ANTEGREN, 8 November 2004

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ANTEGREN, 8 November 2004

8 November 2004

ANTEGREN One-Year Data from Phase III AFFIRM Study Showed Compelling

Results in Meeting Primary Endpoint in Multiple Sclerosis

One-Year Data Show 66% Reduction in Relapse Rate

http://www.elan.com/News/full.asp?ID=641172

CAMBRIDGE, Mass. and SAN DIEGO, Calif. and DUBLIN, Ireland--(BUSINESS

WIRE)--Nov. 8, 2004-- Biogen Idec (NASDAQ: BIIB) and Elan Corporation,

plc (NYSE: ELN) announced today that one-year data from the Phase III

ANTEGREN® (natalizumab) AFFIRM trial met the primary endpoint of

clinical relapse rate reduction. In this international study of 942

patients with relapsing-remitting multiple sclerosis (RRMS),

natalizumab reduced the rate of relapses by 66 percent compared to

placebo, a statistically significant result. All secondary endpoints

were also met. These data were presented to investigators involved in

the Phase III MS program for natalizumab at a meeting over the

weekend. Natalizumab is currently under regulatory review for approval

as a treatment for MS.

The AFFIRM study is a two-year trial evaluating the effect of

natalizumab on the progression of disability and the rate of relapses

in MS. The primary endpoint of the one-year analysis was relapse rate.

The companies anticipate that the two-year results will be available

in the first half of 2005.

Adverse events occurring in at least 5 percent of natalizumab-treated

patients that were 2 percent more common than in placebo-treated

patients included headache, fatigue and arthralgia. The overall

incidence of infection was similar between the groups. Serious

infections occurred in 1 percent of placebo-treated patients and 2

percent of natalizumab-treated patients. Serious hypersensitivity-like

reactions occurred in approximately 1 percent of natalizumab-treated

patients.

" These data demonstrate that natalizumab dramatically reduced the rate

of relapses at one year, " said Burt Adelman, MD, executive vice

president, Development, Biogen Idec. " We believe natalizumab, with its

novel mechanism of action, has the potential to be a significant step

forward in the treatment of MS. "

" Natalizumab has the potential to make a real difference in the lives

of MS patients, " said Lars Ekman, executive vice president and

president, Research and Development, Elan. " We are working closely

with regulatory authorities to make natalizumab available to patients

in need as soon as we can. "

The AFFIRM trial is a two-year, randomized, multi-center,

placebo-controlled, double-blind study of 942 patients evaluating the

effect of natalizumab monotherapy on the progression of disability in

MS and the rate of clinical relapses. Secondary endpoints at one year

included the number of new or newly enlarging T2-hyperintense lesions,

the number of gadolinium-enhancing lesions and the proportion of

patients who were relapse free. To enroll, patients had to be

diagnosed with a relapsing form of MS and had to have experienced at

least one relapse in the previous year. Patients were randomized to

receive a 300 mg IV infusion of natalizumab (n=627) or placebo (n=315)

once a month.

" This was a rigorous, well-conducted clinical trial across 99 sites

worldwide that yielded compelling one-year results, " 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. " These data suggest that natalizumab may become a

promising new treatment option for patients with MS and could help

address a significant unmet need. "

Biogen Idec and Elan have submitted regulatory applications for the

approval of natalizumab as a treatment for MS in the U.S., EU, Canada,

and Australia based on one-year data from two ongoing Phase III

trials. On May 25, the companies announced that they had submitted a

Biologics License Application (BLA) to the U.S. Food and Drug

Administration (FDA). The FDA designated natalizumab for Priority

Review and Accelerated Approval. Based on the FDA's designation of

Priority Review, the companies anticipate action by the FDA

approximately six months from the submission date, rather than 10

months for a standard review. Regulatory authorities in Canada and

Australia have also designated natalizumab for Priority Review, and

the European Medicines Agency (EMEA) is actively reviewing the

application.

A second Phase III trial, SENTINEL, is a two-year randomized,

multi-center, placebo-controlled, double-blind study of approximately

1,200 patients with relapsing-remitting MS, evaluating the effect of

the combination of natalizumab and AVONEX® (Interferon beta-1a)

compared with AVONEX alone on the progression of disability and the

rate of clinical relapses.

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 ANTEGREN (natalizumab)

Natalizumab, a humanized monoclonal antibody, is the first alpha-4

integrin antagonist in the new selective adhesion molecule (SAM)

inhibitor class.

It is designed to inhibit the migration of immune cells into tissues

where they may cause or maintain inflammation. To date, over 2,800

patients have received natalizumab in clinical trials.

Biogen Idec and Elan are collaborating equally on the development of

natalizumab in MS, Crohn's disease (CD), and rheumatoid arthritis

(RA). In September 2004, a Marketing Authorisation Application (MAA)

for CD was filed with the EMEA based on Phase III studies, and another

Phase III induction trial for CD is ongoing. A Phase II trial is also

underway to evaluate natalizumab in RA.

Webcast

The companies will host a webcast for the investment community today

at 8:30 a.m. EST, 1:30 p.m. GMT, which can be accessed through the

companies' websites.

About Biogen Idec

Biogen Idec 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 AVONEX

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.

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 of ANTEGREN (natalizumab) as a treatment for multiple

sclerosis, Crohn's disease and rheumatoid arthritis. These statements

are based on the companies' current beliefs and expectations. Drug

development involves a high degree of risk. Factors which could cause

actual results to differ materially from the companies' current

expectations include the risk that unexpected concerns may arise from

additional data or analysis, that regulatory authorities may require

additional information, further studies, or may fail to approve the

drug for marketing, or that the companies may encounter other

unexpected hurdles. For more detailed information on the risks and

uncertainties associated with the companies' drug development and

other activities, see the periodic 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.

CONTACT: Media Contacts:

Biogen Idec

Amy Brockelman, 617-914-6524

or

Elan

Anita Kawatra, 212-407-5740

Phone: 800-252-3526

or

Investor Contacts:

Biogen Idec

Woo, 617-679-2812

or

Elan

Emer Reynolds, 353 1 709 4000

Phone: 800-252-3526

SOURCE: Biogen Idec and Elan Corporation, plc

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