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[IP] Minimed Article in NY Times Today
Minimed Chief Aims to Change Diabetes Therapy
By ANDREW POLLACK
OS ANGELES -- Alfred E. Mann has founded six companies. He has pledged
$100 million each to the University of Southern California and the
University of California at Los Angeles to build biomedical research
institutes. He has numerous inventions to his credit.
But can he capture the Holy Grail of diabetes monitoring?
Later this month, Mann's main company, Minimed Inc., is scheduled to go
before a Food and Drug Administration advisory panel to seek approval to
sell the world's first sensor that provides continuous measurements of
glucose in the blood.
Right now, to measure blood sugar, diabetics have to prick a finger and
draw blood several times a day. Minimed says its system will be less
painful and will provide more detailed information, allowing diabetics
to better control their condition and improve their health.
"It's going to change the whole paradigm for diabetes therapy," Mann
Some analysts and physicians say such promises are exaggerated, arguing
that the sensor's probe lasts only three days and will appeal to only a
tiny percentage of diabetics.
But that has not deterred Mann, who at 73 puts in 80-hour weeks at
Minimed, two other companies, a nonprofit research foundation, venture
capital activities and the USC and UCLA projects.
The sensor is just a step toward Mann's ultimate goal -- a mechanical
pancreas in which a pump would automatically dispense the right amount
of insulin in response to blood glucose levels detected by the sensor.
"When you have an automatic system, the patient won't even know he has a
disease," said Mann, Minimed's chairman and chief executive.
A prosthetic pancreas still is years away. But the sensor alone is
generating excitement not only among patients and doctors but among
investors. Shares of Minimed have surged from less than $60 in November
to $100.25 at Wednesday's close.
"I've been jokingly calling it Minimed.com," said Melissa Wilmoth, an
analyst with Salomon Smith Barney, another Minimed underwriter.
Also helping the stock is the fact that revenues for Minimed's main
business -- selling insulin pumps -- are now growing 50 percent a year.
As the dominant domestic supplier, the company is viewed as a takeover
But what the company has going for it most, perhaps, is its chief.
Mann has spent his career moving from company to company almost by
happenstance. After studying physics at UCLA, he started two aerospace
companies, Spectrolab and Heliotek, which were both sold to Textron and
are now owned by Hughes Electronics, a unit of the General Motors Corp..
Because of his work making power supplies for satellites, scientists at
Johns Hopkins University asked him in 1969 to work on longer-lasting
batteries for pacemakers. So Mann founded Pacesetter Systems and
introduced rechargeable pacemaker batteries. He sold the privately-held
Pacesetter to Siemens of Germany for $150 million in 1985, without using
an investment banker or even telling his chief financial officer.
Pacesetter is now owned by St. Jude Medical Inc. and is the No. 2
pacemaker supplier, behind Medtronic Inc.
In 1979, as head of Pacesetter, Mann was visiting a cardiac ward at the
University of Alabama at Birmingham. His host, the heart surgeon Dr.
Richard B. Shepard, remarked that diabetes seemed to have contributed to
cardiovascular problems in many patients. He challenged Mann to work on
"I really lit into him," recalled Dr. Shepard, who has not kept up much
with Mann recently. Informed of Mann's efforts with the glucose sensor,
Dr. Shepard said: "He took it to heart. I didn't realize he did."
Besides Minimed, which was spun off from Pacesetter in 1985, Mann
started and controls the Advanced Bionics Corp., which makes implants
that allow deaf people to hear, and Medical Research Group Inc., which
is doing research on the artificial pancreas for Minimed. All the
companies are next to one another in Sylmar, Calif., north of Los
Mann is also chairman of the Southern California Biomedical Council, a
group that is trying to spur greater development of the biotechnology
industry in the Los Angeles area. Not content to wait for committees,
Mann seems to be taking the job into his own hands. He is working on
three new technologies that could spawn three new companies, associates
say. He is also investing in start-ups formed by others, like CTL
Immunotherapies, a Canadian company he is moving here.
All this, of course, keeps Mann busy. He rarely takes vacations and says
his main hobby is "designing for fun" -- not only medical devices but
contraptions like the water-conserving hydraulic gates at his Los
"Many people ask me why I work so hard," Mann said. "I work so hard
because I don't work at all. I play all day." He added, "How can you get
more reward than giving somebody his life or improving his quality of
Still, zeal might not be enough for the glucose sensor.
Numerous companies have promised but failed to deliver sensors that were
painless, continuous or both.
Other competitors are hot on Minimed's tail. Cygnus Inc. of Redwood
City, Calif., hopes to apply to the FDA by June for permission to sell
the Glucowatch, a wristwatch that would take a glucose reading up to
three times an hour. Spectrx Inc. of Norcross, Ga., also recently
demonstrated a continuous sensor, though an FDA filing is probably at
least two years away.
Some companies say that for the vast majority of diabetics, eliminating
the pain of finger pricks is more important than a continuous glucose
reading. Cell Robotics International of Albuquerque, N.M., and Amira
Medical of Scotts Valley, Calif., recently won FDA approval for systems
that, while not continuous, are advertised as less painful.
Diabetics either cannot make or cannot properly use insulin, a hormone
produced in the pancreas. Insulin is needed to turn the sugar in food
What is driving the quest for better sensors is that a major clinical
trial, completed in 1993, found that diabetics who kept their blood
sugar as close to normal as possible significantly reduced their risk of
complications like blindness, kidney failure and the need for
In that trial, patients measured their blood sugar levels four to seven
times a day. But Minimed says that even seven measurements can fail to
detect instances when blood sugar shoots way out of normal range. Data
from the continuous sensor "will show how poorly controlled most people
with diabetes really are," Mann said.
Some doctors agree. "People for the first time will have many readings
of their blood sugar," said David C. Klonoff, a clinical professor at
the University of California at San Francisco, and editor of a new
journal called "Diabetes Technology and Therapeutics."
With more frequent readings, diabetics could fine-tune their insulin
intake or take other steps like forgoing part of a meal if they see
their glucose level rising.
David Hitchcock, who runs www.childrenwithdiabetes.com, a
diabetes-related Web site, said the main benefit of a continuous sensor
would be the ability to sound an alarm when blood sugar drops too low,
which can cause patients to lose consciousness. Hitchcock's 11-year-old
daughter, Marissa, who has diabetes, now has to be awakened every night
and have her blood sugar tested.
The Minimed sensor uses a replaceable probe to measure glucose in the
fluid directly under the skin, usually in the abdomen. One question the
FDA will consider is whether measurements in this fluid can adequately
substitute for measurements of the blood itself.
Some experts say many diabetics will not want to have anything
permanently attached to them or wear a device that tells the world they
have the disease.
The Cygnus Glucowatch, by contrast, sits on top of the skin and uses
tiny electric shocks to open up pores and extract fluid. But while
perhaps more socially acceptable, the Glucowatch has had development
problems, and Becton Dickinson & Co. last year pulled out of an
agreement to market the device.
Other experts say that relatively few diabetics will be able to take
advantage of the extra information a continuous sensor can provide.
"It's just overkill," said Dr. Xavier Pi-Sunyer, a professor of medicine
at Columbia University.
Only about 1 million of the nation's estimated 16 million diabetics have
Type 1 diabetes, the form that generally requires insulin injections. Of
these, only 20 percent to 30 percent now intensively regulate their
blood sugar levels.
Because of concern that patients might not know how to use so much data,
the first Minimed sensor will not even show glucose readings. It will
store the information to be downloaded later by doctors for analysis. A
second version will sound an alarm for low glucose levels. If those
prove successful, a meter that can be read by patients would follow.
Similar concerns have hindered the adoption of insulin pumps, which also
require the patient to insert a catheter under the skin and wear a
pager-like device. About 60,000 insulin pumps are now in use in the
United States, representing only about 6 percent of Type 1 diabetics.
But pump use is growing rapidly as many people rave about them. Nicole
Johnson, the current Miss America, wears a Minimed pump.
Minimed, with total sales of $138.6 million last year, dominates the
U.S. pump market with a share above 75 percent. It has only one
competitor, Disetronic Holding AG of Switzerland, which dominates the
Mann, the son of a grocer, is not used to failure, except perhaps in
music. His brother, Robert, founded the Juilliard Quartet, and his
sister, Rosalind Koff, is a concert pianist. But Mann's piano is played
by a personal computer.
He also has failed so far in getting UCLA to accept his $100 million.
While USC is moving ahead with its research institute, to be named for
Mann, UCLA and Mann have not agreed on terms.
"If they don't do it by summer, maybe I'll do it with Johns Hopkins
instead," Mann said. He said he was considering similar ventures with
Hopkins, Harvard and the University of California at San Francisco.
"My whole estate will go to these ventures," he said, adding that his
six children already "have enough." Fortunately for the lucky
universities, that estate keeps growing. His 34.4 percent of Minimed
alone is now worth about $500 million.
Insulin-Pumpers website http://www.insulin-pumpers.org/