Solvay Pharmaceuticals, Inc. announced today that a new analysis of pivotal study data conducted by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center showed that initial treatment response of hypogonadal men with AndroGel® (testosterone gel) 1% CIII had similar effects on subjects, regardless of weight and body mass index (BMI). These study results were presented at the 2008 Endocrine Society Annual Meeting (ENDO) in San Francisco.

“Multiple studies have shown that obese men are at an increased risk of having low testosterone levels, so these new findings provide important insight into optimal treatment regimens for hypogonadal men,” said Dr. Christina Wang, a study investigator at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. “However, despite the growing body of evidence surrounding the benefits of testosterone therapy for those who are hypogonadal, men are often unaware that the symptoms they are experiencing can be attributed to low testosterone and, therefore, are left undiagnosed and untreated.”

The analysis presented is based on a new subset evaluation of a six-month safety and efficacy study of AndroGel published in 2000, from which researchers originally concluded that AndroGel was effective in restoring testosterone levels and in some cases, superior to a transdermal testosterone patch. In 2004, an additional follow-up, 36-month, open-label extension study was published that showed that AndroGel was safe for men to use over the long term.

Study Highlights

The study presented at ENDO examined the relationship between BMI and sex hormones in hypogonadal men both before and after treatment with testosterone. The study found:

• Neither testosterone nor free testosterone is significantly related to BMI either before or after testosterone treatment.
• Testosterone treatment decreases SHBG more in lean men than in obese men, suggesting that SHBG is more influenced by the serum E2 and E2/testosterone ratio than testosterone levels.
• Interactions of obesity, sex hormone-binding globulin (SHBG) and serum testosterone in men with low testosterone are complex both at baseline and after testosterone treatment.

“We are pleased that the AndroGel pivotal data continue to aid physicians and researchers in helping to treat men suffering from the symptoms associated with low testosterone, as we learn more everyday about the appropriate treatments for this patient population,” said Dr. Stephen Hill, president and chief executive officer, Solvay Pharmaceuticals, Inc.

About Low Testosterone

It is estimated that hypogonadism, also known as low testosterone, affects more than 13 million men in the United States age 45 and older. Because signs and symptoms of low testosterone are subtle and often overlap with other common medical conditions, low testosterone is frequently undiagnosed. Signs and symptoms of low testosterone include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density.

Men with chronic conditions, such as obesity,  diabetes, high blood pressure (hypertension), high cholesterol and asthma/COPD, are also more likely to have low testosterone compared to other men. Below normal levels of testosterone can be confirmed by a blood test. Testosterone treatment is designed to elevate a hypogonadal male’s testosterone levels into the normal physiologic range, which may alleviate symptoms related to low testosterone. As with any medication, patients should work with their physician to weigh treatment benefits and risks.

About AndroGel®

AndroGel, the first U.S. Food and Drug Administration (FDA)-approved testosterone gel available in a non-aerosol, metered-dose pump, is a once-daily, clear, odorless topical testosterone gel approved in 2000 for replacement therapy in men ages 18 and older for conditions associated with a deficiency or absence of endogenous testosterone. AndroGel is the most prescribed form of testosterone therapy for adult males in the United States.

Pivotal data showed that AndroGel was effective in restoring testosterone levels to normal and in some cases, superior to a transdermal testosterone patch.

• AndroGel was effective in improving sexual function, mood, and muscle strength; increasing lean body mass; and decreasing body fat.
• It was demonstrated that AndroGel was more effective than a testosterone patch in increasing lean body mass and decreasing body fat, and had comparable effects with other symptoms.
• Because of minimal skin irritation, subjects using AndroGel also had higher compliance rates.
• In a 2004 open-label, follow-up extension study, AndroGel was shown to be safe for men to use over the long term.

The AndroGel pump is designed to deliver 1.25 grams of testosterone gel per pump depression, and it is also available in 2.5 and 5 gram packets. This gives patients two convenient ways to use AndroGel and offers physicians added flexibility to move, if necessary, from the starting dose of 5g per day to 7.5g or from 7.5g to 10g per day.

AndroGel must not be used if you have known or suspected prostate cancer or breast cancer (a rare condition for men). AndroGel must not be used by women who are pregnant, may become pregnant, or breastfeeding, as testosterone may cause fetal harm. The major risks of AndroGel include prostate enlargement, prostate cancer, and transfer of testosterone to others (including women and children). Transference can occur when vigorous skin-to-skin contact is made with the application site and can be minimized by washing your hands after application and covering the application site with clothing.

The most common adverse events reported are skin irritation where gel is applied, breast development or tenderness, acne, prostate enlargement, changes in lab test results, and changes in urinary habits.

Remember, this information does not take the place of the advice you get from your doctor or other health care professional. Always talk with your doctor if you have questions about AndroGel.

Unimed Pharmaceuticals, LLC., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., holds the exclusive rights to AndroGel in the United States.