Hypogonadism, the absence or deficiency of male gonad function that results in insufficient testosterone secretion, affects four to five million American men.
Studies show age-related increases in prevalence and associations with other diseases and conditions, such as diabetes and obesity, meaning that the trend points towards more diagnoses in the future, as the disease has no cure.
In Canada and the U.S., men can look to Natesto, a replacement therapy of Toronto-based Acerus Pharmaceuticals Corp. (TSX:ASP) for some relief.
Thanks to a "no-touch" dispenser with a metered dose pump, Natesto is the only testosterone replacement therapy (HRT) without a Black Box warning related to transference of testosterone. Testosterone transference is a genuine concern in the HRT space, as even small amounts transferred to children, pets and even spouses can have a profound consequences.
Moreover, in Canada, the recommended dose of Natesto, a nasal gel, happens to be the lowest dose of any topical gel testosterone in the country.
Today, Acerus said it received $1.6 million in orders for Natesto from Aytu Biosciences (NASDAQ:AYTU), the U.S. licensee of the product.
The order is expected to fill Aytu's needs for the rest of the year and early part of 2018. Acerus gets to book the order revenue this quarter and any royalty payments when they arrive on a quarterly basis.
Natesto used to be sold in the U.S. through a deal between Canadian Endo Pharmaceuticals (NASDAQ:ENDO) and Acerus (called Trimel Pharmaceutical at that time), a deal that Endo pulled out of last year. The new orders are the first to bear the Aytu brand now that the products with the Endo moniker have been depleted, which is expected to help build market awareness for Aytu.
Aytu CEO Josh Disbrow said in a statement today that he expects adoption of Natesto to continue to grow, a forecast underscored by increasing prescription sales and number of script writers.
Moreover, while sales move forward in North America, marketing approval is pending in South Korea, with plans to add other jurisdictions in the future, according to Acerus.
Investors have been buying-up shares of ASP lately, driving the stock price from a November low of 11.5 cents to as high at 52 cents on Monday. After a quick pullback to 30 cents, shares are back on the climb today, printing 38 cents for a gain of 23% as of 1:40 p.m. EST.