Changing Healthcare Worldwide

TDS® METHOD PATENT IS PUBLISHED

Release issued 09/10/2004

Lake Park, Florida - TransDermal Technologies, Inc. announced today the issuance of U.S. Patent 6,787,152, Compositions for Rapid and Non-Irritating Transdermal Delivery of Pharmaceutically Active Agents and Methods for Formulation, from the U.S. Patent Office. The claims in this method patent define the second invention describing the company's liquid transdermal delivery system, TDS®. The patent carries a priority date of May, 2000 and an issue date of September 9th, 2004 and is a division application from U.S. Patent 6,444,234. The TDS® patent case has been divided into four inventions, two of which are now patented and the claims defining the additional two inventions will be prosecuted immediately.

This announcement comes on the heels of several positive outcomes obtained by TransDermal in pre-clinical and clinical kinetics and therapeutic outcome trials designed to prove the technology's safety and broad applicability. These trials have been overseen by Dr. Chandan A.S. Alam, of the Department of Experimental Pathology and Dr. Arthur Tucker of the William Harvey Institute at the Royal London School of Medicine and Dentistry. Data has now been logged on 11 different molecules in 15 different trials of diverse, and in some cases, difficult-to-deliver compounds delivered through intact skin by means of the TDS® technology without a patch, gel or other appliance. Several other pre-clinical and clinical trials of TDS® applications are under way at St. Bartholomew's.

Data from the various studies confirms company patent claims that the TDS® technology enables rapid, safe penetration and bio-availability of therapeutic blood levels of the drugs trialed and significantly, these levels are obtained more rapidly than from any other non-injecton transdermal delivery devices(TDD) in some cases as quickly as within 5 minutes and maintaining therapeutic levels over 8 hours. Over 400 patient exposures have yielded no adverse reactions or skin irritations. The establishment of the claims for the TDS® technology along with the growing log of data mark a major step forward in fulfilling the promise of needle-less transdermal delivery heralded more than 20 years ago by Alejandro Zaffaroni and Alec Keith. Patches, gels and other alternative routes such as inhalation, nasal, trans-buccal and needle-less compressed air injection through the skin held promise for rapid, safe and effective drug delivery that bypasses the liver and gut. Unfortunately, with a few notable exceptions, these modalities have encountered limitations either of drug applicability (molecular size, dose amount), cost per dose or patient acceptance which have greatly reduced their expectations. TDS® stands alone in its ability to deliver large doses of large and small molecule drugs and peptides rapidly and safely across intact skin, in a simple, safe easy- to-use, low cost format.

TDS® has demonstrated that it enables formulation of delivery systems particular to the drug being delivered. Rather than a "one-size-fits-all" approach, TDS® designs a unique formula employing chemically diverse solvents enabling delivery of drug and peptide categories across the spectrum. The system also employs routines which enable greatly increased solvation of actives into smaller volumes which readily transmigrate the skin without any downside impacting patient compliance or limiting its applicability due to dose size. No other delivery system has demonstrated TDS®'s ability to dissolve and successfully deliver transdermally highly lipophilic drugs and peptides or drugs which have molecular weights greater than 350 Daltons in doses larger than 40 mg. which are otherwise resisted by the skin.

TransDermal Technologies is actively seeking additional licensing partners interested in exploiting the TDS® technology. The TDS® is a platform system that is designed to be modified for each application and is believed to enable the rapid, safe and effective delivery of many medicaments across intact skin by means of its sprayed on or applicator applied lotions.

Company Contact: Kenneth B. Kirby - K.Kirby@Transdermaltechnologies.com / 800-282-5511 /561- 848-9100