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 September, 2005
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 / /
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 / / 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 / / 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
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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 / / 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 September 26, 2005 titled:
Biogen Idec and Elan submit supplemental Biologics License
Application to the FDA for TYSABRI(R) in 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: September 26, 2005
Exhibit 99.1
[Graphic Omitted]
For More Information Contact:
MEDIA CONTACTS:
Biogen Idec Elan
Amy Davia B. Temin
Brockelman Ph: 212 407 5740
Ph: 617 914 6524 Elizabeth Headon
353-1-498-0300
INVESTOR CONTACTS:
Biogen Idec Elan
Elizabeth Woo Emer Reynolds
Ph: 617 679 2812 Ph: 353 1 709 4000
Chris Burns
800 252 3526
BIOGEN IDEC AND ELAN SUBMIT SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION
TO THE FDA FOR TYSABRI(R) IN MULTIPLE SCLEROSIS
Cambridge, MA and Dublin, Ireland - September 26, 2005 - Biogen Idec (NASDAQ:
BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that they have
submitted a supplemental Biologics License Application (sBLA) for TYSABRI(R)
(natalizumab) to the U.S. Food and Drug Administration (FDA) for the treatment
of multiple sclerosis (MS).
The sBLA includes:
o final two-year data from the Phase III AFFIRM monotherapy trial and
SENTINEL add-on trial with AVONEX(R) (Interferon beta-1a) in MS;
o integrated safety assessment of patients treated with TYSABRI in clinical
trials; and
o revised label and risk management plan.
The companies have requested Priority Review status for the sBLA which, if
granted, would result in action by the FDA approximately six months from the
submission date, rather than 10 months for a standard review.
Biogen Idec and Elan will submit a similar data package to the European
Medicines Agency (EMEA). This information will be supplied as part of the
ongoing review process, which was initiated in the summer 2004 with the filing
for approval of TYSABRI as a treatment for MS.
"We are grateful to the MS community for their patience and support over the
last several months while we've conducted an extensive safety evaluation of
TYSABRI in collaboration with leading experts. We look forward to working with
regulatory authorities during the review process, and ultimately, we hope to
provide TYSABRI to people living with MS, a disease with significant unmet
need," said Burt Adelman, MD, executive vice president, Development, Biogen
Idec.
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Page 2 Biogen Idec and Elan Submit sBLA to the FDA for TYSABRI(R) in MS
"We are very encouraged by this filing. We strongly believe in the therapeutic
benefit of TYSABRI and the difference it could make in the lives of patients
with MS. We are committed to working closely with regulatory authorities to
define a path forward for TYSABRI as a treatment choice for patients who
struggle with the debilitating effects of the disease," said Lars Ekman, MD,
executive vice president and president, Research and Development, Elan.
On February 28, 2005, Biogen Idec and Elan announced that they voluntarily
suspended TYSABRI from the U.S. market and all ongoing clinical trials based on
reports of progressive multifocal leukoencephalopathy (PML), a rare and
potentially fatal, demyelinating disease of the central nervous system. Biogen
Idec and Elan subsequently launched a comprehensive safety evaluation in
collaboration with leading experts in PML and MS.
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 http://www.biogenidec.com.
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.
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 concerns may arise from additional
data or analysis, including the ongoing safety evaluation, or that the companies
may encounter other unexpected delays or hurdles. There is also no assurance
that the companies will be able to gain sufficient information to fully
understand the risks associated with TYSABRI or 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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