SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the period ended January 2, 2003
Elan Corporation, plc
(Translation of registrant's name into English)
Lincoln House, Lincoln Place, Dublin 2, Ireland
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover Form 20-F or Form 40-F.
Form 20-F /X/ Form 40-F / /
Indicate by check mark whether the registrant by furnishing the information
contained in this Form 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/
elan BIOGEN
MEDIA CONTACTS:
Elan -- Sunny Uberoi Biogen -- Tim Hunt Ketchum -- Amy Losak
212-994-8206 617-914-6524 646-935-3917
INVESTOR CONTACTS:
ELAN -- Jack Howarth (U.S.) Elan -- Emer Reynolds Biogen -- Elizabeth Woo
212-407-5740 (Europe) 617-679-2822
353-1-709-4000
ANTEGREN(R)(natalizumab) CLINICAL STUDY RESULTS PUBLISHED IN NEW ENGLAND
JOURNAL OF MEDICINE SHOW PROMISING DATA ON DISEASE REMISSION
AND QUALITY OF LIFE FOR PATIENTS WITH CROHN'S DISEASE
Antegren Phase II Results in Multiple Sclerosis
Published in Same Issue of Journal;
Novel Mechanism of Action Shows Promise in Two Diseases
Dublin, Ireland and Cambridge, MA, January 2, 2003 -- Elan Corporation, plc
(NYSE: ELN) ("Elan") and Biogen, Inc. (NASDAQ: BGEN) ("Biogen") announce the
publication of two clinical study reports on ANTEGREN(R) (natalizumab) in
today's issue of the New England Journal of Medicine. Natalizumab, a humanized
monoclonal antibody, showed promising results on disease remission and improved
quality of life for patients with Crohn's disease in an investigational study,
according to results published today. Crohn's disease, a chronic, progressive
and immune-related inflammatory disease of the gastrointestinal tract, can cause
a range of debilitating symptoms such as severe diarrhea, crampy abdominal pain
and malnutrition. Current treatment options for the disease are limited.
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Crohn's Disease Study Design and Results
----------------------------------------
The randomized, double-blind, placebo-controlled, parallel group, Phase II study
of 248 patients with Crohn's disease presented in the New England Journal of
Medicine was conducted in eight countries at 35 clinical trial sites. Patients
were randomized to one of four treatment groups: single 3 mg/kg natalizumab
infusion followed by placebo (n=68); two 3 mg/kg natalizumab infusions at
four-week intervals (n=66); two 6 mg/kg natalizumab infusions at four-week
intervals (n=51), or placebo (n=63) and all groups were observed for at least 12
weeks following the first infusion. Patients with moderate-to-severe active
Crohns' disease (Crohn's Disease Activity Index ("CDAI") scores of 220 to 450)
were included in the study. The primary measure of effectiveness was clinical
remission: a score of less than 150 on the CDAI. Clinical response was defined
as a decrease of at least 70 points in the CDAI from baseline. Additional
efficacy measures included quality of life assessments, as determined by the
Inflammatory Bowel Disease Questionnaire ("IBDQ").
Although the primary endpoint of remission at 6 weeks in the 6 mg/kg dose group
compared to placebo was not statistically significant, both groups that received
2 doses of natalizumab had higher rates of clinical remission (a score of less
than 150 points on the CDAI score) than the placebo group at multiple time
points. The highest rate of remission was in the 3 mg/kg dose group at 6 weeks,
with 44% of the natalizumab treated patients in clinical remission (n=29) versus
27% in the placebo group (n=17). A significant difference in clinical responses
(decrease of > 70 points in the CDAI score) was noted as early as week 2 and was
-
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maintained through week 12 with a maximal response of 71% in the dual 3 mg/kg
dose group (n=47) versus 38% in the placebo group (n=24).
Secondary outcomes included improvements in quality of life as determined by the
IBDQ. At week 6, improvements in IBDQ scores were seen across all three
natalizumab treated groups, with the highest difference occurring in the dual 6
mg/kg dose group (32 point improvement in IBDQ score from baseline (n=51) versus
15 point improvement in placebo (n=63)).
Natalizumab was generally well-tolerated in patients with active Crohn's disease
throughout the study. The most common adverse events reported were headache and
abdominal pain. There were no notable differences among treatment groups in the
number of patients reporting side effects.
"These results may hold promise of a future treatment option for the one million
people worldwide suffering from Crohn's disease," said Subrata Ghosh, MD, lead
author, consultant gastroenterologist, Imperial College London, Hammersmith
Hospital, UK. "Natalizumab targets the underlying problem in Crohn's disease in
a unique way and may provide a meaningful alternative to currently available
Crohn's disease therapies."
Natalizumab: First in New SAM Inhibitor Class
----------------------------------------------
Natalizumab is the first in a new class of drugs known as SAM (selective
adhesion molecule) inhibitors. In Crohn's disease, immune cells migrate into the
inflamed gastrointestinal tract and once there, they amplify the inflammatory
process; in multiple sclerosis ("MS"), this same
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process occurs but on the myelin sheaths (insulation) on the nerve cells in the
brain. Adhesion molecules on the surface of the immune cells play an important
role in this migration. Natalizumab binds to a specific adhesion molecule on the
immune cell surface known as alpha-4 integrin. By binding to alpah-4 integrin,
natalizumab is thought to inhibit immune cells from leaving the bloodstream and
prevent them from migrating into the inflamed gut tissue in Crohn's disease or
the brain tissue in MS.
Natalizumab, a drug in development by Elan and Biogen, is also being studied in
Phase III trials for the treatment of MS and may have potential in other
immune-related inflammatory diseases. The Phase II study results evaluating the
effects of natalizumab in reducing new inflammatory brain lesions and clinical
relapses in patients with relapsing forms of MS were also published in this
week's issue of The New England Journal of Medicine.
"The data published in these studies are very important in our understanding of
immune-mediated diseases like Crohn's and MS. By selectively blocking the
ability of immune cells to migrate to areas of chronic inflammation we may be
able to alter the course of underlying disease," said Stephen Hanauer, MD,
professor of medicine and clinical pharmacology, Director, section of
Gastroenterology and Nutrition, University of Chicago Hospitals and Health
System.
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Progression of Phase III Development Program: Largest-Ever Trial in Crohn's
---------------------------------------------------------------------------
Disease Fully Enrolled
----------------------
Four Phase III trials further evaluating the safety and efficacy of natalizumab
in both Crohn's disease and MS are underway. There are two trials in Crohn's
disease: ENACT-1 (Evaluation of Natalizumab in Active Crohn's Disease Trial-1),
the largest-ever study in Crohn's disease conducted to date, is now fully
enrolled with more than 850 patients and will evaluate clinical response and
ability to induce remission; ENACT-2 (Evaluation of Natalizumab As Continuous
Therapy-2) will evaluate duration of effect. Investigators expect ENACT-2 to be
fully enrolled shortly.
The two MS trials, both fully enrolled, will evaluate natalizumab in patients
with relapsing-remitting forms of the disease. AFFIRM (natalizumab safety and
efficacy in relapsing-remitting MS) will evaluate the ability of natalizumab to
slow the rate of disability in MS and reduce the rate of clinical relapses;
SENTINEL (safety and efficacy of natalizumab in combination with AVONEX(R)
(Interferon beta-la) in patients with relapsing-remitting MS) will determine if
the combination of natalizumab and AVONEX is more effective than treatment with
AVONEX alone in slowing rate of disability and reducing rate of clinical
relapses.
Elan is focused on the discovery, development, manufacturing, selling and
marketing of novel therapeutic products in neurology, pain management and
autoimmune diseases. Elan shares trade on the New York, London and Dublin Stock
Exchanges.
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Biogen is the world's oldest independent biotechnology company and a leader in
biologics research, development and manufacturing. A pioneer in leading edge
research in immunology, neurobiology and oncology, Biogen brings novel therapies
to improve patients' lives around the world through its global marketing
capabilities. For press releases and additional information about the company,
please visit http://www.biogen.com.
In addition to historical information, this press release contains
forward-looking statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995. Reference is made in
particular to statements regarding the potential for Antegren as a therapeutic
product and the progression of Phase III trials. These statements are based on
the companies' current beliefs and expectations as to such future outcomes. Drug
development involves a high degree of risk. Success in early stage clinical
trials does not ensure that later stage or larger scale clinical trials will be
successful. Factors which could cause actual results to differ materially from
the companies' current expectations include the risk that problems or delays may
arise during clinical trials or in the course of development, testing or
manufacturing of the product, that results in later stage or larger trials may
be different than those seen in earlier stage trials or that the product may not
show therapeutic effect or an acceptable safety profile in subsequent trials or
may not meet applicable regulatory standards. For more detailed information on
the risks and uncertainties associated with Elan and Biogen's drug development
and other activities see each company's periodic reports filed with the SEC.
Elan and Biogen assume no obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
###
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: January 3, 2003