Market Opportunity

Hypogonadotropic Hypogonadism (HH) is an orphan indication, allowing for premium pricing, reduced development costs and consequently a greater return on investment. Current treatment options involve hormone replacement therapy, which is plagued with side effects, dependency and which induces infertility. For those patients wishing to remain fertile, add-on therapy with follicle stimulating hormones is required. In addition, administration of both hormone replacement therapy and follicle stimulating hormone is often difficult and expensive. There is therefore a real need for a drug that is safe, can be easily administered, that treats the full spectrum of the condition and that therefore does not require add-on treatment. NH901 meets this profile.

In addition to HH, age-related hypogonadism represents a rapidly growing billion-dollar market that is mostly treated with hormone replacement therapy. These are mostly elderly patients and hormone replacement therapy results in an increased risk of heart attack, stroke and even death in these patients. Data indicate that NHT’s treatment algorithm for leuprolide is effective in raising testosterone levels in a safe manner. NH901 is therefore anticipated to capture a significant market share and indication expansion to age-related hypogonadism is possible.