Testosterone Replacement Therapy Now Available in New Dosage

PHILADELPHIA, and SALT LAKE CITY, May 5, 1997 -- SmithKline Beecham and TheraTech, Inc. announced that a new 5 milligram per day formulation of Androderm® (Testosterone Transdermal System), has been cleared for marketing by the U.S. Food and Drug Administration (FDA). Androderm is the only non-scrotal patch available in the U.S. to treat male hypogonadism or testosterone deficiency. It was originally marketed as a two-patch, 2.5 milligram (mg) system.

The new 5 milligram Androderm patch restores testosterone levels to a normal range by continuous delivery of testosterone for 24 hours, thus mimicking the daily pattern of testosterone levels in healthy men in a convenient single patch formulation.

"Testosterone deficiency is increasingly recognized for what it is -- a relatively common condition with significant, long-term health consequences, requiring medical treatment," said A. Wayne Meikle, M.D., professor of medicine, University of Utah School of Medicine and Androderm clinical investigator. "The availability of a single, non-scrotal patch is a significant step forward in convenience and should ultimately motivate more men to comply with treatment."

Treatment Advantages

In addition to its convenience, Androderm mimics the natural testosterone cycle, eliminating the non-physiological peaks and troughs associated with intramuscular (IM) injections of testosterone. IM therapy usually requires injections of testosterone every two to three weeks, administered in a physician's office.

For most men with hypogonadism or testosterone deficiency, the recommended Androderm dose is 5 mg per day. Unlike the scrotal patch which must be applied to a shaved scrotum, the Androderm 5 mg patch is applied nightly to non-scrotal skin (back, abdomen, thighs, upper arms). In addition, the Androderm 5 mg patch can be worn during sex or while bathing or swimming. For the small percentage of patients requiring alternative dosing, the 2.5 mg Androderm patch will continue to be available. The Androderm 5 mg patch will be available through a physician's prescription.

Testosterone Deficiency: Symptoms and Prevalence

Almost ninety-five percent of the more than five million American men estimated to be testosterone deficient remain untreated, potentially placing them at risk for long-term medical consequences. Symptoms, signs and consequences of testosterone deficiency include: sexual dysfunction, including loss of libido and impotence; fatigue; depressed mood; muscle wasting; osteoporosis; and the absence or regression of secondary sexual characteristics, such as muscle development, deep voice and male hair distribution (i.e., chest and facial).

Hypogonadism (testosterone deficiency) may be caused by conditions of the testes (such as testicular injury, and Klinefelter's syndrome, a chromosomal abnormality), and disorders of the pituitary and hypothalamus. In addition, testosterone declines as men age; in some elderly men, testosterone levels fall into the hypogonadal range. Some studies indicate that testosterone levels may decline 30 to 40 percent in men from their late 40s to their early 70s.

Testosterone replacement therapy is contraindicated in men with known or suspected prostate cancer. While, it has not been shown to cause prostate cancer, testosterone replacement therapy may promote the growth of existing prostate cancer. Therefore, prostate cancer should be ruled out in geriatric patients or others at high risk before initiating testosterone replacement therapy. In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for men with normal levels of testosterone.

Corporate Background

In 1993, SmithKline Beecham acquired exclusive marketing and distribution rights, from TheraTech, for Androderm for the United States, Canada, the United Kingdom and Ireland. TheraTech was responsible for the technical and clinical development of the product and is manufacturing Androderm for SmithKline Beecham. The product, available only by a doctor's prescription, was originally cleared for marketing by the FDA in late September 1995 and quickly became the leading patch therapy for treating testosterone deficiency.

SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals and vaccines, over-the-counter medicines, health related consumer products, and provides healthcare services including clinical laboratory testing, disease management, and pharmaceutical benefit management.

TheraTech, Inc., headquartered in Salt Lake City, Utah, is a leading developer of innovative, controlled-release transdermal, transmucosal, oral, topical, and pulmonary drug delivery products. The company's development pipeline holds more than 20 products spanning a wide variety of delivery technologies and therapeutic areas.