BACKGROUND (article follows), According to Wikipedia (wfiw):

"...Natalizumab [aka Tysabri] is the first alpha-4 antagonist in a new
class of agents called selective adhesion-molecule (SAM) inhibitors.
Alpha-4 integrin is required for leukocytes to migrate into the body's
organs such as the brain and gut; natalizumab prevents leukocytes from
doing that."

"...In these trials[1][2], natalizumab was shown to reduce relapses in MS
patients by 68% vs. a placebo, a margin far greater than had been seen for
other approved MS therapies."

"...Also in these trials natalizumab slowed the progression of disability
(as measured by EDSS) by approximately 50% [3] (the US and EU medical
authorities use slightly different measures of disability progression, and
use values of between 42% and 54%)."

"...In Crohn's, a randomized controlled trial found that natalizumab
increased the rate of remission."

"...Two further randomized controlled trials have confirmed natalizumab's
effectiveness in increasing the rate of remission and in maintaning
remission in Crohn's."

"...the annual costs for Tysabri is approximately US$28,400 (not including
costs associated with infusion services)..."

Tysabri had been withdrawn from the market after the occurance of a rare
brain disease in two patients taking the drug.

<http://en.wikipedia.org/wiki/Natalizumab>

-- Dale
<http://DaleRoose.com>
If a small improvement in the DNA of cattle could give them the power of
speech, would that genetic modification be allowed?
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<http://www.boston.com/business/globe/articles/2008/01/15/biogen_idecs_ms_drug_o\
kd_for_crohns_disease/>

Biogen Idec's MS drug OK'd for Crohn's disease

But approval includes warnings on safety

By Todd Wallack
Globe Staff / January 15, 2008

Federal regulators yesterday gave Biogen Idec Inc. good news about one of
the Cambridge biotech company's key drugs.

Tysabri, a treatment for multiple sclerosis, won approval from the Food
and Drug Administration to be used against another debilitating illness,
Crohn's disease.

The move comes six months after an FDA advisory panel voted 12 to 3 to
recommend the drug's approval to treat some forms of Crohn's, a chronic
inflammatory disease of the intestinal tract. FDA officials said the final
decision was delayed because Biogen Idec and Elan Corp., the Irish company
that comarkets the drug, made changes to their application for a Crohn's
approval.

European regulators recently rejected a similar request to use the drug as
a Crohn's treatment, arguing the risk of infection outweighed the
relatively modest benefit of Tysabri.

Biogen Idec temporarily shelved the drug three years ago after it was
linked to a rare brain disease. The company says there have not been any
additional cases of the disease since sales resumed in 2006, with new
guidance on how it should be used. But some doctors remain wary of the
treatment, even though it has been shown to be highly effective in some
patients.

Despite the safety concerns, Biogen Idec has predicted Tysabri will
eventually become a major source of revenue. This month, the company
reaffirmed predictions it will be used by 100,000 patients by the end of
2010, up from more than 21,000 at the end of 2007.

Biogen Idec shares rose late in the day after the FDA news was released.
The shares finished up 96 cents to $59.98, a gain of 1.6 percent.

Doctors already had permission to use the drug to treat Crohn's disease on
their own, but Biogen Idec needed formal approval to start marketing the
drug for that purpose.

The FDA decision does carry some caveats. Specifically, the agency
approved the drug to treat patients with moderate to serious cases of the
disease who can't be treated effectively with other drugs, such as
steroids. The label will also carry safety warnings to reduce the risk
that patients will contract the brain disease or other infections.

About 500,000 people in the United States suffer from Crohn's, but it is
unclear how many of them will qualify to use Tysabri. The disease
frequently causes diarrhea and abdominal cramps; symptoms can also include
fever, bleeding, and weight loss. There is no cure.

Biogen Idec and Elan said they expect the drug to be available for Crohn's
patients by the end of February.