Following the publication of my article on the blockbuster potential of Antares Pharma Inc (NASDAQ:ATRS)‘s transformational product (Otrexup), I have been inundated with reader requests to conduct a valuation study on another drug-device combination currently being advanced into clinic by Antares, i.e., Vibex QS-T, which is targeting the testosterone replacement therapy (TRT) market.
QS-T is being developed to administer testosterone using a subcutaneous (SC) injection route by patients themselves, essentially eliminating the need to receive intra-muscular (IM) injections at the doctor’s office. So far QS-T has received negligible attention, mainly because its expected launch date is 2016. This article intends to fill that gap by presenting how much peak sales QS-T is expected to generate as I review the demand drivers, competitive landscape, testosterone market size, and how Antares Pharma Inc (NASDAQ:ATRS)’s QS-T differs from the existing treatment options, which are given next.
Gels are the most expensive treatment option for TRT with the following disadvantages compared to QS-T: (1) The amount of testosterone that is absorbed into the bloodstream varies widely from patient to patient, (2) gels have a propensity to rub off on other people, e.g., from a father to a child, which caused FDA to require “black box” warnings be added to the labels for AndroGel, which is manufactured by Abbott Laboratories (NYSE:ABT) and Testim gel, which is manufactured by , (3) application of testosterone on human skin causes some of the testosterone to be converted into DHT (another male hormone), which results in many side effects such as hair loss, acne, prostate enlargement, elevated PSA levels, and cancer, and (4) gels cause skin irritation, redness, itching, and burning.
Abbott and Auxilium (NASDAQ:AUXL) put boldfaced warnings on all their packaging and marketing material, and they had to produce new package inserts instructing patients to wash their hands thoroughly after applying their gels. I see Antares capturing significant market share from Abbott and Auxilium gels, as QS-T will directly address the variable and insufficient absorption problem.
Due to the limited ability of skin to absorb testosterone, patches contain permeation enhancers, which cause one third of the users to suffer from skin irritation. Remaining disadvantages of patches are the same as those that I discussed for gels.
Oral testosterone has been used in Europe for decades but was never approved in the US mainly due to concerns about liver safety. Oral forms of testosterone have been associated with drug induced liver damage.
Pellets, each containing crystalline testosterone, are implanted subcutaneously to provide slow release over six months. Compared to QS-T, implantable testosterone have the following disadvantages: (1) They require a surgery to be implanted, (2) pellet extrusion is seen in 12% of the patients, (3) some patients suffer from bleeding and infection, and (4) most insurance carriers do not cover pellets.