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New Subset Analysis of AndroGel(R) Data Highlights Efficacy - Regardless of BMI

Wednesday, June 18, 2008 General News
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MARIETTA, Ga., June 17 Solvay Pharmaceuticals, Inc.announced today that a new analysis of pivotal study data conducted by the LosAngeles Biomedical Research Institute at Harbor-UCLA Medical Center showedthat initial treatment response of hypogonadal men with AndroGel(R)(testosterone gel) 1% CIII had similar effects on subjects, regardless ofweight and body mass index (BMI). These study results were presented today atthe 2008 Endocrine Society Annual Meeting (ENDO) in San Francisco.
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"Multiple studies have shown that obese men are at an increased risk ofhaving low testosterone levels, so these new findings provide importantinsight into optimal treatment regimens for hypogonadal men," said Dr.Christina Wang, a study investigator at the Los Angeles Biomedical ResearchInstitute at Harbor-UCLA Medical Center. "However, despite the growing bodyof evidence surrounding the benefits of testosterone therapy for those who arehypogonadal, men are often unaware that the symptoms they are experiencing canbe attributed to low testosterone and, therefore, are left undiagnosed anduntreated."
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The analysis presented is based on a new subset evaluation of a six-monthsafety and efficacy study of AndroGel published in 2000, from whichresearchers originally concluded that AndroGel was effective in restoringtestosterone levels and in some cases, superior to a transdermal testosteronepatch. In 2004, an additional follow-up, 36-month, open-label extension studywas published that showed that AndroGel was safe for men to use over the longterm.

Study Highlights

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

"We are pleased that the AndroGel pivotal data continue to aid physiciansand researchers in helping to treat men suffering from the symptoms associatedwith low testosterone, as we learn more everyday about the appropriatetreatments for this patient population," said Dr. Stephen Hill, president andchief executive officer, Solvay Pharmaceuticals, Inc.

About Low Testosterone

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

Men with chronic conditions, such as obesity, diabetes, high bloodpressure, high cholesterol and asthma/COPD, are also more likely to have lowtestosterone compared to other men. Below normal levels of testosterone canbe confirmed by a blood test. Testosterone treatment is designed to elevate ahypogonadal male's testosterone levels into the normal physiologic range,which may alleviate symptoms related to low testosterone. As with anymedication, patients should work with their physician to weigh treatmentbenefits and risks.

About AndroGel(R)

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

Pivotal data showed that AndroGel was effective in restoring testosteronelevels to normal and in some cases, superior to a transdermal testosteronepatch.

The AndroGel pump is designed to deliver 1.25 grams of testosterone gelper pump depression, and i
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