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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Saul H Rosenthal who wrote (2339)5/10/1998 1:41:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
From the Sunday Times, Diabetics to take insulin by inhaler
May 10 1998
INNOVATION

A device similar to the inhaler used by asthmatics could
avoid the pain of daily injections for millions of
sufferers, writes Sean Hargrave

Medicine

DIABETICS could soon be swapping needles for insulin
inhalers, similar to those used by asthmatics.

If current trials of new drug-delivery technology are
successful, the inhalers could save the 370,000 Britons
who rely on insulin, the pain and inconvenience of daily
injections. Worldwide, about 35m sufferers are estimated
to need daily injections of insulin, which must also be
carefully stored and kept refrigerated.

The impetus behind the new device came from a discovery
in the 1980s at Cornell University, New York. Carl
Leopold, a researcher, found corn and soya-bean seeds
survive dry conditions by storing sugars in a glass state.
When rains arrive, the sugar dissolves and energy is
released for the seed to grow into a plant.

"It is a great example of nature's ingenuity at finding a
means to store energy," says Leopold.

"I used the process to patent a means of storing molecules
in a glass state so they can be kept at room temperature
and only be dissolved when they come into contact with
water."

The discovery is now being used by Inhale Therapeutic
Systems in California to design new versions of existing
drugs centred on proteins. The molecules are normally so
large they can only be injected into the bloodstream but the
American company has developed a means of using the
Cornell discovery to "spray dry" medicines so they are
turned into a powder of fine granules.

The most advanced of the 11 projects is insulin. The
company targeted diabetics because it says people who
endure regular injections are the perfect market for a
system that will allow drugs to be inhaled.

Inhale Therapeutics is working with Pfizer, the
pharmaceuticals giant.
The companies say trials carried out
on more than 200 diabetics show that the new powder
form of insulin has proven to be as effective as an injection.

The partners are planning a third stage of trials before
approval is sought from America's Food and Drug
Administration. If the process is successful, the insulin
inhaler could be launched in 2001.


The insulin doses would be kept in foil packets and placed
inside a compartment in the inhaler.

The foil is essential protection for the drug because the
powder is so fine the slightest gust of wind would blow it
away. When the compartment is closed, the foil covering is
punctured.

The user then presses a button, just as with an asthma
inhaler, to prompt the device to suck in air, compress it
and then shoot a jet through the fine powder. The release
of compressed air should give the drug enough momentum,
as the user inhales, to reach the lower part of the lungs.

According to Joyce Strand of Inhale Therapeutics, much of
the research undertaken so far has been to find out the
optimum size of each granule.

"If they're too small, they get inhaled and then blown out
again, like smoke," she says. "If they're too big they get
dissolved in the mouth and throat before making it to the
lungs. We need them to get right in to the lungs because
this is a natural gateway for them to get into the blood
system and start working. After tests, we found that the
best size for the granules is between three and five
microns."

The lungs have been chosen as the quickest route to the
bloodstream. This overcomes the problem faced by
companies developing insulin pills and implanted pumps,
which have difficulty getting the insulin to cross the stomach
wall lining or fatty tissue.

The insulin inhaler resembles models used by asthmatics. It
is 6in long but it must be extended, like a telescope, to 12in
before it can be used. If the trials of the inhaler are
successful, it could be launched in Britain in 2001.

Other conditions the company is working on include
osteoporosis, hepatitis, fertilisation treatments and
delivering human growth hormones to stunted children.

"There are so many conditions that require regular
injections, and research all over the world shows that
people are afraid of the needle," says Strand.

"We believe we can provide inhalers that do the job just as
well, which should stop people seeking medical help on the
basis it might result in painful injections."