Release issued 5th March 2004

LAKE PARK, FLORIDA - TransDermal Technologies, Inc. announced today the successful completion of the first phase of its next clinical trial to validate its patented, patchless liquid transdermal delivery system, TDS® in the delivery of Testosterone. This second clinical study of the company's liquid transdermal delivery system TDS® in humans, was approved by North East London Ethics Committee and received DDX certification from The European Medicines & Healthcare Regulatory Authority in September 2003.

The study is being completed by Dr. Chandan A.S. Alam, M.D. and Dr Arthur T. Tucker, PhD of the William Harvey Institute at St. Bartholomew's and the Royal London School of Medicine and Dentistry. The Langford Institute sponsors the study. The trial will measure the ability of the TDS® technology to deliver testosterone through the skin without a patch or other appliance over an eight-hour window, as a topically applied hormone replacement.

The just-completed first phase of this trial was a simple dose response trial of 5 single doses of Testosterone ranging from 10 to 50 milligrams delivered one each to 5 healthy volunteers. The results were supportive of progressing the trial to its next stage - a phase Ib comparison of the TDS® system against a commercially available hydro alcohol gel system approved in the U.S. for testosterone hormone replacement therapy. In addition to comparatively evaluating the pharmacokinetics of the two systems it will seek to examine safety by measuring residual hormone that remains on the skin. Gel systems commercially available in the U.S. must carry a safety warning to reinforce the dangers of reducing the total dose by washing off the drug which remains on the skin for up to 5 hours and the danger, during this latency of delivering a potentially harmful dose inadvertently by physical contact. TDS® is designed to rapidly and completely deliver the target drug or hormone within a few minutes of application. The study is designed to demonstrate the enhanced safety and efficacy of the TDS® over hydro alcohol gels.

This second trial comes on the successful completion of the company's first human trial last year that was completed in June. This trial tested the effectiveness of the TDS® in the delivery of Lidocaine as a venipuncture anesthesia intervention in 100 subjects.

Testosterone hormone replacement therapy is on the rise in both men and women due to recent studies establishing its safety in the treatment of Virapause and Menopause. Both injection, patch delivery and gel systems leave room for improvement, either in the necessity for regular injections, size of dose deliverable with patches or activity restrictions, which are imposed as safety precautions due to significant amounts of hormone remaining on the skin over hours with gels. These compliance challenges notwithstanding, sales of testosterone HRT products are growing incrementally and exceed $300 Million a year, with the advent of needle-less delivery. "A sprayed on, rapidly absorbed, convenient TDS® testosterone system incorporating incremental improvements, when proven safe and effective, should be rapidly approved for use and readily accepted by this growing market." Kirby said.

Transdermal drug delivery via the TDS® offers significant advantages. By bypassing the gut and first-pass liver metabolism, liver stress is eliminated or minimized. Also the TDS® can be modified to deliver a concentrated dose of drug 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 dosing. TransDermal Technologies is actively seeking a licensing partner or partners interested in exploiting this technology for testosterone.

The TDS® is a platform system that is modified to be specific to each application and has been proven to accomplish 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

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