Bolstered by soaring demand for testosterone replacement products, a deal with GlaxoSmithKline to market its top drug Testim, and now favorable results of a new drug study to treat penile curvature, things are looking up for Auxilium Pharmaceuticals.
Reuters reports that shares of Auxilium, a small drug company based in Malvern, Pennsylvania, shot up 17 percent Monday on news that two late-stage trials indicated its drug Xiaflex reduced curvature of the penis by more than 30 percent in men with Peyronie’s Disease, a condition caused when excessive collagen protein deposits create curvature and sometimes painful erections.
Xiaflex is already approved for use as a treatment for Dupuytren’s Contracture, a condition marked by tightening of the hand muscles. In addition to Peyronie’s Disease trials, the drug is being tested for adhesive capsulitis or frozen shoulder syndrome. Collagen accumulations are the common denominator in all three conditions.
Auxilium has an agreement with pharmaceutical giant Pfizer Inc., which makes Viagra, to market Xiaflex for the hand tightening condition in Europe. According to Reuters, Auxilium’s chief executive expects that Pfizer will promote the drug for penile curvature as well. The company expects the drug to win U.S. Food and Drug Administration (FDA) approval for that condition by the end of the year.
U.S. sales of the drug will likely top $100 million annually, one market analyst told Reuters.
Last month, the Auxilium entered a similar partnership with GlaxoSmithKline to promote and sell its testosterone-replacement gel Testim on a larger scale. Testim, a topical gel containing one percent of the hormone, is normally prescribed to men who are testosterone deficient, but there is a growing demand for it and similar drugs among men who don’t need it but want it for recreational and sexual enhancement purposes.
Rocketing sales of Testim and other testosterone replacement therapies such as Androgel, made by Abbot Laboratories in 1% and 1.62% solutions, have raised concern about the risk of secondary exposure to the topical drugs in women and children. Because the drugs are usually applied to the upper arm or shoulder, women and children may be exposed to them through contact with the user or his clothing, towels, and bed sheets.
Women and children who come into contact with a Testim or Androgel user or his clothing, towels, and bed sheets, may develop adverse effects as a result of increased testosterone. Women exposed to testosterone gel products may experience outbreaks of acne or changes in hair distribution; in children, signs of premature puberty are possible, as well as aggressive behavior and advanced bone age.