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| |  Androderm is now Available Nationwide PHILADELPHIA, SALT LAKE CITY, Nov. 29, 1995 - SmithKline Beecham (NYSE: SBH) and TheraTech, Inc. (Nasdaq: THRT) announced today that Androderm(R) (Testerone Transdermal System) is now available nationwide. Androderm is a treatment for men suffering from hypogonadism, a condition in which the body produces insufficient levels of testosterone. The product, available only by a doctor's prescription, was cleared for marketing by the U.S. Food and Drug Administration (FDA) in late September 1995. Only about five percent of the estimated four to five million American men of all ages with hypogonadism currently receive testosterone replacement therapy (TRT). "The currently available choices given hypogonadal men in need of testosterone replacement therapy have been less than ideal," said Daniel Tasse, vice-president and director, endocrine and oncology products, SmithKline Beecham. "Androderm will fill a distinct need in the area of hormone replacement therapy for men." "The launch of Androderm is a significant event," noted Dr. Dinesh C. Patel, TheraTech's president and chief executive officer, "not only for TheraTech and SmithKline Beecham, but even more for the many testosterone-deficient men who now can avail themselves of this patient- friendly, physiological treatment." Clinical Trial Results The safety and efficacy of Androderm have been demonstrated in open- label, multi-center clinical trials involving hypogonadal men ranging in age from 15 to 65 years. The principal study centers were University of Utah, Johns Hopkins University, and Karolinska Hospital in Stockholm, Sweden. Overall, treatment with Androderm resulted in normalization of morning testosterone levels in 92 percent of the 94 patients who completed the trials. In a key eight-week study of 29 patients who were withdrawn from their previous testosterone replacement therapy, Androderm produced improvements in erectile function, libido and mood, and decreases in complaints of fatigue. The most common side effects reported for Androderm were temporary mild to moderate redness or itching at the sites of application. However, only nine percent of patients discontinued treatment due to skin irritation. "Androderm is a physiologic and convenient alternative to previously available therapy for male hormone replacement," said Adrian S. Dobs, M.D., M.H.S., associate professor of medicine, Johns Hopkins University School of medicine and Androderm clinical investigator. "Hopefully because of its safety, efficacy and ease of use, the many hypogonadal men who remain untreated will seek therapy." About Hypogonadism and Androderm Hypogonadism may be caused by conditions of the testes (such as testicular injury or infection, and Klinefelter's syndrome, a chromosomal abnormality), and disorders of the pituitary and hypothalamus. Symptoms, signs, and consequences of hypogonadism 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). A transdermal patch applied to the body -- abdomen, back, thighs, or upper arms -- Androderm helps relieve those symptoms. For most men, the recommended dosage of Androderm is two patches applied nightly. This delivers 5 mg of testosterone over the following 24 hours, and produces testosterone levels that closely approximate the daily pattern of testosterone levels in healthy men. The average retail price of Androderm is approximately $97.50/month. About SmithKline Beecham and TheraTech In 1993, SmithKline Beecham acquired exclusive marketing and distribution rights for Androderm for the United States and Canada, selected European territories, Australia and New Zealand, from TheraTech. TheraTech was responsible for the technical and clinical development of the product and is manufacturing Androderm for SmithKline Beecham. 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 clinical laboratory testing services. TheraTech, Inc., headquartered in Salt Lake City, Utah, is a leading developer of innovative, controlled-release transdermal, oral, topical, and transmucosal drug delivery products. The company's development pipeline holds over 20 products spanning a wide variety of delivery technologies and therapeutic areas. CONTACT: Sharyn Arnold (Media), 215-751-7074, or Scott Taylor (Media), 212-223-8200, or Richard Williams (Investor Relations), 215-751-7002, for SmithKline Beecham; or Alexander L. Searl (Investor Relations) or Alan Behunin (Investor Relations), 801-588-6200, both for TheraTech/ (SBH THRT)
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