Changing Healthcare Worldwide


Release issued 06/15/2007


The U.S. Patent and Trademark Office has notified TransDermal Technologies, Inc. of the allowance of claims under U.S. Patent application 20060121103. This patent is a product-by-process patent describing the application of the company's TDS® liquid sprayed-on drug delivery technology to pharmaceutical, cosmetic and nutritional actives.

"We are obviously very pleased with this development as it sets a clear path forward for patenting each application of a compound with TDS for delivery across intact skin without patches or other devices," company President and co-inventor Kenneth B. Kirby stated.

"The pace of industry and university interest in the TDS technology has been picking up this year on the heels of several peer-reviewed journal publications of our clinical success and this new patent which further strengthens our IP position. We feel that a clear way forward for patentprotecting a therapeutic indication coupled with the technology's ease and speed of formulation development should only encourage groups to opt in sooner," Kirby continued. "We have a number of development projects underway at present and are having discussions with several more groups about additional applications and expect that interest will be further spurred by results of a recently completed successful trial for delivery of a CNS drug," said Kirby.

The TDS is composed of a particular active agent which dictates an associated selection of certain solvents, solvent modifiers, solute modifiers and skin stabilizers with which the medicament forms a true solution that rapidly crosses the skin barrier. The associated selection is based on a balancing of the molecular properties of all the components against the molecular properties of all the components plus the particular active agent.The TDS can include solvent complex modifiers for regulating the rate of absorption of the active agent. The TDS may also include a source of cellular energy to induce CAMP or cGMP. The TDS improves delivery of active agents having a molecularweight greater than 340 Daltons and increases dosage above 0.25 mg/day for such active agents.

The system has successfully delivered doses as high as 500 milligrams per dose and up to smallpeptides up to about 2,000 Daltons in size in pre-clinical and clinical trials. Drugs have beenshown in clinical trials to be bio-avalable and bio-active in as little as 5 minutes. TDS formulationshave been universally well-tolerated in over 1,000 clinical trial exposures. The costs of the system iscompetitive with tablet dose forms.

The company is actively seeking partnering opportunities with pharmaceutical and consumer care products companies and has two compounds through phase II trials which are available for license.

For more information contact:

Kenneth B. Kirby