To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Androderm Cleared by FDA for Testosterone Replacement Therapy URL: http://www.pslgroup.com/dg/2004A.htm Doctor's Guide October 2, 1995
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) --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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