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[IP] Biotech companies race to develop alternative to needles

>From the King 5 TV website:

Biotech companies race to develop alternative to needles

Associated Press

SAN FRANCISCO - Everybody hates needles.

Millions of diabetics aggravate their disease by skipping insulin
injections. Countless Americans would rather risk the flu than get
inoculated against the virus each year.

Seeing financial promise in this fear of the needle, several biotechnology
companies are scrambling to develop alternative delivery systems, including
inhaled versions of injectable drugs.

Gaithersburg, Md.-based MedImmune Inc. is hoping the Food and Drug
Administration will approve its nasal spray flu vaccine in time for the
upcoming flu season.

Many doctors have eagerly awaited the spray vaccine, saying the pain-free
method would encourage more vaccinations.

Each year, about 70 million get today's flu vaccine, a shot in the arm. Yet
influenza still kills 20,000 Americans and hospitalizes about 100,000
annually, according to the Centers for Disease Control and Prevention.

Young children in particular are the primary transmitters of flu to parents,
grandparents and caregivers, yet they rarely receive annual shots.

In the San Francisco area, Inhale Therapeutics Systems Inc. and Aradigm
Corp., along with their respective pharmaceutical partners, are racing to
get their versions of inhaled insulin approved by the government.

If one or both companies succeed, analysts and biotech executives believe
drug makers will try to convert other injectable drugs, including cancer

Such a breakthrough would not only make patients' lives easier, it could
prove to be a big boon for the biotechnology industry itself.

Most biotechnology drugs on the market or near approval must be injected.

One reason: The nascent industry devoted most of its resources to developing
novel therapies and paid little attention to drug delivery. Also, most
biotechnology drugs involve bigger molecules than traditional medicines, so
they require injections.

"This has kept in check a lot of growth in the biotechnology industry," said
San Carlos-based Inhale chairman Robert Chess. "There aren't very many
big-selling drugs that are injectable."

One exception is insulin.

An estimated 17 million Americans suffer from diabetes, though up to six
million are undiagnosed. Not all diabetics require insulin injections, but
the drug rang up $3.6 billion in sales last year. Needle-free insulin could
double annual sales by 2006, some optimistic analysts predict.

Most of the growth will come from the estimated four million diabetics who
should inject insulin but don't because of aversions to needles, Chess said.

Furthermore, diabetes is growing faster than the general population, with
almost 800,000 new cases diagnosed each year in the United States.

Inhale, Aradigm and several other companies developing similar products
believe they can grab a big share of that market - while encouraging more
diabetics to stick to their insulin regimen.

"If proven safe, they will be very broadly adopted," said analyst Ian
Sanderson at S.G. Cowen Securities Inc. "A lot of diabetics are going to
adopt this very quickly."

Still, convincing the FDA that inhaled insulin is safe and effective has
proven tougher than expected.

Inhale's partner, Pfizer Inc., announced in July it would delay filing for
FDA approval this year as planned. The pharmaceutical company said it would
conduct additional safety tests.

Aradigm and its Danish partner, Novo Nordisk, earlier this month launched a
planned two-year human trial. They hope the results will persuade the FDA to
approve their product.

The delays have spooked the biotechnology companies' investors.

Inhale's stock trades in the $6-a-share range, far off its 52-week high of
$20.25. Aradigm's stock price hovers around $2.25 a share, less than a third
of its 52-week high of $7.42.

One major concern is the long-term effect inhaled insulin will have on the

The companies insist their products are safe and will ultimately win
approval, but they'll still have to convince the public.

"I'm skeptical until proven otherwise," said Kristy Meanor of Wetumpka, Ala.
Meanor's 9-year-old son, Drew, is diabetic and must constantly wear a
beeper-sized "pump" taped to his hip to feed insulin through a tube.

Meanor said she would need overwhelming evidence that inhaled insulin is
safe before allowing her son to use it.

Still, Meanor does hope somebody succeeds.

"I'm really anxious for something more flexible, something to give my son a
break," Meanor said.
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