Fwd: NEW MS DRUG Rx

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In a message dated 06/30/2004 3:24:54 PM Eastern Daylight Time, bakkenjr@... writes:

THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

Biogen Idec to get fast-track review

FDA to speed request to market MS drug

By Ross Kerber, Globe Staff  |  June 29, 2004

Biogen Idec Inc. yesterday said the US Food and Drug Administration

agreed to fast-track its application to market a multiple sclerosis drug

the Cambridge biotechnology company is developing jointly with Elan

Corp. of Ireland.

Biogen Idec said the FDA's decision was based on promising interim

results from two ongoing clinical trials for the treatment known as

Antegren. The regulator will now likely decide within six months whether

to approve the drug, rather than the usual 10 months, meaning Antegren

could be on the market as soon as the end of this year.

The companies won't discuss the specific results of the clinical trials

so far. The trials are expected to be completed next year. The companies

said on May 25 that they had filed an application to market Antegren.

Biogen Idec executives declined to provide the date of the filing,

however, so outsiders don't know exactly when the agency might make a

decision on the submission.

Still, the FDA's decision to grant priority review suggests the agency

sees some cause for confidence in the data so far.

''It means they think the clinical significance of the data, both for

safety and efficacy, are remarkable enough to warrant accelerated

review, " said Burt A. Adelman, Biogen Idec executive vice president for

development, in a telephone interview yesterday.

Earning fast-track status means the FDA designated the drug for

''priority review and accelerated approval, " which relatively few

applicants get. For instance, in the fiscal year ended in 2002, eight

drugs were approved on a priority schedule, according to the FDA,

compared with 47 drugs approved on the standard schedule.

In exchange for the accelerated review, Adelman said, Biogen Idec will

likely have to be conservative in the claims it makes to promote

Antegren, assuming it is approved before all of the trial data is in.

While it's not unusual for drugs to be approved before their clinical

trials end, drug companies can seek to make broader claims about their

products once all of the trial data is complete.

About 1 million people suffer from MS, an autoimmune disease affecting

the central nervous system in which the body's own cells attack the

myelin, a fatty tissue that surrounds and protects nerve fibers. It

affects more women than men, typically striking people between ages 20

and 40, the companies said. Symptoms are hard to predict but may include

fatigue, visual problems, loss of balance and muscle coordination,

tremors, and stiffness.

Biogen Idec estimates the total MS drug market to be worth about $3.6

billion, growing to about $6 billion over the next few years -- driven

by newer, more expensive drugs. In addition to Biogen Idec's

longstanding MS treatment Avonex, drugs to treat the disease include

Serono SA's new Rebif and Schering AG's Betaseron.

Biogen Idec has spent heavily to develop Antegren as a successor to

Avonex. It hopes Antegren will be the first of a new group of treatments

to inhibit immune cells from leaving the bloodstream to attack inflamed

tissue.

Elan is sharing development costs. Biogen Idec is focusing on the

research needed to approve Antegren for MS, while Elan aims to show

Antegren is also effective for treating Crohn's disease, a digestive

disorder, and rheumatoid arthritis.

One of the two trials underway involves giving Antegren to some of 900

patients to evaluate whether the drug slows the rate of disability

caused by MS and reduces the rate of clinical relapses.

The second trial evaluates Antegren combined with Avonex in some of

1,200 patients to see whether the cocktail of both drugs is more

effective than Avonex alone at slowing the progression of disability and

reducing the rate of relapses.

Biogen Idec had said Feb. 18 it would seek the early approval, sending

its shares up more than 20 percent that day to close at $53.23.

For the most part they have remained slightly higher ever since, and

yesterday they rose 33 cents to close at $62.70 in Nasdaq trading.

Shares in Elan rose 43 cents to $24.40.

The companies have already submitted an application for Antegren to

European regulators as well, and said they will seek an accelerated

acceptance there.

Ross Kerber can be reached at kerber@.... 

© Copyright 2004 The New York Times Company