Friday, March 16, 2007

Patch work

Gaithersburg biotech pins hopes on new ways to deliver vaccines

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Photo illustration by Dan Gross
Gaithersburg biotech Iomai Inc. has won a $128.4 million federal contract to enter its immune-boosting skin patch into human trials. The patch delivers a bird flu vaccine through the skin and could provide a way to store and distribute the vaccine in the event of a pandemic.
For an emerging biotech, Iomai’s business plan is straightforward: Save millions of lives worldwide and safeguard the nation against pandemic flu while exploiting a $3 billion-a-year market.

The 10-year-old Gaithersburg company took a significant step toward that ambitious goal last month when it finally got its ‘‘company maker,” as founder Gregory Glenn put it: a federal contract worth up to $128.4 million to get into human trials its immune-boosting skin patch for bird flu vaccines.

The government hopes Iomai’s ‘‘ouchless” patch — similar to a Band-Aid, Glenn said — will provide the nation with a ready supply of bird flu vaccine in case a pandemic threatens. When the Department of Health and Human Services awarded the contract to Iomai, it also awarded bird flu vaccine contracts to pharmaceutical giants GlaxoSmithKline and Novartis.

‘‘That’s good company to be in,” Glenn said, ‘‘and it’s a company maker for us.”

Annabel Samimy of global financial firm UBS, agrees.

‘‘We view this as validation of Iomai’s ultimate goal of establishing broad utility,” Samimy said. As a result, a UBS report predicts Iomai will turn a profit by 2010.

Also working on developing various medical patch treatments are BioElectronics Corp. of Frederick, Sequella Inc. of Rockville and British firm Shire Pharmaceuticals, which has a plant in Owings Mills.

Saving children from flu

Delivering a bird flu vaccine isn’t its patch’s only application, Iomai says. Its patented technology is also suitable for better protection than injected vaccines against seasonal flu in the elderly and in millions of infants and children in developing nations. It also can quickly adapt to changes in influenza strains, either seasonal flu or bird flu, company officials say.

Unlike injected vaccines, the Iomai patches do not require refrigeration. They are made of dead virus antigens that are dried and will not spread to other people if exposed to the air.

Using a patch, health care workers in developing countries would not need special training to immunize a population, Glenn said.

‘‘We want to break the refrigeration chain,” he said. ‘‘It would make it possible to do a mass immunization campaign without having everyone go to a central city.”

Another advantage of the patch: It cuts the amount of flu vaccine needed to confer immunity by 90 percent, he said.

‘‘We are trying to make enough for everyone in advance,” Glenn said. ‘‘So if you can make a smaller dose — let’s say you can normally make 10,000 doses — you can decrease the dose by ten-fold and have 100,000 doses. So our patch, added at the time of a pandemic, would be a dose-sparing effort.”

In the past five years, the bird flu virus strain H5N1 has infected millions of poultry in Asia and Europe. There have been only 277 human infections and 167 deaths have been linked to outbreaks in 12 nations. Although no cases of a human infecting another human have been reported, epidemiologists say vaccines would be the best option to stop the virus if it mutates into a contagious human strain and leads to a pandemic.

The federal government has never approved a patch vaccine, but will likely use the same guidelines for approval as with other vaccine modes, say agency officials.

Iomai has already advanced three patch-based products to clinical trials and is working on an anthrax vaccine patch.

Market projections

Iomai projects a $1 billion annual market for its seasonal flu patch, which is entering phase 2, or mid-stage, clinical trials.

Also, the company’s booster patch for the elderly is in phase 2 trials. It is designed to boost immunity in seniors, who may have an immune response to vaccinations as much as 30 percent lower than younger patients. Placed over the skin point punctured by an injected vaccine, the patch stimulates response to the vaccine.

Sales of the booster patch could reach $300 million a year, the company says.

Iomai, which went public late last year, has grown from 66 employees in 2005 to 120. As of Dec. 31, the company reported $15.33 million in cash, with revenues of $1.48 million and a net loss of $30 million for 2006.

But Iomai faces competition from two other companies developing flu vaccine patches with funding from the National Institutes of Health, said David S. Cho, influenza product development program officer at NIH in Bethesda.

SRI International of Menlo Park, Calif., is developing a transdermal vaccine delivery research for influenza. Universal Stabilization Technology Inc. of San Diego received funding to develop alternative vaccine delivery routes similar to the skin patch.

At Iomai, Glenn, who is a pediatrician, is also excited about the company’s vaccine patch for an altogether different ailment: traveler’s diarrhea, which takes a devastating toll on children worldwide.

Iomai hopes to tap into a $450 million market with the treatment, which is scheduled for phase 3 trials early next year. The patch contains enterotoxigenic E. coli bacteria, which causes most cases of traveler’s diarrhea and causes sickness and death to millions of children in developing countries.

‘‘I would love to have our traveler’s vaccine, ETEC, get into the infants’ and children’s area,” Glenn said. ‘‘It would be very exciting. If you aren’t healthy, you can’t learn, and these types of insults can have a large impact on a child’s health and mentality.”

Iomai plans to sell its flu vaccine patches in packages that people can buy at a drugstore to vaccinate themselves.

The Iomai patch vaccine could be a new beginning in vaccines, said Dr. Neal A. Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health in Baltimore.

‘‘It will be wonderful if it works,” Halsey said. ‘‘They can be applied by people with not much training. And here in our clinics you could give more influenza vaccines. Right now, some people are throwing away vaccine, and other people can’t get it on time.

‘‘We could mobilize an army of people to give vaccines,” he said. ‘‘You would not have to create crowds of people, which creates more exposure.”

Medical patch industry

Medical patch treatments have been on the market since 1979 when the FDA approved a patch for motion sickness. Other patches treat nicotine addiction, chronic pain, estrogen replacement, bladder control, depression, osteoarthritis and other conditions. Besides Iomai, these Maryland companies are in the medical patch field:

BioElectronics Corp. of Frederick makes drug-free patches that deliver mild electromagnetic pulses to muscle swelling from wounds and surgeries.

Sequella Inc. of Rockville is developing a patch to diagnose active tuberculosis infections.

British firm Shire Pharmaceuticals, with a manufacturing facility in Owings Mills, is developing a one-a-day patch for attention deficit hyperactivity disorder in children 6 to 12 years old.