Out-licensing

Towards the Clinical Development of Bio-T Gel: A Once Daily Transdermal Gel to Treat Male Hypogonadism

Introduction/Background

Since testosterone is largely rendered inactive in the liver, oral administration, which results in rapid absorption into the portal blood, is not feasible since it does not allow clinical testosterone levels to reach systemic circulation. Injected testosterone is also rapidly absorbed and degraded, making maintenance of physiological levels in plasma difficult. Injections of testosterone are also associated with increased serum lipid levels and require large needles for often painful intramuscular delivery. Therefore, transdermal delivery approaches have been developed to promote therapeutic effects in a more patient-friendly manner. Dermal patches have been used successfully for the delivery of testosterone but have been associated with skin irritation. For cosmetic reasons, smaller patches are preferred, but as the surface area of the patch decreases the concentration of testosterone and the alcohol solvent it is dissolved in necessarily increases. Constant exposure of the skin to such high concentrations of this testosterone-alcohol mixture leads to irritation.

BioSante is focused on building a robust portfolio of products for the treatment of human hormone deficiencies, including hypogonadism. Symptoms of hormone deficiency in men may include impotence, lack of sex drive, muscle weakness and osteoporosis. Since testosterone is largely rendered inactive in the liver, oral administration that results in rapid absorption into the portal blood is not feasible since it does not allow clinical testosterone levels to reach systemic circulation. Injected testosterone is also rapidly absorbed and degraded, making maintenance of physiological levels in plasma difficult. Injections of testosterone are also associated with increased serum lipid levels and require large needles for often painful intramuscular delivery.

Aims/Hypothesis

Bio-T Gel (male testosterone gel) is being developed as a once daily transdermal gel for treatment of hypogonadism (low testosterone levels) in men. The symptoms of hypogonadism include impotence, lack of sex drive, muscle weakness and osteoporosis.

Research

Biosante's research has centred on developing a novel formulation for improved testosterone administration. BioSante has begun human clinical trials on their novel gel formulation in order to obtain Food and Drug Administration (FDA) approval to market as soon as possible. The gel is designed to be quickly absorbed through the skin after application on the arms, shoulders, abdomen or thighs, delivering the required hormone to the bloodstream evenly and in a non-invasive, painless manner.

Conclusion

BioSante has developed a testosterone gel formulation, Bio-T-Gel, which can be applied topically on the skin where it dries rapidly, thus avoiding irritation problems commonly seen with dermal patches. Additionally, cosmetic issues should not be a concern since the gel is clear and dries almost immediately after it is applied; therefore, the gel is less conspicuous than a patch.

Relevance/Opportunity

Bio-T Gel is a transdermal testosterone gel for the treatment of hypogonadism in men. Worldwide licensing is available, other than US and Canada. Please enquire below if you are interested in this opportunity.

Phase I