Boston study to evaluate new testosterone patch for treatment of women with AIDS wasting syndrome.

BOSTON--(BUSINESS WIRE)--Sept. 4, 1996--The Massachusetts General Hospital, a teaching hospital of the Harvard Medical School, and TheraTech Inc. (NASDAQ:THRT), Salt Lake City, Wednesday announced initiation of a pilot study to assess a new approach for treating women with the AIDS wasting syndrome.

The treatment uses an experimental testosterone skin patch, developed by TheraTech, to administer low, physiological doses of the natural hormone testosterone to women.

It is estimated that in 1995 the number of newly diagnosed AIDS cases in U.S. women increased by 17 percent, compared with a 3 percent increase in U.S. men. Many women with advanced HIV infection develop a wasting syndrome that is characterized by unintentional weight loss and a critical and disproportionate loss of muscle tissue. This extreme loss of weight and muscle mass is thought to contribute to the severe weakness and fatigue associated with advanced HIV disease.

The cause of the AIDS wasting syndrome is not known. However, studies in men, and more recently in women, suggest that weight loss and decreased lean body mass may correlate with progressive hormonal dysfunction, including diminishing levels of the anabolic hormone testosterone.

More often thought of as the "male hormone," testosterone is also present in healthy women, although at about 20-fold lower levels than in men. Recent data suggest that testosterone is important for maintaining weight and muscle mass in both men and women. Testosterone replacement studies in HIV positive men are currently ongoing at a number of institutions, including the Massachusetts General Hospital.

Preliminary studies, also conducted at the Massachusetts General Hospital, indicate that women with AIDS, particularly those with the wasting syndrome, have lower testosterone levels than do healthy women. This suggests that the use of a physiologic testosterone replacement therapy may benefit this group.

The investigators hope that by restoring testosterone levels to the normal range for women, the testosterone skin patch will help women with the wasting syndrome to maintain and/or gain weight. In addition, the study will determine if restoring normal testosterone levels reduces the often profound fatigue that contributes to the reduced quality of life suffered by this population. In this regard, the testosterone patch is the first experimental therapy created specifically for women with the AIDS wasting syndrome.

The study is being conducted at the Neuroendocrine Unit of the Massachusetts General Hospital under the direction of Steven Grinspoon, M.D., an instructor in Medicine at the Harvard Medical School. Patients enrolled in the study will receive treatment with the testosterone skin patches or analogous placebo patches for a three month period, during which time measurements of hormone levels, body weight, muscle mass and quality of life will be performed. Since this initial pilot study is being conducted exclusively at the Massachusetts General Hospital, treatment with the experimental testosterone patch for women will not be available elsewhere in the United States.

TheraTech Inc., headquartered in Salt Lake City, is a leader in the development of innovative products based on controlled release drug delivery technologies, which it develops independently as well as with corporate partners. TheraTech's products include the Androderm(R) testosterone transdermal system for men, a variety of other transdermal patches, oral transmucosal products for delivery of peptide drugs, oral controlled release products and topical preparations.

TheraTech currently has equity and/or research and licensing agreements with many of the world's leading pharmaceutical companies including Astra AB, Pfizer, Procter & Gamble, SmithKline Beecham, Solvay Pharmaceuticals, Syntex/Roche, Wyeth-Ayerst, Grelan, Nichiiko, Sam Yang and Tsumura.

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NOTE: Any statements released by TheraTech Inc. that are forward looking are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Editors and investors are cautioned that forward looking statements involve risk and uncertainties which may affect the company's business prospects and performance. This includes economic, competitive, governmental, technological and other factors discussed in the company's filings with the Securities and Exchange Commission on forms 10-K, 10-Q and 8-K.

CONTACT: TheraTech Inc., Salt Lake City

Alexander L. Searl or Alan Behunin, 801/588-6200

or

Massachusetts General Hospital, Boston

Sue McGreevey, 617/724-2764