New 5 mg Androderm Testosterone Patch Now Available

PHILADELPHIA, and SALT LAKE CITY -- June 12, 1997 -- SmithKline Beecham and TheraTech, Inc. announced today that the new Androderm(R) Testosterone Transdermal System 5 mg One-Patch is now available with a physician's prescription. The companies also announced that results of key clinical studies will be presented at the Endocrine Society Meeting, being held this week in Minneapolis.

The studies include:

• A randomized, steady-state pharmacokinetic study, comparing Androderm 5 mg One-Patch to two simultaneously administered Androderm 2.5 mg patches. The data demonstrated that the Androderm 5 mg One-Patch produces testosterone absorption equivalent to that found in men treated with the 2.5 mg patches.
• Two studies showed that in those subjects who experienced skin reactions without pretreatment, the incidence and severity of skin reactions to Androderm were markedly reduced through pretreatment of the patch application site with 0.1% triamcinolone acetonide (TA) cream, a commonly used topical corticosteroid. Pretreatment with 0.1% TA cream did not significantly alter transdermal absorption of testosterone from the Androderm patch.
• A six-month study that evaluated the effect of testosterone delivered either transdermally with Androderm or by testosterone enanthate (TE) injection on the frequency of an elevated hematocrit (HCT). Results showed that the incidence of elevated HCT was significantly greater among the TE injection group (25%) compared to the Androderm group (8%). (Elevated HCT levels are associated with an increased risk of blood clots.)

Androderm is the only non-scrotal patch available in the U.S. to treat male hypogonadism, a condition in which the body produces insufficient levels of testosterone.

Originally marketed as a two-patch per day, 2.5 mg system, the new Androderm 5 mg One-Patch restores testosterone levels to normal by continuous delivery of testosterone for 24 hours, thus mimicking the daily pattern of testosterone levels of healthy men in a convenient single patch formulation.

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 indicated that testosterone levels may decline 30 to 40 percent in men from their late 40's to their early 70's. Only about five percent of the estimated four to five million American men of all ages with hypogonadism currently receive testosterone replacement therapy.

In adult men, the symptoms of testosterone deficiency include: sexual dysfunction, including loss of libido; fatigue; depressed mood; loss of energy and strength; and in severe cases, regression of secondary sexual characteristics. If left untreated, there is a potential risk of significant, long-term consequences such as osteoporosis, muscle wasting and impotence.

Men diagnosed with testosterone deficiency should discuss the benefits and risks of all treatments with a physician before starting testosterone replacement therapy. With Androderm, mild to moderate skin irritation is the most frequently reported side effect. In clinical trials, 53 percent of patients experienced application site reaction at some time during treatment. Only 5 percent discontinued treatment due to chronic irritation, and 4 percent due to allergic contact dermatitis.

In 1993, SmithKline Beecham acquired exclusive marketing and distribution rights for Androderm from TheraTech, Inc., for the United States, Canada, the United Kingdom and Ireland. TheraTech, Inc. is responsible for the technical and clinical development of the product and manufactures Androderm for SmithKline Beecham. The product has been on the market for this indication since 1995.

SmithKline Beecham is a healthcare company engaged in the discovery, development, manufacturing, and marketing of pharmaceuticals and vaccines, over-the-counter medicines, and 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 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.