Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, announced that new data from the two-part HYHYHI Study (Hypogonadal Hypotestosteronism in HIV-Seropositive Men) were presented as a poster today at the 5th International AIDS Society (IAS) Conference in Cape Town, South Africa. This retrospective chart review, supported by the Company, evaluated the challenges associated with diagnosing low testosterone in men with HIV/AIDS. The study also compared the difference in testosterone levels achieved after 12 months of treatment with either Testim® 1% (testosterone gel) or AndroGel®, two commonly used FDA-approved testosterone replacement products.

Results from the study showed that when using the more sensitive Free Testosterone test (FT < 50pg/ml) as a measurement, approximately 64 percent of the 396 men in the study were diagnosed with Low Testosterone (Low T), whereas only 35 percent of these men in the study would have been diagnosed with Low T when the more commonly used Total Testosterone (TT < 300ng/ml) was used. Dr. Gary Blick, M.D., A.A.H.I.V.S., medical and research director of CIRCLE Medical, stated that men with HIV/AIDS often have lower levels of Free T due to an increase in the protein SHBG (sex hormone-binding globulin), which can restrict the amount of testosterone available for the body to use.

Patients using Testim for at least six months achieved median Total T levels of 682 ng/dL (80% increase from baseline) and Free T levels of 102 pg/mL (69% increase from baseline). Those using AndroGel over a similar time period achieved Total T levels of 450 ng/dL (17% increase from baseline) and Free T levels of 87 pg/mL (47% increase from baseline). The study also showed that 5.3 percent of patients using Testim switched to another treatment, versus 15.2 percent of those using AndroGel. Additionally, 2.7 percent of patients using Testim titrated to a higher dose, versus 24.1 percent of those using AndroGel.

"The incidence of low testosterone in men with HIV/AIDS may be even higher than previously estimated," said Dr. Blick. "Results from this study suggest the use of free testosterone may provide a more sensitive method of diagnosing Low T in men living with HIV/AIDS and allow them to begin treatment with a testosterone replacement therapy, such as Testim, in order to restore normal testosterone levels."

About the Study

The HYHYHI study, designed and conducted by Dr. Blick, was a retrospective chart review of men with HIV/AIDS screened for Low T and treated with testosterone replacement therapy. Data were collected from two U.S. sites and included 400 men diagnosed with HIV/AIDS and screened for Low T, defined as Total T < 300 ng/dL and/or Free T < 50 pg/mL. Free testosterone is the unbound form of the androgen that can actively interact with cells. Total testosterone measures both free testosterone and testosterone (T) that is bound to plasma proteins. Patients using AndroGel (n=92) or Testim (n=75) for at least 6 months were randomly selected for this study. Their charts were reviewed for testosterone levels, lipid measurements and PSA determinations, as well as symptomatic improvements. The most common presenting symptoms of Low T in the study included fatigue, decreased focus/concentration, depression, decreased libido, decreased peripheral muscle, increased abdominal girth, and erectile dysfunction.

Previous estimates suggest that between 30 and 50 percent of men with HIV/AIDS are estimated to have low testosterone levels due to their body's inability to produce sufficient quantities of testosterone. Testosterone is one of the most important circulating hormones in men, affecting the brain, muscle, kidneys, bone marrow, bones, liver and skin. "Low T can cause a multitude of significant symptoms, including depression, marked fatigue, poor focus and concentration, decreased late day energy and endurance, loss of muscle mass, increased abdominal fat and bone loss, in addition to erectile dysfunction and decreased sexual libido," continued Dr. Blick. "Recognition of these symptoms and proper diagnostic testing will allow patients to be initiated on appropriate treatment."

About Testim

Testim is a proprietary, clear, topical gel containing 1% testosterone, the same type of hormone that is produced by the human body. When applied once-daily to the upper arms and shoulders, clinical studies have shown that Testim will restore and maintain testosterone levels. Once Testim is absorbed through the skin, it enters the bloodstream and helps return testosterone to normal levels. The efficacy of Testim has been demonstrated in 16 clinical studies involving approximately 1,800 patients, including the largest placebo-controlled study ever conducted to evaluate the benefits and risks of testosterone replacement therapy. Auxilium estimates that approximately 76 million tubes, or daily applications, of Testim have been used since the product was launched in 2003. For information regarding the safety and use of Testim, please see the prescribing information at http://www.testim.com.

Source
Auxilium Pharmaceuticals, Inc.