0000914121-13-000557.txt : 20130904 0000914121-13-000557.hdr.sgml : 20130904 20130904164506 ACCESSION NUMBER: 0000914121-13-000557 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130904 FILED AS OF DATE: 20130904 DATE AS OF CHANGE: 20130904 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: 131078359 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 el20130903-6k.htm REPORT OF FOREIGN PRIVATE ISSUER el20130903-6k.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 September, 2013.
 
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):  _____
 
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):  _____
 
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 the Registration Statement on Form F-3 of Elan Corporation, plc (Registration No. 333-100252), and the Registration Statements on Form S-8 of Elan Corporation, plc (Registration Nos. 333-100556, 333-07361, 333-121021, 333-135184, 333-135185, 333-154573, 333-181971 and 333-181973).
 
 
 

 
 
-2- 

 


 
EXHIBIT LIST
 
                      
Exhibit
 
99.1
Description
 
Press release dated September 3, 2013 titled:
“Elan Announces Dosing of First Patient in Phase 2a Trial of ELND005 (Scyllo-inositol) in Down Syndrome”
 
 
 
 
 
 

 


 
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  
    Name:  William F. Daniel   
    Title:    Executive Vice President and Company Secretary  
       
 
 
Dated:  September 4, 2013
 
 
 
 
 

EX-99.1 2 el20130903-ex99_1.htm PRESS RELEASE el20130903-ex99_1.htm
 
Exhibit 99.1
 
 

 


Investor Relations:
Media Relations
Chris Burns
Ph: + 1-800-252-3526
David Marshall
Ph:+ 353-1-709-4444
 
 
 
Emer Reynolds
Ph: + 353-1-709-4022
Jonathan Birt
Ph: +44-786-036-1746
Jamie Tully
Ph: +1-212-687-8080
 

 
Elan Announces Dosing of First Patient in Phase 2a Trial of ELND005
(Scyllo-inositol) in Down Syndrome
 

 

DUBLIN, IRELAND, September 3, 2013 -- Elan Corporation, plc (NYSE: ELN) announced today the first patient dosing in a Phase 2a study of ELND005 in Down syndrome. Study ELND005-DS201 will evaluate the safety and pharmacokinetics of 2 doses of ELND005 and placebo in young adults with Down syndrome without dementia, and will also include select cognitive and behavioural measures. Information on the study design and protocol for ELND005-DS201 can be found at http://clinicaltrials.gov/.

The first person was dosed at the site of Dr. Ira Lott, Professor of Neurology and Pediatrics and Down syndrome expert at the University of California, Irvine. Dr Lott commented, “we are pleased to be starting this new study with ELND005. Drug development efforts in the field have been limited so far, and we look forward to studying the potential of ELND005 as a cognitive enhancer that may improve everyday functioning of adults with Down syndrome."

About Down Syndrome
Down syndrome (DS, Trisomy 21), caused by an extra copy of chromosome 21, is the most common genetic form of intellectual disability with a prevalence of approximately 1 in 700 live births in the US. Children with DS exhibit developmental delay and various degrees of intellectual disability, while adults are at increased risk of Alzheimer’s dementia. There are currently no drugs approved for the treatment of cognitive dysfunction in DS.
 
 
 
 
 

 
 
 
 

 
Excess activity of genes on chromosome 21, such as amyloid precursor protein (APP) and sodium-myo-inositol active transporter (SMIT), are thought to play a role in the cognitive dysfunction of DS. Life-long exposure to increased amyloid and myo-inositol levels in the brain are thought to lead to synaptic dysfunction and cognitive disability. ELND005 may have the potential to improve cognition in DS by decreasing amyloid levels and regulating myo-inositol-dependent neuronal signalling.

About ELND005
ELND005 is an orally bioavailable small molecule that is being investigated by Elan for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels.  An extensive clinical program of Phase 1 and Phase 2 studies have been completed with ELND005 to support clinical development, including the published Phase 2 study ELND005-AD201 in AD. ELND005 is also being studied as a potential treatment of agitation and aggression in Alzheimer’s disease (Study ELND005-AG201) and as a maintenance therapy of Bipolar Disorder Type I (Study ELND005-BPD201).

About Elan
Elan is a biotechnology company, headquartered in Ireland, 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. For additional information about Elan, please visit http://www.elan.com.



###
 
 
 
 

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