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 April, 2005
Commission File Number 001-13896
Elan Corporation, plc
(Translation of registrant's name into English)
Treasury Building, Lower Grand 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/
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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 / / 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 and 333-100252).
EXHIBIT LIST
Exhibit Description
99.1 Press release dated April 12, 2005 titled:
TYSABRI(R) two-year monotherapy data support positive one-year
efficacy findings and show significant reduction in risk of
disability progression. Data presented at American Academy of
Neurology meeting.
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
Company Secretary
Date: April 12, 2005
Exhibit 99.1
For More Information Contact:
MEDIA CONTACTS:
Biogen Idec Elan
Amy Brockelman Anita Kawatra or
Ph: 617 914 6524 Brian McGlynn
Ph: 212 407 5740
800 252 3526
INVESTOR CONTACTS:
Biogen Idec Elan
Elizabeth Woo Emer Reynolds
Ph: 617 679 2812 Ph: 353 1 709 4000
800 252 3526
TYSABRI(R) TWO-YEAR MONOTHERAPY DATA SUPPORT POSITIVE ONE-YEAR EFFICACY
FINDINGS AND SHOW SIGNIFICANT REDUCTION IN RISK OF DISABILITY
PROGRESSION
Data Presented at American Academy of Neurology Meeting
Cambridge, MA and Dublin, Ireland - April 12, 2005 -Two-year data from the
AFFIRM Phase III monotherapy trial presented today for the first time, showed
that treatment with TYSBARI(R) (natalizumab) led to a significant reduction in
disability progression, the rate of clinical relapses and brain lesions in
patients with relapsing forms of multiple sclerosis (MS). These data were
presented at the 57th annual American Academy of Neurology (AAN) meeting in
Miami Beach, FL.
AFFIRM met all primary and secondary endpoints, including disability progression
and relapse rate. TYSABRI treatment was also associated with a low level of
immunogenicity.
TYSABRI treatment led to a 42 percent (p=0.0002) reduction in the risk of
disability progression compared to placebo. TYSABRI also reduced the rate of
clinical relapses by 67 percent (p<0.0001) compared to placebo, which was
sustained and consistent with the previously reported one-year results.
On February 28, 2005, Biogen Idec and Elan Corporation, plc announced that they
voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical
trials. This decision was based on reports of progressive multifocal
leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of
the central nervous system. Biogen Idec and Elan's comprehensive safety
evaluation concerning TYSABRI and any possible link to PML is ongoing. The
results of this safety evaluation will be discussed with regulatory agencies to
determine possible re-initiation of dosing in clinical trials and future
commercial availability.
"While an evaluation is underway to better understand recent developments with
TYSABRI, these data confirm the efficacy of TYSABRI on clinical relapse and
define its impact on disability progression," said Chris Polman, MD, PhD, lead
investigator of the AFFIRM study, professor of Neurology at Free University
Medical Centre, and clinical and scientific director of the Multiple Sclerosis
Centre at the VU Medical Centre, Amsterdam. "Disability progression is an
important consideration in managing MS. The efficacy of TYSABRI underscores its
importance for MS patients."
Results From Two-Year AFFIRM
AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blind
study of 942 patients conducted in 99 sites worldwide, evaluating the effect of
TYSABRI on the progression of disability as measured by at least a one-point
increase on the Expanded Disability Status Scale (EDSS) sustained for three
months, and the rate of clinical relapses. Progression of disability is a
sustained change that has a long-term impact on a patient's functional and
ambulatory performance. Patients in AFFIRM were randomized to receive either a
300 mg IV infusion dose of TYSABRI (n=627) or placebo (n=315) every four weeks.
Disability
TYSABRI-treated patients were less likely to experience progression of
disability. The risk of disability progression sustained for three months was
reduced by 42 percent relative to placebo (p=0.0002), the two-year primary
endpoint. Additionally, after two years, 29 percent of placebo-treated patients
had progressed, while only 17 percent of TYSABRI-treated patients progressed,
representing a 41 percent reduction in the proportion of patients progressing
(p<0.0001).
TYSABRI also slowed the progression of disability as demonstrated by the mean
Multiple Sclerosis Functional Composite (MSFC) score. The MSFC consists of three
tests that evaluate ambulation, upper extremity dexterity and cognitive
function.
A pre-defined sensitivity analysis of the primary endpoint defined progression
as at least a one-point increase on the EDSS sustained for six months. Using
this definition, the risk of disability progression was reduced by 54 percent
with TYSABRI treatment.
Relapse Rate
Data also demonstrated a 67 percent reduction in the rate of clinical relapses
relative to placebo (p<0.0001) over two years, which was sustained and
consistent with the previously reported one-year results. The annualized relapse
rate was 0.22 for TYSABRI-treated patients compared to 0.67 for placebo-treated
patients. The proportion of patients who remained relapse free was 67 percent in
the TYSABRI-treated group compared to 41 percent in the placebo-treated group
(p<0.0001).
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MRI measures
MRI analysis examining different types of brain lesions is used in the initial
diagnosis of MS and is a marker of ongoing and previous disease activity and
damage. TYSABRI treatment resulted in sustained and statistically significant
reductions in the number and volume of gadolinium enhancing, T2-hyperintense and
T1-hypointense lesions compared to placebo. The pre-specified secondary endpoint
MRI measures were the volume of T2-hyperintense lesions and the number of new
T1-hypointense lesions.
Over two years, there was a significant difference in the burden of disease as
measured by change in T2-hyperintense lesion volume. Placebo-treated patients
experienced an increase in burden of disease while TYSABRI-treated patients had
a decrease. In addition, TYSABRI demonstrated a 76 percent reduction in the mean
number of new T1-hypointense lesions compared to placebo.
AFFIRM Safety Summary
The two-year adverse event profile in AFFIRM was consistent with previously
reported one-year results. Common events included headache, fatigue, urinary
tract infection, depression, lower respiratory tract infection, limb and joint
pain, and pharyngitis. The rate and incidence of infections in TYSABRI-treated
and placebo-treated patients were similar. Serious infections occurred in 3.2
percent and 2.6 percent of TYSABRI-treated and placebo-treated patients,
respectively. TYSABRI has also been associated with hypersensitivity reactions,
including serious systemic reactions that occurred at an incidence of less than
1 percent of patients.
Immunogenicity
All biologics have the potential to induce antibody formation. Analysis of the
two-year data from the AFFIRM study indicated a low level of immunogenicity
associated with TYSABRI. Patients were tested for antibodies every 12 weeks.
Antibodies were detected in approximately 9 percent of patients at least once
during treatment, with 6 percent of patients remaining persistently positive.
Persistently positive antibodies were associated with a substantial decrease in
efficacy and an increase in certain infusion-related adverse events. Almost all
patients who tested positive for antibodies did so within the first 12 weeks of
treatment.
"We believe in the significant therapeutic benefit of TYSABRI in MS, a disease
with high unmet need," said Burt Adelman, MD, executive vice president,
Development, Biogen Idec. "Biogen Idec and Elan are working diligently to
evaluate extensive data from our clinical trials, consulting with leading
experts and with regulatory agencies throughout this process. We hope to define
a path forward for this product, and our future steps, as always, will be guided
by our commitment to people living with MS."
"We are very encouraged by the two-year results which support the efficacy of
TYSABRI in MS," said Lars Ekman, MD, PhD, executive vice president and
president, Research and Development, Elan. "Patient safety is our top priority,
and we are working closely with the regulatory agencies to define the
appropriate benefit-risk profile for TYSABRI as a new option to treat MS."
About TYSABRI
Biogen Idec and Elan are collaborating equally on the development of TYSABRI in
MS, Crohn's disease, and rheumatoid arthritis. On February 28, 2005, Biogen Idec
and Elan
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announced that they voluntarily suspended TYSABRI from the U.S. market and all
ongoing clinical trials. Worldwide regulatory agencies are being kept informed
of developments related to TYSABRI.
Information about TYSABRI, including the voluntary suspension of marketing, U.S.
prescribing information and support services, is available through a single
toll-free number (1-800-456-2255), and via www.TYSABRI.com.
About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately
400,000 people in North America and more than one million people worldwide. It
is a disease that affects more women than men, with onset typically occurring
between 20 and 40 years of age. Symptoms of MS may include vision problems, loss
of balance, numbness, difficulty walking and paralysis.
About Biogen Idec
Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology 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 (NYSE: ELN), plc is a neuroscience-based biotechnology company.
We are committed to making a difference in the lives of patients and their
families by dedicating ourselves 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
for TYSABRI. These statements are based on the companies' current beliefs and
expectations, and are subject to risks and uncertainties that could cause actual
results to differ materially. There is no assurance, for example, that the
serious adverse events discussed above were not caused by TYSABRI, that there
are not or will not be more such serious adverse events or that we will be able
to gain sufficient information to fully understand the risks associated with the
product. There is also no assurance that the companies will be able to resume
marketing and sales of TYSABRI. For more detailed information on the risks and
uncertainties associated with TYSABRI and the companies' drug development and
other activities, see the periodic and other reports of Biogen Idec Inc. and
Elan Corporation, plc 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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