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The EpiCard Epic
Intelliject's auto-injection
device for treating food allergies is shaping up to be a
blockbuster. And it's just the first
of many promising products likely to flow
from the Richmond lab.
by
James A. Bacon
Intelliject,
LLC, finds itself in an enviable
position right now. Although the
fledgling company still needs to
file a New Drug Application with
federal regulators for its product, the EpiCard,
and then await agency approval, it has giant
pharmaceutical companies standing in line to do business. The
biggest challenge the company faces
right now, says CEO Spencer
Williamson, is picking the right
partner.
That's a lot of
due diligence for a 10-person firm.
"It's the kind of problem a lot of
people would like to have,"
Williamson says. "But it's still a
problem."
Truly, most
start-up businesses would
love to have Intelliject's problems.
So vast is the market for the
EpiCard -- millions of Americans
suffering from severe allergies need a device that can make
emergency injections of epinephrine
-- that Intelliject is in a position
to command up-front payment for
rights to license the product before
it has even won FDA approval.
Even more
enviable, unlike most
companies that have developed a new
drug or medical device, Intelliject
has not struggled to raise capital.
The first three rounds -- family &
friends, angel, institutional --
will largely suffice. Instead
of raising cash to build a large organization, Intelliject will use royalties from
the EpiCard to underwrite
development of follow-up products.
Says Williamson: "We may put a
little more capital in at some
point, but we have been blessed from
the start with significant interest
and access to value-add capital."
Richmond has
never seen anything quite like
Intelliject. Local life sciences
ventures have raised tens of millions of
dollars in outside capital, and some
companies have shown modest success,
but no business has come so far, so
fast. And none have the seemingly
blue-sky potential for limitless
growth.
Williamson and
the company's two 28-year-old
founders, identical twins Evan and
Eric Edwards, are looking already to
their next projects. The technology developed
for the EpiCard, which is tightly
protected with more than 50 patents,
can be used to deliver medicine for
the treatment of asthma, multiple
sclerosis, rheumatoid arthritis and
the symptoms of chemotherapy. Also,
there
are potential applications for biodefense, the military and
pandemic preparedness like the avian
flu.
"We feel like
we were divinely brought together,"
says Williamson. "There is no
challenge we can't get over. Every
challenge is meant to be. It's part
of the journey."
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Eric (left) and
Evan
both have suffered from severe food allergies
-- egg products, seafood, tree nuts,
peanuts -- since they were children.
Evan has had two close calls.
In one incident, he accidentally
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ingested nuts mixed with hummus at a
northern Virginia restaurant. He
didn't have an epinephrine auto-injector with him. Within
minutes, his lips and throat began
to swell as his body slipped into
anaphylactic shock. He was saved by
being rushed to a local hospital.
Native Richmonders,
the Edwards lads decided to devote their lives
to
developing solutions for people
suffering the same infirmity. Evan
obtained a masters degree in systems
engineering at Virginia Commonwealth
University, with a concentration in
human factors engineering, while
Eric studied clinical disease
management at VCU's Medical College
of Virginia as a MD/PhD candidate.
At age 26, the Edwardses were far
enough along in the development of
an EpiCard prototype that they could
start building the company. Their key hire
was Williamson, a Virginia Military
Institute grad with an MBA from
Chapel Hill who had risen through the
ranks at pharmaceutical giant Eli
Lilly and medical device
manufacturer Guidant Corporation.
For some three
decades, people who suffer severe
allergies have had the option of
only one portable auto-injector: EpiPen, an
outgrowth of NASA
technology produced by Napa, Cal.-based DEY L.P.
While EpiPen has helped patients for
27 years, in Williamson's estimation
the product has
several drawbacks.
First, it's
fairly large: not so bad for an
adult, but a major inconvenience for
children. (Only a third of severe
allergy sufferers consistently carry
auto-injectors with them.) Second is safety: once the EpiPen is used, the needle
protrudes from the tube, where it
can jab someone. Third is the ease
of use. It's one thing to pop off
the cap, extend the needle and jam
it into your thigh when your mind is
clear. It's quite another when your
blood pressure is plummeting, your throat is constricting
and you're losing your cool.
The EpiCard is
designed to be more compact than EpiPen, making it
easier for a child to carry in a
pocket.
Furthermore, the needle retracts
when it has been used, eliminating
the potential for accidental sticks. Most
imaginatively, the EpiCard bears a
voice chip that walks the patient
through the administration
of the epinephrine step by step.
"It's small,
it's simple, it's safe," says
Williamson. "We've put this in the
hands of people who've never used it
before. They've used it
appropriately."
Those
differentiators should be sufficient to
give EpiCard a big competitive advantage
in the marketplace, but the Intelliject team is working on yet
another. The shelf life of epinephrine in auto-inject
devices is about 18 months. Trouble
is, there's no way to tell if the
drug has gone bad. "People forget
the darn things have expired,"
Williamson says. Intelliject is
working on an epinephrine formulary
that will last longer -- and a
device that will tell patients when
it's time to replace the unit.
The auto-injection
market for allergy sufferers is immense.
According to Wikipedia, between 1.2 and
16.8 percent of the U.S. population is
considered "at risk" for having an
anaphylactic reaction. Of those who
actually experience anaphylaxis, up to
one
percent may die as a result.
In other words, according to Williamson,
on average five Americans die every day from the
syndrome. And the
problem appears to be getting worse --
perhaps as a result of American
society's hyper-sterile environments and children's
lack of exposure to germs that would
build up their immune systems.
EpiCard is intended
to do more than save lives, Williamson says.
It will provide peace of mind. "People
live in fear when they go to a
restaurant or a friend's house. What if
the mother is making sandwiches and uses
the same knife on peanut butter as the
mayonnaise?"
Williamson cites a study that compared
the quality of life of diabetics to
people with food allergies. Even though
diabetics have to inject themselves
every day, they enjoy a better quality
of life. "He feels in control. The
food-allergy person doesn't."
Putting patients in control -- that sums
up the company's mission. "Our vision,"
says Williamson, "is to revolutionize
health care by designing patient-centric
pharmaceutical products that empower
patients to control, and gain freedom
from, their medical condition."
A key
element of Intelliject's strategy is to
run a lean, capital-efficient business.
"We're a semi-virtual organization," says
Williamson. "We have partners all over
the world on the manufacturing side, the
drug development side. I was in Eastern
Europe last week."
The trick
is picking the right partners and
executing the plan through them. "It's a
lot of work," Williamson says. "You have
to manage a lot of partners. I think we
do a pretty good job with that, but it's
not easy." On the positive side, the
strategy allows Intelliject to stay
small and focused on what it does
best: product development.
To excel
at its core mission, Intelliject is
recruiting top people from around the
world to staff the company. "Our
philosophy on people is this: If you're
going to build a world-class company,
you have to have world-class talent,"
Williamson says. That means persuading
people, who could
live anywhere they want, to pick up and live in Richmond,
Va. Fortunately, that has not been a
problem.
The firm's
downtown location, in the First Market
Bank building, is "dynamite." It's right
off the canal, with lots of sights,
sounds and tastes all around. The
company flies in the recruit, puts him
in a hotel on Shockoe Slip and sells the
city's quality of life. The most recent
hire, says Williamson, just moved here
from Zurich, Switzerland. "He's bought a
house in Glen Allen and has two kids at
Steward School. He's fired up."
"We love
being here," he says. We are an hour and
a half from the FDA and some of the best
regulatory consultants in the world.
We're two-and-a-half hours from the
Research Triangle," where Intelliject
interacts with companies and
consultants.
Everything
seems to be going Intelliject's way
at the moment and Williamson could
hardly be more up beat.
"This thing is smelling like it's going
to be pretty valuable," he says. "We
openly talk about it, if this business
is wildly successful, we want to stay
together and do things that impact, and
help, people."
What could
be more fulfilling?
-- October 7,
2008 |
