Changing Healthcare Worldwide

TDS® PATENTS PUBLISHED

Release issued 09/05/2002

Lake Park, Florida - TransDermal Technologies, Inc. announced today the publication of patent claims for the company's liquid transdermal delivery system, TDS®. The patent, U.S. 6,444,234, carries a priority date of July, 1998. The company's patent case has been divided into five inventions and these subsequent 44 claims are currently awaiting office action.

This announcement comes on the heels of several positive outcomes obtained by TransDermal in pre-clinical and therapeutic outcome trials which have been overseen by Prof. Derek Willoughby and completed by Dr. Chandan A.S. Alam, of the Department of Experimental Pathology of the Royal London School of Medicine and Dentistry. Pre- clinical data has now been logged on Cystamine, Testosterone, Morphine, Acyclovir, Hydroxyzine and Ibuprofen and therapeutic outcome data on Ibuprofen delivered through intact skin by means of the TDS® technology without a patch or other appliance. Several other pre-clinical trials are under way at St. Bartholomew's. Human trials on two molecules are pending. Data from the various studies confirms company patent claims that the TDS® technology enables rapid penetration and bio- availability of therapeutic blood levels of the drugs trialed and significantly, that these levels are obtained more rapidly than from any other transdermal delivery device (TDD) and that the TDS® system can be modulated to accomplish different absorption curves.

The establishment of these claims marks a major step forward in fulfilling the promise of needle less transdermal delivery heralded more than 20 years ago. Patches and other alternative routes such as inhalation and micronized powder injection 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) or patient acceptance which have greatly reduced their expectations. TDS® appears to accomplish its therapeutic goals of enabling formulation of delivery systems particular to the drug being delivered. Rather than a "one-size-fits-all" approach, TDS® can employ chemically diverse solvents embracing drug categories across the spectrum. The system also employs routines which enable greatly increased solvation of actives into smaller volumes which readily transmigrate the skin apparently without any negative downside impacting patient compliance. No other delivery system has demonstrated TDS®'s ability to solve and successfully deliver transdermally highly lipophilic drugs or drugs which have molecular weights greater than 350 Daltons in doses larger than 20 mg. which are otherwise resisted by the skin.

The need for alternative dosing capability as provided by transdermal means is particularly felt in the case of analgesics and narcotic pain relievers. Many patients poorly tolerate NSAIDs or non-steroidal anti-inflammatory drugs including ibuprofen due to gastro-intestinal distress and liver metabolism issues. Patients must be particularly careful about consuming alcohol with many of these drugs due to interactions between them. Narcotics, while highly effective pain relievers are also very dosesensitive with potentially lethal side effects for over-dose. The TDS® may be able to effectively mitigate all of these issues with both NSAIDs and narcotics. The TDS should accomplish the therapeutic outcome that the drug is designed for with much smaller doses than oral equivalents as demonstrated in the company's successful pre-clinical studies. By bypassing the gut and first-pass circulation from the gut to the liver, GI distress and liver metabolites are eliminated or minimized. The TDS can be modified to deliver a concentrated dose to a local area, which is not broadly distributed throughout the body. This capability, coupled with the smaller doses possible with the TDS® enables much safer narcotic dosing that virtually eliminates the possibility of overdose and greatly reduces tolerance- building that leads to addiction.

TransDermal Technologies is actively seeking a licensing partner or 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: Elizabeth Handel, Ph.D. - Libbyhandel@adelphia.net / 800-282-5511 / 561-741-4284