An early-stage medical device company focused on the multi-billion dollar market for skin patches that release prescription drugs into the body hopes to license its first product by the end of the year.
Transdermal patches have been used for decades to wean patients off nicotine and administer hormones. But Warwick-based Isis Biopolymer Inc. is developing more-active patches, with paper-thin, flexible electronics built into them that enable doctors to set the amount of medication the patches administer to each patient.
Doctors would e-mail individual prescriptions for each skin patch to a pharmacy, where the prescription would be programmed into the patches using a hand-held electronic device. Once programmed, the patches could be worn for up to a week before being replaced.
“Because it’s a software-driven product, we can effectively turn on and turn off the dose profile any way that we want over a 24-hour period and over a seven-day period,” said Michael Jordan, Isis Biopolymer’s director of product development. “It really allows a doctor for the first time to prescribe a medication [through a skin patch] and be able to dose it any way that they see fit.”
Emma A. Durand, Isis’ president, founded the company last August with a plan to transfer to the medical device field science she mastered while serving as the chief technology officer for American Biophysics Corp., the former North Kingstown-based manufacturer of the Mosquito Magnet, which by 2003 had become one of the fastest growing private firms in the nation.
In a wild reversal of fortune, American Biophysics was bankrupt by 2006, setting the stage for a sale of the company to a Pennsylvania-based firm last April.
Among the handful of people Durand recruited to start Isis Biopolymer was Jordan, who had worked for Durand at Poly-Flex Circuit Inc., a manufacturer of flexible circuits that Durand founded and subsequently sold before moving on to American Biophysics.
Isis Biopolymer is not the first medical device company to develop an active transdermal patch capable of metering individual doses of medication. But the company’s patch, which resembles a Band-Aid, is much thinner and more comfortable than similar products already developed, Jordan said.
“There are similar products on the market, but they’re rigid and plastic,” he said. “It’s like trying to wear an iPod on your body instead of a Band-Aid-thin substrate.”
This is how the skin patch works: A flexible, razor-thin circuit board built into one side of the patch creates a low-level electric charge that forces out medicine molecules loaded as an ionized hydrogel into miniscule chambers in the patch’s adhesive.
Because the drugs are absorbed through the skin directly into the bloodstream, skin patches are seen as having some important advantages over pills. Most significantly, they can eliminate the upset stomach that medicines ingested into the stomach can cause some patients. Patients also don’t have to remember to take their medicine throughout the day.
Ninety-eight percent of all prescription drugs can be put into liquid form and administered via such a transdermal patch, representing multi-billion dollar potential on the world market, Jordan said.
Isis Biopolymer has finished development of the patch and its related software, and will bring the product into clinical trials this summer to test its delivery of medications to treat diabetes, attention deficit hyperactive disorder and movement disorders like Tourette syndrome and tardive dyskinesia.
“We have a patch right now that is functioning and we have software that is operational,” Jordan said. “Right now, we’re just fine-tuning the system itself.”
The company recently entered into a manufacturing agreement with Demmel Group, a company in Germany, which will manufacture some of the patches. Different patches designed to administer more than one drug at once will be manufactured at Isis’ plant in Warwick.
Isis Biopolymer hopes to license the product to a major pharmaceutical company by the end of the year, Jordan said. The plan is for the pharmaceutical company to help secure FDA approval of the new technology in 2009, and then market and distribute the product.
Isis Biopolymer completed a first round of funding last year, and is currently in a second round of funding aimed at raising $2 million – enough to pay for the clinical trials, buy new equipment, and double its work force within the next year, Jordan said. The company currently employs 10 people at its Warwick facility.
Last month, the company was pre-approved to receive a $100,000 tax break from Rhode Island through the state’s new Innovation Tax Credit. Businesses approved for the program, which was created late last year, can offer investors and others a credit of up to $100,000 off their individual state income-tax bill in return for their commitment. •
