-----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, DzIfuXk17z+B1j8Y9tnruNC8W5KsxeL6PYz2TrfO7vP609pfq1thw4N4BQIC52T3 Ldn5fOuwM7/EQi2v+5CL4A== 0000950162-09-000306.txt : 20090713 0000950162-09-000306.hdr.sgml : 20090713 20090713163239 ACCESSION NUMBER: 0000950162-09-000306 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20090713 FILED AS OF DATE: 20090713 DATE AS OF CHANGE: 20090713 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: 09942208 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_071309.htm ELANCORP6-K 071309 elan6k_071309.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 July 2009.
 
       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 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 and 333-154573).


 
 

 




EXHIBIT LIST

Exhibit
Description
   
99.1
Press release dated July 13, 2009 titled:
Elan and Transition Therapeutics Announce Phase 1 Data Showing ELND005 Achieves Desired Concentrations in Brain Tissue and Cerebrospinal Fluid.
   





 
 

 

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: July 13, 2009





 
EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm

 

 

ELAN AND TRANSITION THERAPEUTICS ANNOUNCE PHASE 1 DATA SHOWING ELND005 ACHIEVES DESIRED CONCENTRATIONS IN BRAIN TISSUE AND CEREBROSPINAL FLUID

Presentations at 2009 Alzheimer’s Association International Conference on Alzheimer’s Disease Support Ongoing Phase 2 Trial

Dublin, Ireland; Toronto, ON, and Vienna, Austria – July 13, 2009 – Elan Corporation, plc (NYSE: ELN) and Transition Therapeutics Inc. (TSX: TTH, NASDAQ: TTHI) today presented Phase 1 data demonstrating that treatment with ELND005 (scyllo-inositol formerly known as AZD-103), achieves desired concentrations in human brain tissue and cerebrospinal fluid when given orally. Preclinical data also were presented showing that ELND005 administration is associated with preservation of choline acetyltransferase (ChAT), reflecting preservation of nerve cells that are critical to memory function in the brain. ELND005 is an orally-administered drug candidate in Phase 2 trials for the treatment of mild to moderate Alzheimer’s disease. These results were presented at the 2009 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2009) in Vienna, Austria.

In a poster entitled, “Oral Amyloid Anti-aggregating Agent ELND005 is Measurable in CSF and Brain of Healthy Adult Men,” the researchers describe results of a Phase 1 study in which eight healthy adults each received 2,000 mg of ELND005 twice a day for 10 days. Concentrations of ELND005 in cerebrospinal fluid were measured directly, while brain tissue concentrations were measured non-invasively using a novel magnetic resonance spectroscopy technique and were determined to be within the range associated with efficacy in previous animal studies that employed a transgenic animal model of Alzheimer’s Disease. ELND005 was well tolerated by these study participants with no severe, serious, or treatment-limiting adverse events observed.

“Achieving a clinically beneficial concentration of drug in brain tissue and cerebrospinal fluid has presented a significant hurdle to other drugs investigated to treat Alzheimer’s Disease, so this is an important proof of concept for us,” said Elan president Carlos V. Paya, MD, PhD. “We look forward to completing and reporting results from our ongoing Phase 2 study of ELND005 in patients with mild to moderate Alzheimer's disease, which completed enrollment in October 2008.”

In a second poster, entitled “Quantification of Cholinergic Degradation and Adult Neurogenesis in TgCRND8 Mice Following Treatment with Scyllo-Inositol (ELND005),” Dr. JoAnne McLaurin and colleagues from the University of Toronto analyzed levels of the enzyme Choline Acetyltransferase (ChAT) in an animal model of Alzheimer’s disease. As in humans, these Alzheimer’s animal models exhibit damage to nerve cells in a region of the brain called the “basal forebrain” that use the neurotransmitter acetylcholine to transmit nerve impulses critical to memory functions to other nerve cells in a brain region important for memory function called the
1

 
hippocampus. Animals treated with ELND005 exhibited significantly more ChAT levels  compared to untreated animals.
 
“There is evidence that amyloid plaque formation drives the decline in memory and cognition associated with Alzheimer’s disease,” said JoAnne McLaurin, PhD, professor at the University of Toronto’s Centre for Research in Neurodegenerative Diseases. “Although more research is necessary, the findings presented today suggest that ELND005 may have the ability to prevent the loss of ChAT that results from damage to cholinergic neurons in the brain, thereby potentially protecting against cognitive decline in individuals with Alzheimer’s disease.”

“We have conducted a robust preclinical and Phase 1 research program of ELND005 that has demonstrated that the drug is able to cross the blood-brain barrier, which should allow it to target the disaggregation of amyloid beta in the brain,” said Dr. Tony Cruz, chairman and chief executive officer of Transition.

In 2006, Elan and Transition entered into an exclusive, worldwide collaboration agreement for the joint development and commercialization of ELND005 for the treatment of Alzheimer’s disease and other indications.
 
About ELND005 (AZD-103)
 
 
ELND005 is an orally-administered therapeutic agent that has received fast track designation from the U.S. Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer’s disease. Fast track designation can facilitate development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions.
 
 
ELND005 is currently in a Phase 2 clinical study, which completed enrollment in October 2008. The study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 340 patients with mild to moderate Alzheimer’s disease. The planned treatment period for each patient is approximately 18 months.
 
 
About Alzheimer’s Disease
 
 
Alzheimer’s disease, a leading cause of dementia, is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. Alzheimer’s disease may result from the build-up of toxic beta-amyloid peptides in the brain. As Alzheimer’s disease progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It is currently estimated that more than 5 million Americans have Alzheimer’s disease and more than 24 million people worldwide over the age of 60 have some form of dementia (Source: Alzheimer’s Association and Alzheimer’s Disease International).
 
 
2


 
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 http://www.elan.com.
 
 
About Transition
 
 
Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND005 for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates acquired externally and developed internally using its proprietary drug discovery engine. Transition's shares are listed on the NASDAQ under the symbol "TTHI" and the Toronto Stock Exchange under the symbol "TTH". For additional information about the Company, please visit www.transitiontherapeutics.com.
 
 
Safe Harbor/Forward-Looking Statements
 
This press release contains forward-looking statements regarding the development of scyllo-inositol (ELND005) under the collaboration agreement between Elan and Transition. These statements are based on Elan’s and Transition's current beliefs and expectations. ELND005 may not be successfully developed or commercialized under the collaboration agreement. Factors which could cause actual results to differ materially from Elan’s and Transition's current expectations include the risks that clinical development of ELND005 fails due to safety or efficacy issues, the results from Phase 1 clinical trials and preclinical testing of ELND005 are not predictive of results to be obtained in Phase 2 or later clinical trials, the patent issued with respect to ELND005 may not provide substantial protection or commercial benefit, the development and commercialization of competitive therapies, the collaboration agreement is terminated early or Elan and Transition encounter other unexpected delays or hurdles. Drug development and commercialization involves a high degree of risk.

For more detailed information on the risks and uncertainties associated with Elan and Transition's drug development and other activities, see the periodic and current reports that Elan has filed with the Securities and Exchange Commission and that Transition has filed with the Securities and Exchange Commission and the Ontario Securities Commission. Elan and Transition assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
 
 

Elan Contacts:
Transition Therapeutics Contacts:
MEDIA:
Miriam Mason
Phone: 650-278-7113
Miriam.Mason@elan.com
Mary Stutts
 
Dr. Tony Cruz
Chief Executive Officer
Phone: 416-260-7770, x.223
tcruz@transitiontherapeutics.com
 

 
 
 
3

 

 
 
 
 
Phone: 650-794-4403
Mary.Stutts@elan.com
 
Elie Farah
President & Chief Financial Officer
Phone: 416-260-7770, x.203
efarah@transitiontherapeutics.com
 
 
INVESTORS:
Chris Burns
Ph: 800-252-3526
Chris.Burns@elan.com
David Marshall
Phone: 353-1-709-4444
David.Marshall @elan.com
 
 
 
 
 
###

 
4
 


 
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