Androderm(R) Cleared by FDA for Testosterone Replacement Therapy

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PHILADELPHIA and SALT LAKE CITY, Oct. 2, 1995 - SmithKline Beecham (NYSE:

SBH) and TheraTech, Inc. (Nasdaq: THRT) today announced that Androderm(R)

(Testosterone Transdermal System) has been cleared for marketing by the

U.S. Food and Drug Administration (FDA) as a treatment for men suffering

from hypogonadism, a condition in which the body produces insufficient

levels of testosterone. Only about 250,000 of the estimated four to five

million American men of all ages with hypogonadism currently receive

testosterone replacement therapy.

"Androderm is an important development in testosterone replacement

therapy," said Wayne Meikle, M.D., professor of medicine and pathology,

University of Utah, and Androderm clinical investigator.

"This new delivery system represents a patient-friendly alternative for

hypogonadal men currently under treatment, as well as the large number of

men who remain undiagnosed and untreated."

In 1993, SmithKline Beecham (SB) 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 will manufacture Androderm for SB.

"FDA clearance of Androderm brings to fruition years of dedicated research,

product development and clinical testing," noted Dr. Dinesh C. Patel,

TheraTech president and chief executive officer. "This action is especially

significant because Androderm is the first TheraTech product to reach this

important milestone."

A transdermal patch applied to the body to deliver therapeutic levels of

testosterone, Androderm helps relieve symptoms associated with primary

hypogonadism (disorders of the testes) and secondary hypogonadism

(disorders of the pituitary and/or hypothalamus). Symptoms and signs

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,

male fat distribution, deep voice and male hair distribution (i.e., chest

and facial).

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 testosterone

levels in 92 percent of the 94 patients who completed the trials. In a

subset of 29 patients withdrawn from their previous testosterone

replacement therapy for eight weeks, 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.

An Alternative To Current Methods

Intramuscular injections of testosterone -- a widely prescribed

testosterone replacement therapy -- are administered every two to four

weeks, creating abnormal peaks and troughs in testosterone levels. In

contrast, the nightly application of two Androderm patches delivers

approximately 5 mg testosterone over a 24-hour period, producing

testosterone levels that mimic the daily pattern of testosterone levels in

healthy men.

Unlike the scrotal testosterone patch, introduced in 1994, which is applied

to the shaved scrotum, Androderm can be worn on the abdomen, back, thighs,

or upper arms.

"Androderm offers a physiologic alternative for hormone replacement for

hypogonadal men," said Stefan Arver, M.D., associate professor at the

Karolinska Institute and Androderm clinical investigator. "Further, the

ease of use of Androderm may result in greater patient compliance."

Role of Testosterone

The active ingredient in Androderm is testosterone, the body's naturally

occurring hormone which, in addition to being responsible for developing

adult male physical characteristics during and after puberty, is also

critical for erectile function, libido, normal energy level and mood.

There are many causes of testosterone deficiency, including conditions of

the testes (such as testicular injury or infection, and Klinefelter's

syndrome-a chromosomal abnormality), and disorders of the pituitary and

hypothalamus.

Undertreated Condition

Only about five percent of the estimated four to five million American men

of all ages with hypogonadism currently receive testosterone replacement

therapy.

"Unfortunately, most men aren't comfortable discussing the symptoms of

testosterone deficiency--such as a decrease in sexual interest, erectile

function, or depressed mood and fatigue--with family members, friends, or

even their own doctors," said Adrian S. Dobs, M.D., M.H.S., associate

professor of medicine, Johns Hopkins University School of Medicine, and

Androderm clinical investigator. "Because of that, many men may go

undiagnosed and untreated. Physicians and their male patients need to

establish a dialogue where topics of this nature can be freely discussed."

Collaboration Between SmithKline Beecham and TheraTech

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. TheraTech, which develops drug products both

independently and with partners, has development and marketing agreements

with leading pharmaceutical companies including SmithKline Beecham, Pfizer,

Procter & Gamble, Astra, Solvay, Greland and Tsumura.

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.

CONTACT: (Media) Sharyn Arnold, 215-751-7074, or Scott Taylor,

212-223-8200, or (Investor Relations) Richard Williams, 215-751-7002, all

of SmithKline Beecham; or (Investor Relations) Alexander L. Searl, or Alan

Behunin, 801-588-6200, both of TheraTech (SBH THRT)

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