2 new treatments for cd soon

[Guest guest]

from the boston globe yesterday:

By Diedtra , Globe Staff | February 19,

2007

WASHINGTON -- For patients suffering from a severe

form of Crohn's disease, a remedy already on the shelf

to treat other maladies and a brand-new drug could

offer new hope.

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Alerts Within days, Illinois-based Abbott Laboratories

expects to win federal approval to sell its drug,

Humira , currently used to treat rheumatoid arthritis,

psoriatic arthritis, and a disease that causes

arthritis of the spine, to combat the intestinal

disorder.

The new use could produce up to about $500 million in

annual revenue for a drug that is produced at Abbott's

facility in Worcester.

Some 600,000 North Americans suffer from Crohn's, a

chronic, inflammatory disease of the gastrointestinal

tract.

The ailment is marked by debilitating flares that

trigger diarrhea, cramping, loss of appetite, and

weight loss.

It's a " wonder disease, " jokes Judi Walk, of Needham,

" because you're always wondering why you're sick. You

can be fabulous one morning and sick as a dog that

night, " said Walk, 63, who has struggled with Crohn's

symptoms since she was a teenager.

" When you have a flare-up, you're basically knocked

into bed, " Walk said. " A serious flare-up can stop

your life. "

Dr. Adam S. Cheifetz, who treats patients with

Crohn's, said only two-thirds respond to Centocor

Inc.'s Remicade , the first biologic treatment

approved by the Food and Drug Administration for

adults with moderate to severe Crohn's. Even those who

do respond can build resistance to Remicade over time.

" The biggest difference this is going to make is for

those people who had been doing well on Remicade, and

then lost their response. That was a problem group of

patients, " said Cheifetz, clinical director of the

Center for Inflammatory Bowel Disease at Beth Israel

Deaconess Medical Center. " For those patients we would

normally put on Remicade, now we have two drugs to

choose from. "

In clinical trials, 21 percent of patients who had

stopped responding to Remicade were coaxed into

remission by week four on Humira, compared with 7

percent who achieved remission on a placebo. Those

results were impressive enough for the FDA to speed

its handling of the drug -- trimming the review from

10 months to six months and indicating that an

approval decision could come by the end of February.

Because the FDA has already approved Humira for other

uses, doctors and patients would be able to purchase

it immediately after FDA approval, for roughly $600

per syringe wholesale, or $16,000 per year, according

to Abbott spokeswoman Shea.

People with Crohn's are often diagnosed between the

ages of 15 and 30, a " young and active patient

population, " said Shea, who added that Humira's other

selling point for people who plan their lives around

trips to the bathroom is the ease of being able to

self-administer the drug at home.

Cowen and Co. analysts factored that into their

projection that Humira would become a $4.3 billion

worldwide seller by 2010 and the dominant injectable

Crohn's drug in the United States, besting UCB

Pharma's once-monthly Cimzia , an experimental drug

that is also expected to receive FDA approval this

year.

For patients like Whelihan , a 25-year-old who

was home-schooled because she was too sick to attend

high school, the new drugs are a godsend. Whelihan

already has had two surgeries that removed much of her

large intestine. For now, Remicade works, and the

Westfield State College student is in her longest

remission ever.

But Whelihan is already planning for a future when

Remicade might not work. " It never hurts to have more

options with a disease like this, " she said.

A third possible option for Crohn's patients is Biogen

Idec's multiple sclerosis therapy Tysabri.

Tysabri was greeted with excitement because of its

ability to keep Crohn's patients in remission in

clinical trials, and because it works by a different

mechanism than the other drugs.

The multiple sclerosis remedy was pulled from the

market after being linked to a rare brain infection.

But regulators have allowed renewed sales and, on Dec.

15, Biogen Idec said it was seeking FDA approval to

sell the drug as a treatment for moderately to

severely active Crohn's disease.

M. Chao , a senior biotechnology analyst at

Deutsche Bank , however, maintains a forecast of no

revenue from its future use as a Crohn's therapy.

" Tysabri is much more of a long shot, at this point, "

Cheifetz agreed.

Diedtra can be reached at

dhendersonglobe (DOT) com.

[Guest guest]

Hi Jeff,

Thanks for that article. It's great news. Always good to have a

contingency drug (or 2)in case you need it.

Also thanks for the article on plant based omegas. Steve eats walnuts

daily and I eat ground flax seeds on my oatmeal for breakfast. We both

take calcium supplements. Steve has osteopenia and will soon take a

retest to see if the supplements [without Fosamax] are improving his

scores.

Love,

idio. EN '68