).
 



 
 

 



EXHIBIT LIST

 
Description
 
99.1
 
Press release dated March 22, 2006 titled:
Biogen Idec and Elan announce that FDA will extend regulatory review
period for the reintroduction of TYSABRI
® for multiple sclerosis.
 



 
 

 


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: March 22, 2006

 
EX-99.1 2 ex99_1.htm EXHIBIT 99.1 - PRESS RELEASE Exhibit 99.1 - Press Release
Exhibit 99.1


               

For More Information Contact:
MEDIA CONTACTS:
 
Biogen Idec
Amy Brockelman
Ph: 617 914 6524
Elan
Davia B. Temin
Ph: 212 407 5740
Elizabeth Headon
353-1-498-0300
INVESTOR CONTACTS:
 
Biogen Idec
Oscar Velastegui
Ph: 617 679 2812
Elan
Emer Reynolds
Ph: 353 1 709 4000
Chris Burns
800 252 3526


BIOGEN IDEC AND ELAN ANNOUNCE THAT FDA WILL EXTEND REGULATORY
REVIEW PERIOD FOR THE REINTRODUCTION OF TYSABRI
® FOR
MULTIPLE SCLEROSIS


Cambridge, MA and Dublin, Ireland - March 22, 2006 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that the U.S. Food and Drug Administration (FDA) informed the companies that the Agency will extend its regulatory review of TYSABRI® (natalizumab) as a treatment for multiple sclerosis by up to 90 days.

The companies have been informed by the FDA that the Agency requires additional time to review information regarding the TYSABRI risk management plan. Under this revised timeline, the companies anticipate action from FDA on or before June 28, 2006.
  
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.




-MORE-

 
 

 

Page 2    Biogen Idec And Elan Announce That FDA Will Extend Regulatory Review Period For The Reintroduction
Of TYSABRI® For Multiple Sclerosis

About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the potential and regulatory path forward of TYSABRI. The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies’ current expectations include the risk that we may unable to adequately address concerns or questions raised by FDA or European regulatory authorities during the regulatory review process, that concerns may arise from additional data or analysis, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies’ drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
###
 
 
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