Antegren trial news - OT

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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

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 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.