When product designers at Palo Alto (Calif.)-based Ideo were brainstorming how to make a patch that can deliver vaccines through the skin, they considered some over-the-top ideas. The list of possible ingredients included tape, knives, even cactus needles. "The idea was to push the boundaries of what might be realistic," says Tad Simons, health practice leader at Ideo. "Sometimes you gain insights from crazy things."
Such insights could ultimately turn the centuries-old method of needle-stick vaccinations on its head. That's the dream of executives at Gaithersburg (Md.)-based biotech company Iomai (IOMI), which hired Ideo to develop flu-fighting patches and other vaccines. Iomai was co-founded in 1997 by Dr. Gregory M. Glenn, who has devoted his career to developing a procedure called transcutaneous immunization (TCI)—a pain-free method of delivering vaccines into the outer layer of skin known as the epidermis.
The idea of delivering medicine through the skin isn't new. Already patients can wear patches that prevent pregnancies, ward off motion sickness, and help them quit smoking. But those medicines are composed of small molecules, which pass through the skin easily. Vaccines, on the other hand, are composed of large molecules, making them much more difficult to transfer in this manner.
THICK SKINNED. So Glenn developed a way to target a part of the immune system called Langerhans cells, which reside in the epidermis. Once those cells are activated, they "orchestrate an immune response that becomes protective," Glenn explains. Sounds simple, except for one thing: Langerhans cells reside beneath a dead layer of skin that's so tough "it acts as a barrier to everything that tries to get in," says Iomai CEO Stanley Erck.
So to get vaccines to Langerhans cells, Iomai's scientists had to figure out how to rough up that barrier without causing patients pain or injury. The designers started with hundreds of ideas, several of which they made into prototypes and tested on themselves. "Some people looked like they had been in bike accidents," jokes Simons of the scrapes and bruises that the more aggressive patches left behind. "We had to abandon those."
Ultimately, Iomai tested more than 20 of the patch finalists on real guinea pigs. The company had tried the patches on the old research standby—mice—first, but the results were unreliable. "Their skin is so thin that everything worked," Erck says. "Guinea pig skin is almost like human skin. It's very hard."
SCRATCH AND PATCH. The winning design looks like a combination of a miniature pop-up children's book and a large Band-Aid. To prepare the skin, the clinician places the device on the patient's arm and pulls a tab—much like a child would slide a tab to make the characters in a pop-up book dance.
The tab draws a mildly abrasive substance across the skin, which makes a painless and nearly imperceptible dent in the protective layer. At the same time, it leaves behind an ink mark to show where the patch should be applied. The patient then wears the patch for several hours (the length of time varies depending on the vaccine).
Iomai executives believe that the patch's user-friendly design will catch the attention of the U.S. government, which has been looking for products that can be stockpiled and distributed during a much-feared outbreak of pandemic flu. With needles out of the picture, Iomai's product could allow patients to vaccinate themselves—eliminating the worry of overcrowded emergency rooms and overwhelmed physicians.
AHEAD OF THE GAME. "It's possible to develop a patch that could be warehoused and FedExed to 100 million people overnight," Erck says. In September, Iomai will learn whether it is one of the handful of companies expected to share $150 million in grant money that the government has set aside for pandemic preparedness research.
Other companies, including giants such as GlaxoSmithKline (GSK) are developing new ways to deliver vaccines, and Glenn suspects a number of competitors are interested in the patch technology. But he's hopeful Iomai's strong patent portfolio and long head start will give it an edge. "We don't know of anyone who is as far along," he says.
BIG NUMBERS. Iomai has several more hurdles to clear. It will spend the next couple of years testing its flu patch in people, so it can prove the product produces at least as good an immune response as the standard injected vaccine. The company is also testing a patch to prevent traveler's diarrhea, an unpleasant condition that afflicts so many tourists Erck estimates the product could bring in $500 million a year in sales.
But the real goldmine will be pandemic flu. The dollar value of that market, says Cowen & Co. analyst Ian Sanderson, "is guesswork. But we expect government stockpiling, maybe 150 million doses at $4 a dose. The numbers could get even larger than that." Sanderson estimates that Iomai, which went public in February, will begin posting sales and profits in 2009. And not a single cactus needle will have been sacrificed along the way.