Testogen™ TDS® -enhanced testosterone is an investigational transdermal
formulation containing TTI's patented, TDS® system formulated for testosterone.

How does it work?
TTI has demonstrated in both pre-clinical and clinical testing that TDS® enables
the absorption of testosterone through human skin rapidly, safely and effectively
and is bio-equivalent to hydro-alcohol gel systems currently on the market.
Clinical observations have demonstrated that Testogen TDS® is well tolerated,
accomplishes increased blood levels and maintains them over a twelve-hour span.

How is it different?
Because testosterone is rapidly metabolized in the liver when taken by mouth (and may
raise blood lipid levels), the preferred methods of delivering testosterone are through-
the-skin treatments, mostly depo injections. The pharmaceutical industry's prior
attempts to produce topical hormone replacement therapies, however, have been
frustrated by incidence of local irritation, difficulties associated with applying the
required dosages to an esthetically acceptable skin area and achieving therapeutic
blood levels. The enhanced absorption of testosterone afforded by a topical TDS®
testosterone drug will allow for an application area much smaller than that for the
currently marketed products. Patients and clinicians have reported high satisfaction
with, and a preference for Testogen’s rapidly absorbed lotion.

Male Hypogonadism
Male hypogonadism refers to inadequate gonadal function that may be manifested as
decreased concentrations of free testosterone in the blood. The average male normally
produces about 7-10 mg of testosterone daily. Output below this level may cause only
modest changes initially, such as an increase in weight, progressive aging of the face
or muscular weakening. Prolonged, profound hypogonadism sufferers may experience
failing memory, irritability, general fatigue, the development of arteriosclerosis,
varicose veins, hemorrhoids, atrophy of the skin, hypertension and increased
cholesterol, diminished libido, erectile dysfunction, infertility, gynecomastia
(breast enlargement), changes in body composition (increased fat/muscle ratio),
reductions in body and facial hair and osteoporosis. Beyond trauma and certain
uncommon diseases, research suggests that most hypogonadism appears to be
age-associated. The clinical challenge of treating hypogonadism is determining
when to initiate pharmacologic therapy. Many men experience seriously diminished
testosterone levels without troubling signs or symptoms, while others seek
treatment when their hormone levels are less significantly depressed.

Enhanced Penetration of Testosterone Through the Skin
Pre-clinical testing in the laboratories of TTI’s research partners, The Department of
Experimental Pathology at St. Bartholomew’s and the Royal London School of Medicine,
has demonstrated that TDS® significantly enhances the absorption of testosterone
through skin when compared with either testosterone patches or gel formulation. A
clinical trial, approved under the British Medicines Control Agency’s stringent
safety criteria, compared Testogen TDS® to the most-prescribed gel formulation
looking both at kinetics and residual drug latency on the skin. The study, published in the British Journal of Clinical Pharmacology (March, 2006) concluded that Testogen TDS® achieves therapeutic blood levels of testosterone in less than 30 minutes from application
with a smaller volume dose than gels, maintaining the normal range for more than twelve hours after dosing and is bio-equivalen to the approved AndroGel(R) product. The current market for all testosterone products sold in the United States is about $600 million. It is estimated that approximately 13 million men in the United States are testosterone deficient, but less than 3 million currently receive testosterone replacement therapy. The low rate of diagnosis, combined with increasing attention to the risks of undiagnosed hypogonadism, is likely to significantly increase the size of this market in the future.