Drawing the attention of venture capitalists and national pharmaceutical corporations alike, Aciont Inc. and ZARS, Inc. are two up-and-coming Utah biomedical companies focusing on innovative noninvasive drug delivery techniques.

University of Utah pharmaceutical chemistry professor Dr. William Higuchi founded Aciont in 2000. Aciont is developing an innovative system for delivering drugs to the back of the eye.

Aging and diabetes can cause sight-threatening eye degeneration, says John Higuchi, Aciont president and son of the founder. “There are a lot of drugs available to arrest degeneration, but they have to be injected deep in the eyeball,” he says, noting that injection is not only painful, it is dangerous. “You can actually pop the eyeball out delivering some of the more viscous drugs.”

Dr. Higuchi has developed a system using an electrical current to drive molecules into the eye. “The main barrier for the delivery is the sclera, the white portion of the eye,” he says. “We’ve developed technology that provides significant enhancement of the flux [flow of drugs].” Other companies have attempted similar concepts, but Aciont is the one that has succeeded where others have failed. “We get up to about a five to tenfold flux enhancement — delivering five to 10 times the drug in the same amount of time.”

Aciont’s technology involves a small patch inserted under the lower eyelid. “You slip the patch on much like a contact lens,” says John Higuchi. “There’s a small wire running from the patch to a power source, not much different than a flashlight.” The drug is contained in the patch, and the electrical current causes the drug to be absorbed by the eye. “We’re looking at about a 10-minute treatment in the doctor’s office.”

Aciont’s strength is in its innovation. “What’s important to know is that this is not a ‘me-too’ company,” John Higuchi says. “There’s no other company that has a non-invasive system that can deliver drugs to the back of the eye.”

Thus far Aciont has been funded by Dr. Higuchi and by federal grants, but the company is looking for venture capital investors. Although Aciont’s product will not be available commercially for at least eight years, the time is ripe for developing this system now, says John Higuchi. The aging of America means a huge market for fighting age-associated eye disease, and pharmaceutical giants such as Pfizer are eager to meet the need. “Pfizer recently signed an agreement with an ocular therapeutics company to gain rights to specific product opportunities — the initial license fee alone for this deal was $100 million,” he says. “That is a strong reflection of how top pharmaceutical companies are committed to finding proper medicines for eye diseases.”

Salt Lake City-based ZARS, Inc., a biomedical company founded in 1996 and named for co-founders Jie Zhang, Ph.D., Michael Ashburn, M.D., Larry Rigby, and Theodore Stanley, M.D., is working on another innovative drug delivery system, enhancing the transdermal absorption of medicine with controlled heat.

“Our focus is to improve the delivery of existing drugs rather than discovering new molecules or drugs,” says Wade Hull, ZARS director of engineering. “We do that using heat. It’s similar to a chemical handwarmer, but with a precisely controlled temperature.”

“It sounds deceptively simple,” says Larry Rigby, ZARS president and CEO. “It’s well known that heat can affect the ability of the skin to absorb drugs into the body, but we are the first to patent the concept of controlled heat. We focused our development on some transdermal delivery techniques developed by Dr. Zhang.” The company uses its patented heat delivery system, called CHADD (Controlled Heat-Assisted Drug Delivery), in a number of products now in development.

The company’s first product is the S-Caine Patch. “Our first patch uses heat and an anesthetic to numb the skin” before painful medical procedures such as blood draws or pediatric immunizations, says Hull.

“Our second product is called the S-Caine Peel, an anesthetic cream that can be applied over larger surface skin areas. It dries to form a layer that can be easily removed or peeled from the skin,” Hull says. The cream will be particularly useful for painful cosmetic and dermatologic procedures such as hair removal, laser resurfacing, tattoo removal and port wine stain birthmark removal, he says. Both the S-Caine Patch and the S-Caine Peel are under license to Ortho-Neutrogena, a division of Johnson & Johnson.

ZARS also has in development a patch that combines fentanyl, a pain reliever more potent than morphine, with heat delivery. “Titragesia is the trade name,” says Hull. “It’s a systemic painkiller for very severe pain, such as chronic cancer pain.” The Titragesia patch delivers a constant amount of fentanyl over several days. But cancer patients have episodes of increased pain, called breakthrough pain. “The CHADD technology enables us to put the heating patch on top of the drug patch for a fast increase in the drug level. In less than five minutes you can get an increase of the drug level in order to treat the pain,” says Hull. “It’s one product that does two things — it gives a continuous level of drug to fight pain. But applying the heat patch on top of the pain patch gives a burst, or bonus dose, of the pain-relief drug.” Titragesia has been licensed to Cephalon.

In March, ZARS submitted a New Drug Approval (NDA) application to the Food and Drug Administration seeking approval of the S-Caine Patch. They plan to submit an NDA on the S-Caine Peel in November.

The NDA process is arduous, Rigby says. “Our NDA is a thousand pounds of paper on a pallet,” he says. “It’s thousands of pages. It’s really incredible. And this is a relatively small NDA.”

Rigby expects the S-Caine Patch to receive FDA approval in about a year. “We’ve been working on this product for more than five years, and we’re still a year away from being able to sell [it],” Hull says. “And people ask all the time why drugs cost so much money.”

All this research and development requires a lot of capital. Rigby is on a round of fund-raising trips right now. “We’ve raised $4 million, half of that from the founders,” he says. “We’re raising $25 million in additional funds.”

 “We’re a small start-up company. We’re still pre-revenue,” says Hull. But, notes Rigby, “We expect $26 million in the next four years in fees and royalties from our partners. It’s a very tough market to raise money in, but we’ve had a lot of interest.”

And that’s just the beginning. “We have about eight products in our pipeline,” says Rigby. “We’re definitely a high-energy entrepreneurial company. We’re able to move very quickly in product development.”

With Aciont and ZARS in the lead, noninvasive drug delivery is positioned to deliver a bright future.