Changing Healthcare Worldwide

TESTAGEN TDS NEW DRUG APPLICATION FILED WITH FDA

Release issued 06/13/2013

PALM BEACH GARDENS, Fla. (June 13, 2013) --- On June 6th, Transdermal Delivery Solutions Corp. (TDSC), a company committed to developing innovative drug delivery technology and products, announced that their subsidiary had successfully submitted an investigational new drug application (INDA) to the U.S. Food and Drug Administration (FDA). The submission is for TDSC’s first product, Testagen™ TDS, a new and unique spray-on treatment for low testosterone levels in men, commonly referred to as Low T. The product is currently being prepared for clinical testing following the completion of a product overview, stability and scale-up reproduce-ability, pre-clinical and clinical findings and proposed protocols. The company anticipates beginning clinical trials in July of this year.

 Approximately 13.8 million men in the United States suffer from low testosterone levels, which have been linked to common ailments ranging from hypertension to low sex drive. Testosterone Replacement Therapy (TRT) drug sales have increased dramatically over the past six years, from approximately $552 million in 2006 to over $2.1 billion in 2012.

 Testagen™ TDS® is a patented treatment formulation technology that is expected to revolutionize topical testosterone application because it enables rapid, nearly complete absorption of controlled amounts of testosterone across intact skin. The system is based on a delivery vehicle which mimics the physical chemistry of compounds that readily transmigrate the skin and provides faster absorption, lower concentrations left on the skin, and lower cost than current transdermal formulations. The formulation process produces an extremely stable dose-specific and drug-specific formula enabling rapid, safe and efficient transdermal drug delivery.

 Testagen™ TDS® was developed through a proprietary system that measures and calculates the intermolecular attractive and repulsive forces of the drug. The patent features include the conceptual development and process for designing and formulating a unique, balanced transdermal system for a particular drug, in this case Testosterone. Because the resulting product is liquid, dosing can be adjusted for individual needs by modifying the number of sprays applied. The rapidly drying ethanol base is expected to greatly diminish or eliminate any danger of transferring testosterone to women or children, a significant health risk from existing gel therapies. It is expected that Testogen™ TDS will stand alone as the only product to meaningfully address the health risk of transference with a more convenient, flexible-dosing, easy-to-apply product.