article

[Guest guest]

thanks for shareing pat, very informative/interesting.

Regards,

Article

14 Years Later, Insulin Saga Continues

If it were a novel, the story of a new form of insulin for treating diabetes

could be called " Waiting to Inhale. "

It started in 1990, when Inhale Therapeutic Systems was launched with the

idea of delivering prescription drugs, not by injection or pills, but

through

an inhaler. And its first goal was to produce inhalable insulin.

It makes perfect sense. Millions of type 1 diabetics require insulin shots

at least two or three times a day to stay alive. Injecting it even more

often

can mean better control of blood sugar and helps avoid long-term

complications. And for many of those with type 2 diabetes, the kind that

develops later

in life, insulin shots are needed when oral medications can't do the job.

Ouch!

As casual as many diabetics become about injections, surely they'd pay a

premium if they could avoid them.

But the obstacles were formidable, recalled S. Patton, co-founder of

the company, which was renamed Nektar Therapeutics last year. He and his

co-founder,

chemical engineer M. Platz, needed to find a way to deliver a

controlled amount of the drug to the lungs reliably. That required finding a

way to

produce an insulin powder so fine that it would form a little cloud inside

the inhaler and could easily reach the depths of the lungs for absorption

into

the blood.

" The lungs are like an upside-down oak tree, " said Patton, now Nektar's

chief scientific officer. " You have to get it all out to the leaves. "

That's different from the usual asthma inhaler that shoots a jet of

medication at 90 miles an hour toward the back of the throat. The powder

required was

so fine that the young company had to devise a new way of loading it into

the inhaler, by sealing it into little plastic bubbles so it could be

delivered

with a minimum of handling.

Preliminary testing showed that it worked. Insulin delivered in this way to

the lungs could safely control diabetes. And Pfizer and Aventis signed on to

complete the large-scale studies needed to win Food and Drug Administration

approval for marketing the inhalable insulin, called Exubera.

But satisfying the FDA isn't easy.

And there were worrisome issues with Exubera: Patients developed antibodies

to the inhalable insulin, for example. But a recently released study shows

that

the antibodies don't appear to compromise the effectiveness of treatment.

Some patients have been using Exubera successfully for four years now. And

it

seems to work well in those type 2 diabetics who can't control their blood

sugar with the current crop of oral medications.

Patton says that initially patients would use their inhaler in place of

needles before meals, but they'll still need an injection of longer-acting

insulin

every night.

Nektar isn't alone in pursuing inhalable insulin: A Massachusetts company,

Alkermes, is working with Eli Lilly to produce their own inhalable product.

And there's another potential problem in reaching patients. Several

companies have been working on ways to modify insulin so that it can be

taken as a pill.

If pills were available, would anyone bother with an inhaler?

Patton isn't worried. " People have talked about oral insulin forever, " he

said. " Many entered the field and it's full of gravestones. "

Nektar's partners, Pfizer and Aventis, have now applied for European

approval of Exubera. But the European experts reviewing the drug have raised

safety

concerns, according to an account published earlier this month that sent

Nektar shares tumbling. The companies have still not requested approval from

the

FDA in the United States.

Meanwhile, Nektar has a lot more irons in the fire, as a result of acquiring

other companies. It now owns a technology, called PEGylation, for chemically

transforming drugs so that they stay in the body longer. A number of

companies, including Amgen and Roche, have licensed the technology, which

brings a

small but steady stream of revenue into Nektar, while it works toward

developing new products of its own.

But after 14 years, doctors still can't prescribe inhalable insulin for

their patients.

[Guest guest]

thanks for shareing pat, very informative/interesting.

Regards,

Article

14 Years Later, Insulin Saga Continues

If it were a novel, the story of a new form of insulin for treating diabetes

could be called " Waiting to Inhale. "

It started in 1990, when Inhale Therapeutic Systems was launched with the

idea of delivering prescription drugs, not by injection or pills, but

through

an inhaler. And its first goal was to produce inhalable insulin.

It makes perfect sense. Millions of type 1 diabetics require insulin shots

at least two or three times a day to stay alive. Injecting it even more

often

can mean better control of blood sugar and helps avoid long-term

complications. And for many of those with type 2 diabetes, the kind that

develops later

in life, insulin shots are needed when oral medications can't do the job.

Ouch!

As casual as many diabetics become about injections, surely they'd pay a

premium if they could avoid them.

But the obstacles were formidable, recalled S. Patton, co-founder of

the company, which was renamed Nektar Therapeutics last year. He and his

co-founder,

chemical engineer M. Platz, needed to find a way to deliver a

controlled amount of the drug to the lungs reliably. That required finding a

way to

produce an insulin powder so fine that it would form a little cloud inside

the inhaler and could easily reach the depths of the lungs for absorption

into

the blood.

" The lungs are like an upside-down oak tree, " said Patton, now Nektar's

chief scientific officer. " You have to get it all out to the leaves. "

That's different from the usual asthma inhaler that shoots a jet of

medication at 90 miles an hour toward the back of the throat. The powder

required was

so fine that the young company had to devise a new way of loading it into

the inhaler, by sealing it into little plastic bubbles so it could be

delivered

with a minimum of handling.

Preliminary testing showed that it worked. Insulin delivered in this way to

the lungs could safely control diabetes. And Pfizer and Aventis signed on to

complete the large-scale studies needed to win Food and Drug Administration

approval for marketing the inhalable insulin, called Exubera.

But satisfying the FDA isn't easy.

And there were worrisome issues with Exubera: Patients developed antibodies

to the inhalable insulin, for example. But a recently released study shows

that

the antibodies don't appear to compromise the effectiveness of treatment.

Some patients have been using Exubera successfully for four years now. And

it

seems to work well in those type 2 diabetics who can't control their blood

sugar with the current crop of oral medications.

Patton says that initially patients would use their inhaler in place of

needles before meals, but they'll still need an injection of longer-acting

insulin

every night.

Nektar isn't alone in pursuing inhalable insulin: A Massachusetts company,

Alkermes, is working with Eli Lilly to produce their own inhalable product.

And there's another potential problem in reaching patients. Several

companies have been working on ways to modify insulin so that it can be

taken as a pill.

If pills were available, would anyone bother with an inhaler?

Patton isn't worried. " People have talked about oral insulin forever, " he

said. " Many entered the field and it's full of gravestones. "

Nektar's partners, Pfizer and Aventis, have now applied for European

approval of Exubera. But the European experts reviewing the drug have raised

safety

concerns, according to an account published earlier this month that sent

Nektar shares tumbling. The companies have still not requested approval from

the

FDA in the United States.

Meanwhile, Nektar has a lot more irons in the fire, as a result of acquiring

other companies. It now owns a technology, called PEGylation, for chemically

transforming drugs so that they stay in the body longer. A number of

companies, including Amgen and Roche, have licensed the technology, which

brings a

small but steady stream of revenue into Nektar, while it works toward

developing new products of its own.

But after 14 years, doctors still can't prescribe inhalable insulin for

their patients.

[Guest guest]

I had taken it upon my self to cut the 300 recommended dosage in half because my

triglycerids were good. I thought it would give my liver a little more of a

break. I will be seeing my regular physician, who put me on it originally, in a

month, and I'll ask her about upping it. Actually, it wouldn't be harmful to go

ahead and start taking the recommended 300 mg now I suppose.

Dave

article

To learn more, click here:

http://americandiabetesassn.org/GoNow/a16366a110846a173159749a3

=========================================

4. Statins Cut Risk of Heart Attacks in people with Diabetes, Study Finds

=========================================

People suffering from the most common form of diabetes could sharply cut

their

risk for heart attacks and strokes by taking a cholesterol-lowering drug

even if

they have normal cholesterol levels, according to a major new study.

The study of more than 2,800 patients with Type 2 diabetes found that

those

who

took the cholesterol drug Lipitor were more than one-third less likely to

have a

heart attack, nearly half as likely to have a stroke and about one-third

less

likely to die from any form of cardiovascular disease.

To learn more, click here:

http://americandiabetesassn.org/GoNow/a16366a110846a173159749a0

[Guest guest]

Protein is an Independent Risk Marker for Kidney and Cardiovascular Disease

Data published in the November 2004 supplement to the International Society

of Nephrology's Journal, Kidney International, showed the predictive power

of

albuminuria as a risk marker and therapy target for cardiovascular and

kidney disease.

The supplement, titled " Albuminuria: Risk Marker and Target for Treatment, "

included a broad array of research on the protein's predictive power as a

risk

marker and therapy target, its mechanism of action, and advances in how it

is measured.

The results showed that albuminuria is an independent risk marker for kidney

and cardiovascular disease not only in at-risk patients such as diabetics

but

also in the general population. Initial data also suggested that albuminuria

can serve as an independent therapy target, irrespective of cholesterol,

blood

pressure and other commonly used drug efficacy parameters.

Highlights of additional research presented in the supplement included:

- Microalbuminuria is associated with significant glomerularpathology and

increased renal as well as cardiovascular risk.

- Measurement of urinary albumin - before starting and during treatment -

may be a useful tool to identify both diabetic and non-diabetic patients at

high

risk of renal and cardiovascular disease.

- Combining the level of urinary albumin to the Framingham score results in

a highly efficient primary prevention strategy.

- Clinical trial results suggest that HPLC techniques identify more people

at risk especially when screening large populations. This article was

prepared

by Biotech Week editors from staff and other reports. Copyright 2004,

Biotech Week via NewsRx.com & NewsRx.net.