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[IP] Re: Finding a cure?

An article from Diabetes in Control that lends a viewpoint to our discussion:

 bThe Perfect Diseaseb

Diabetes has no cure, and it consumes 1 out of every 7 health care dollars
and adds up to over 100 Billion dollars a year.

Diabetes is big business with 25% of our Medicare budget going towards
treating it and with an increase of over 70% in the 30 year olds and 30%
increase in teenagers with diabetes over the last couple of years and it is
going to get even bigger.  The American Diabetes Association (ADA) says Type
2 diabetes is nearing (it actually is) epidemic proportions because Americans
are aging, getting fatter and are more sedentary.  At greatest risk; lazy,
fat people over 30, with a family history of diabetes.  Diabetes is one of
the most costly health problems in the US and in the world b with a tab of
over 100 billion dollars and growing in the US alone.

Diabetes drugs, the fastest growing category, cost $3.5 billion a year.  But
then there are diagnostic systems, delivery systems, needlesb&b&b&

There is no cure and it is a progressive disease, and as the UKPDS has shown
us, no matter what you do, it will always get worse over time.   So when a
doctor prescribes a drug, we know it will fail eventually.   As long as we
treat the complications from diabetes, it will continue to be a drain on our
healthcare industry, but a boom to our economy.

It is a perfect disease from a business perspective because patients need a
large and steady supply of drugs, diagnostic and delivery devices and lots of
disposables like lancets, syringes and test strips, among other things.
Diabetics are very receptive to any technology that makes life simpler and

It is a perfect disease from a medical professionals perspective because once
you have a diabetic patient and you build a relationship, you can have that
patient for life who makes an office visit at least 2-12 times a year.

It is a perfect disease for the patient because the patient controls 95% of
the outcome.   It also causes the patient to become educated about their
disease in order to control it and if they do everything right,  they will be
in better health then 90% of the people in their age group.

There is a race not to cure or prevent the disease but to market products to
treat it. Diabetes has attracted an array of players, from large drug makers
to companies working on new drugs with milder side effects, to companies
wanting to deliver insulin via painless needles, orally or into the lung, to
device makers with better insulin delivery pumps, to companies making
diagnostic and continuous monitoring tools.

The field is crowded but the investment potential is massive and itbs tied
solid growth trends, this is big business.  At 6% and growing and 16 million
Americans and 100 million diabetics worldwide and 2,200 new diabetics are
diagnosed every day in the U.S. so,  800,000 will be diagnosed this year in
the US alone says the ADA.  That means an additional 5 billion dollars spent
every year in just medications and supplies.

The ADA reports 10.3 million diabetics have been diagnosed, but an additional
5.4 million people have it and donbt know.  One day they will.  Then they
will be faced with spending $2,500 to $3,500 dollars a year on needles,
drugs, insulin and blood testing strips.  For 50% of those that get
diagnosed, they would have had diabetes for up to 12 years before and will
already have signs of the complications, which will mean even more expenses.

The total annual economic cost of diabetes in the US alone in 1997 was 98
billion dollars.  That included $44 billion in medical costs.   The other $54
billion is the indirect costs of disability and mortality.

The top pharmaceutical companies dominate the field with billion-dollar
diabetes drugs.

Bristol-Myers Squibb makes the insulin sensitizer drug Glucophage.  Itbs
mainly by the older population for Type 2 diabetes and had sales of $1.3
billion in 1999.  They are also co-developing Basulin, a form of long-acting

Eli Lilly makes insulin and the Type 2 insulin sensitizer drug Actos, which
was launched in August 1999 and racked up sales of $147 million in its first
five months.

SmithKline Beecham introduced the insulin sensitizer drug Avandia in June

Novo Nordisk makes and sells insulin as well as the insulin secretion drug
Prandin and is soon expected to launch NovoLog, a fast-acting insulin.

Pfizer makes the sulfonylureas Glucotrol and Glucotrol XL.  Sulfonylureas are
a $500 million- a b year class of drugs that help the body produce more
insulin.  Pfizer now owns Warner Lambert, the maker of the antidiabetic drug
Rezulin, which was the first insulin sensitizer, which was launched in 1997
and posted annual sales of $625 million.  In March 2000, the drug was
withdrawn for causing liver damage.

Aventis also makes two sulfonylureas, Amaryl and Diabeta, as well as insulin.
 It is soon to launch a new insulin product Lantus, a biosynthetic insulin
that mimics human insulin and will last for 24 hours.

Novartis is planning a 2001 launch for Starlix, a new drug for Type 2
diabetes which is similar to Prandin and just received FDA approval last

At least 3 companies are working to deliver insulin without needles.  Aradigm
is collaborating with Novo Nordisk to develop inhaled insulin.  Inhale
Therapeutics considered the leader in deep-lung drug delivery, is developing
inhaled insulin with Pfizer.  Eli Lilly has an agreement with Dura
Pharmaceuticals to develop inhaled insulin.

Canadian-based Generex Biotechnology is developing orally delivered insulin
that appears to deliver at levels on par with injections.  The insulin will
be delivered through the lining of the check  they believe it is possible to
get an accurate dose via a mouth spray.  The drug takes effect within 10
minutes of use.  The company says it found no adverse reactions in tests and
is now doing trials on Type 1 and 2 diabetes in the US and Canada.  They just
completed a $23 million private placement and will use the money to expand
the trials.  In September it entered into an agreement with Eli Lilly for the
oral formulation.

Abbott Labs is the largest of the diagnostic and medical device companies
working on diabetes.  Abbott makes precision glucose meters and is
co-developing a continuous glucose monitor with SpectRX.  The monitor will
regularly check the personbs blood to see how much, if any,  insulin is
needed.  Inverness Medical Technology also makes devices and disposable
products for diabetes.

Becton Dickinson makes insulin delivery products b needles, lancets and
syringes b all items used daily by millions of diabetics.  It is the biggest
producer by far.  Its products could be duplicated and sold more cheaply
through private labels but it has effectively kept competitors out of major
distributions with restrictive market agreements.  But some of the chains
like Walgreens and Walmart have committed to private labeling.

Amylin Pharmaceuticals, Alteon, OSI Pharmaceuticals and Insmed are working on
new classes of drugs for diabetes.  Mini-Med and Cygnus are working on
glucose monitors.

MiniMed controls 85% of the market for pumps but Disetronic a swiss firm and
Animas a US firm are making inroads and will heat up the competition for the
insulin pump market which is growing at the rate of 80% a year.  Pumps right
now are the only available treatment that provides insulin continuously b
preferred way.  The cost of using a pump is per year is about $700 compared
to the $1200-$2400 for injections and other conventional approaches.  The
Pumps sell for over $5000, but lasts for years MiniMed also markets a
continuous glucose monitor, but there are at least 5 other companies doing
research on their own continuous glucose monitor.  One of those is a company
that is developing a continuous glucose monitor that is implanted and works
for over a year and sends readings to a computer.  All of these companies are
working on a continuous loop insulin pump, where a monitoring device measure
the amount of glucose in the blood and sends the information to the pump to
give you the exact amount of insulin your body requires, just like your own
pancreas, but you will be wearing it.

Inverness Medical Technology makes blood glucose monitors, glucose test
strips under its own brands and for private label retailers as Rite Aid,
Walgreens and Wal-Mart

Johnson & Johnson make the Lifescan products and holds the competitive edge
in blood glucose monitors and strips.  Bayer labs, Abbott Labs, Roche
diagnostics, and LXN Corp are all trying to eat in to their market share,
spending millions in advertising and R & D.

Cygnusb GlucoWatch is all the rage in continuous glucose monitoring.  The
wrist-worn device monitors blood-sugar levels and gives readings every five
minutes.  Its electro-osmosis system checks the patientbs blood-sugar levels
without breaking the skin, a huge benefit.   The FDA is deliberating on the
product now, but customers will be disappointed with how the product works.
Among the drawbacks, is a 3-hour warm-up period.  The watch must also be
calibrated before use with the patientbs blood, this means finger sticks
using lancets.  High and low readings have to be confirmed with tests on
other devices, so more finger sticks.

One of the newest concepts in continuous glucose monitoring systems is being
developed by SpectRx who has an agreement with Abbott to market the system
when it gets approved.   Its products use biophotonic technology based on
light beams to make medical diagnosis.  The plan is to have a single-use and
continuous glucose-monitoring device that uses lasers and vacuums to
penetrate and remove fluid through the skin.

Amylin Pharmeceuticals is developing diabetes drugs based on the hormone
amylin, which is believed to play a role in metabolic controls.  The company
develops Symlin for Type 1 and insulin-using Type 2 diabetics.  It completed
phase III trials for Symlin and plans to apply for FDA approval by the end of
2000.  But in October, Amylin successfully completed the feasibility stage of
its collaboration with Alkermes for the development of an injectable
long-acting release formulation of its drug AC2993, for Type 2 diabetes.  The
goal is a formulation that would allow once-a-month administration.

Insmedbs main candidate INS-1, an oral formulation, fights Type 2 diabetes
and polycyctic ovary syndrome, which cause infertility in women.

Genomics companies are also targeting diabetes.  Lynx Therapeutics and
Genomics Collaborative will be doing a comprehensive genome-wide scan for
single nucleotide polymorphisms, or SNPs, that are associated with Type 2
diabetes.  These SNP markers could lead to the discovery of diabetic gene
targets and pathways, as well as diagnostic markers for the onset and
progression of Type 2 diabetes.  This will allow us to due preventative
medicine and help to prevent those that will become diabetic.

These are most of the major players in the diabetes field, but there are many
more small companies that are working to develop products for people with

Is this the perfect disease?

Steve Freed, R.Ph., CDE

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