-----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, BT6N6kqCv+GFaDSAyXiPaPKeAStp2DATbxWz1VqrT7MZwCtBKHwq+XC1gjtZcRG2 tewGMCECE09fGkp5cXuBtA== 0000950162-10-000013.txt : 20100125 0000950162-10-000013.hdr.sgml : 20100125 20100125111003 ACCESSION NUMBER: 0000950162-10-000013 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100125 FILED AS OF DATE: 20100125 DATE AS OF CHANGE: 20100125 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: 10543685 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_012510.htm ELAN CORP. PLC - 6K - 01/25/10 elan6k_012510.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 January, 2010.
 
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 January 25, 2010 titled:
Elan Drug Technologies welcomes the NDA approval of MS drug AMPYRA™ (dalfampridine) extended release tablets.





 
 

 

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: January 25, 2010



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

MEDIA CONTACT:
INVESTOR CONTACTS:
Mary Stutts
Ph: 650 794 4403
 
Niamh Lyons
Ph: 353-1-663-3602
Chris Burns
Ph: 800 252 3526
 
David Marshall
Ph: 353 1 709 4444
 


Elan Drug Technologies welcomes the NDA approval of MS Drug
AMPYRA (dalfampridine) Extended Release Tablets

Ampyra approved  using  Elan’s  proprietary MXDAS (MatriX  Drug Absorption System) drug delivery technology

DUBLIN, IRELAND, January 25, 2010, Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS).  This was demonstrated by an increase in walking speed. AMPYRA will be marketed in the U.S. by Acorda Therapeutics (NASDAQ:ACOR).

Using Elan Drug Technologies MXDAS technology, AMPYRA was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced.  AMPYRA is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS technology.

“We wish to congratulate Acorda Therapeutics on the approval of AMPYRA, which will bring a very important and much needed therapy to the market for MS sufferers,” announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “This is the second product on which we have worked with Acorda and represents another significant milestone in our successful collaboration with them. It also marks the second product approved by the FDA in the last six months

 
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incorporating our technologies and reinforces our position of leadership in drug delivery.”

This is the first medicine approved by the FDA indicated to improve walking speed in people with MS. The approval and subsequent launch of AMPYRA therefore may represent an important new addition to MS therapy. Approximately 400,000-500,000 people in the United States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability. Some 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease.

“We are very proud to announce the approval of AMPYRA and we thank Elan for their collaboration throughout the development program for this drug. Elan’s expertise in formulation development, which resulted in this extended-release tablet, was a critical component of the AMPYRA clinical program,” stated Ron Cohen, MD., President and CEO of Acorda.  “Elan has shared our commitment to bringing important new therapies to the market to improve the lives of people with MS throughout the decade we have worked together and we look forward to continuing to find opportunities to work together in the future.”

AMPYRA will be manufactured by Elan at its Athlone, Ireland facility, based on an existing supply agreement with Acorda.

About AMPYRA

AMPYRA is a potassium channel blocker approved for the improvement of walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA, was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine or 4-AP), which was previously called fampridine. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA was developed using Elan Drug Technologies Oral Controlled Release MXDAS(MatriX Drug Absorption System) technology and will be marketed in the United States by Acorda Therapeutics and by Biogen Idec in markets outside the U.S. AMPYRA is manufactured globally by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc at its Athlone, Ireland facility.

 
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About Elan Drug Technologies
 
Elan Drug Technologies (EDT) a leading drug delivery company is a business unit of Elan Corporation, plc. EDT developed the sustained release formulation of dalfampridine, using one of its Oral Controlled Release Technologies, the MXDAS (MatriX Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. EDT aims to deliver clinically meaningful benefits to patients by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. Products enabled by EDT technologies are used by millions of patients each day.  More information is available at www.elandrugtechnologies.com
 
About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's products include AMPYRA (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with multiple sclerosis (MS), this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
 
AMPYRA and Zanaflex Capsules® are trademarks of Acorda Therapeutics Inc
 
MXDAS and NanoCrystal® are  trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.
 
Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on

 
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Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc
###

 
 
 
 
 
 
 
 
 
 
4
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