Male hypogonadism, goes by many names ("Low T", "Andropause" and "Male Menopause") and refers to age-related reduction of circulating endogenous testosterone. On average, a 50-year-old male will produce approximately half the testosterone they once had at age 25. Symptoms of Low T include diminished libido, fatigue and irritability. Low T is often misdiagnosed as a host of other maladies, including depression and erectile dysfunction. It is conservatively estimated that Low T affects 13 million American men, up to 90% of whom go untreated. Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations.
For the 12 months ending December 2012, the total United States hypogonadism market reported sales in excess of $2.1 billion having grown 30% over the previous 12 month period. The current United States competitive landscape for testosterone preparations offers topical products, in both gel and patch presentations, short-acting injectables as well as a buccal patch. In terms of market share, topical gels represent approximately 90% of the total sales volume; the short-acting injectables and topical patch products each represent approximately 5% of the sales volume.
CompleoTRT™ (formerly TBS-1)
The Corporation’s most advanced product candidate, CompleoTRT™, is a bioadhesive intranasal gel formulation of testosterone. CompleoTRT™ is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.
On July 9, 2013, the Company announced that the CompleoTRT™ New Drug Application ("NDA") was formally accepted by the United States Food and Drug Administration ("FDA"), which was filed on April 29, 2013. The FDA has confirmed that under the United State Prescription Drug User Fee Act, the NDA will be subject to a standard review and the target action date for the NDA is February 28, 2014.
Subject to the approval of the FDA, CompleoTRT™ is designed to be applied to the interior lateral wall of the nasal cavity, where studies have demonstrated that the gel is fully absorbed into the nasal mucosa within 15-30 minutes. There is virtually no smell or taste associated with the gel. It is expected that, as a result of the “no touch” targeted delivery to the nasal mucosa, CompleoTRT™ should avoid skin-to-skin transference to third parties, a health risk that led the FDA to issue a “black-box” warning in May 2009 for secondary transference for all topical testosterone gel preparations.
To date, the FDA has not asked the Corporation to conduct any patient transference studies, supporting the Corporation’s expectation that the CompleoTRT™ label will not contain a “black box” warning. When comparing CompleoTRT™ versus currently marketed topical testosterone gel preparations, the Corporation believes that in addition to the avoidance of skin transference issues, enhanced patient compliance may be derived from the ease of application, the lack of any mess or odour from the gel, as well as the convenient dosing via the novel multi-dose nasal dispenser.
CompleoTRT™ has concluded a comprehensive clinical development program, announcing top line Phase III efficacy results in December 2012. The CompleoTRT™ Phase III clinical trial results demonstrated that after ninety (90) days of product dosing, average serum testosterone levels for patients involved in the study were within FDA efficacy guidance for a testosterone replacement therapy. The Corporation’s and external expert analysis of the Phase III clinical trial efficacy data is based on results from 306 patients who participated in the study.
In March 2013, the Corporation announced that it has received positive secondary efficacy endpoint and safety results from the CompleoTRT™ pivotal Phase III clinical study. These results complement the previously announced Phase III pivotal clinical trial results indicating that CompleoTRT™ met its primary efficacy endpoints. The pivotal study protocol included evaluations of the impact of treatment with CompleoTRT™ on body composition (total body mass, lean body mass, fat mass, percent body fat), bone mineral density, mood and erectile function. Following ninety (90) days of CompleoTRT™ treatment, a statistically significant improvement over baseline was observed in all domains related to erectile function and mood. As well, CompleoTRT™ treatment demonstrated favourable trends with respect to its effect on bone mineral density and improvements in body composition parameters.
The safety study results demonstrated that after 360 days of treatment, the CompleoTRT™ safety profile was consistent with currently marketed topical testosterone replacement therapies. There were no drug related serious adverse events observed at any safety time point during the study, and there was a decrease in mild and moderate drug related adverse events over time. Measures of nasal tolerability demonstrated that CompleoTRT™ was well tolerated in the nasal mucosa, with no adverse event trends.