-----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, D91ud36MZ4Z5xZFS1sHWv4cFcbok19W+1a8l7LUjw9WWG0MfX3VIJzA8I1Chbuy6 ccayXf2i3Xhc7NUfK5LkUw== 0000950162-07-000628.txt : 20071029 0000950162-07-000628.hdr.sgml : 20071029 20071029112438 ACCESSION NUMBER: 0000950162-07-000628 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071029 FILED AS OF DATE: 20071029 DATE AS OF CHANGE: 20071029 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: 071195403 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_102907.htm ELAN CORP. 6K - 10/29/07 elan6k_102907.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 October, 2007
 
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 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

Exhibit
Description
   
99.1
Press release dated October 29, 2007 titled:
Elan announces the Johnson & Johnson Pharmaceutical Research & Development submission of a New Drug Application to the FDA for paliperidone palmitate using Elan’s proprietary Nanocrystal® Technology.




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: October 29, 2007

EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm
 
Exhibit 99.1
 
 
Final
30 October 2007

 
MEDIA CONTACTS:
INVESTOR CONTACT:
Jonathan Birt
212 850 5664
 
Elizabeth Headon
353 1 498 0300
Chris Burns
353 1 709 4444
800 252 3526
 

 
ELAN ANNOUNCES THE JOHNSON & JOHNSON PHARMACEUTICAL
RESEARCH & DEVELOPMENT SUBMISSION OF A NEW DRUG
APPLICATION TO THE FDA FOR PALIPERIDONE PALMITATE USING
ELAN’S PROPRIETARY NANOCRYSTAL® TECHNOLOGY

DUBLIN, Ireland – October 29, 2007– Elan Corporation, plc (NYSE:  ELN) today announced that Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia and the prevention of recurrence of the symptoms of schizophrenia. Paliperidone palmitate is a long acting injectable ester of the active ingredient in INVEGA™1 and utilizes Elan’s NanoCrystal® Technology.

Under the terms of Elan’s License Agreement, Elan is eligible to receive payments upon the achievement of certain milestones. Additionally, Elan will receive royalty payments based on sales of the injectable paliperidone palmitate formulation, if the product is successfully commercialized.

"We are very pleased to see this product application being filed with the US regulatory authorities.  If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories.  This is the first long acting injectable product developed and submitted to a Health Authority using Elan’s NanoCrystal® Technology and marks a significant milestone in the advancement of the technology," commented Shane Cooke, Chief Financial Officer and Head of Elan Drug Technologies.


 
1 INVEGA™ is a once-daily oral atypical antipsychotic for the treatment and maintenance of schizophrenia.  INVEGA was discovered and developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD), and is marketed in the U.S. by Janssen, L.P.

 
 

 

Final
30 October 2007
 
About NanoCrystal® Technology and Elan Drug Technologies
 
The use of Elan’s NanoCrystal® Technology increases the rate of dissolution of the poorly water soluble paliperidone palmitate compound and enables the formulation of an aqueous suspension for once-monthly administration. The technology, which can offer enhanced commercialization opportunities, is covered by numerous U.S. and foreign patents and is part of a suite of technologies which Elan's Drug Technologies business offers to third party clients. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, and sterile forms for injection, with the potential for substantial improvements to clinical performance.
 
Currently four products marketed in the United States/Internationally utilize Elan's NanoCrystal® Technology:  TriCor®/ Lipanthyl® (marketed by Abbott, Solvay), Megace® ES (marketed by Strativa Pharmaceuticals, a division of Par Pharmaceutical), Rapamune® (marketed by Wyeth) and Emend® (marketed by Merck).
 
The NanoCrystal Technology is part of a suite of capabilities available through Elan Drug Technologies (EDT). With over 30 products launched in 40 countries, EDT has a proven track record of collaborating with pharmaceutical companies. For more information about Elan Drug Technologies please visit www.elan.com/EDT.
 
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.
 
NanoCrystal® Technology is a registered trademark owned by Elan Pharma International Limited, Ireland.
 
TriCor® is a registered trademark owned by Abbott Laboratories Corporation.
 
Lipanthyl® is a registered trademark owned by Solvay SA.
 
Megace® is a registered trademark owned by Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
 
Rapamune® is a registered trademark owned by Wyeth Pharmaceuticals.
 
Emend® is a registered trademark owned by Merck & Co., Inc.
 

 
 

 

Final
30 October 2007

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties, including whether the License Agreement will be terminated, whether Elan will earn any further milestones under such Agreement, whether the product will be successfully commercialized, and, if so, whether Elan will receive any royalties on sales of the product, and whether Elan’s patents will provide any proprietary protection for the Elan technologies

A list and description of additional risks, uncertainties and other matters can be found in Elan’s Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and in its Reports of Foreign Issuer on Form 6-K filed with the Securities and Exchange Commission .   Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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