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| | | ![]() Atmos Testosterone Transdermal Patch Now Approved in Sweden SALT LAKE CITY and SODERTALJE, Sweden, August 14, 1996 -- TheraTech Inc. (NASDAQ:THRT) and Astra AB Wednesday announced that Astra AB has begun marketing the Atmos(R) testosterone transdermal patch in Sweden. Atmos, which was developed by TheraTech, is intended for the treatment of male hypogonadism, a syndrome in which the body produces insufficient amounts of the male hormone, testosterone. The patch employs TheraTech's proprietary permeation enhancers, anti-irritants and liquid reservoir system design, and is manufactured by TheraTech in its Salt Lake City production facility. Testosterone, a naturally occurring hormone, is essential for the development and maintenance of male physical and sexual characteristics. Studies in the United States and Europe have indicated that men of all ages can be affected by hypogonadism, the symptoms of which include impotence, decreased libido, fatigue and depression. Prior to introduction of the patch, treatment of hypogonadism was primarily given by intra-muscular injections of a testosterone ester administered every two to four weeks. The testosterone patch is intended to replace these injections by delivering, on a daily, patient-friendly basis, the amount of natural testosterone normally produced by the body. The patch can be applied to numerous sites on the body, and produces physiological levels of testosterone and its metabolites, mimicking those seen in healthy young men. Clinical trials evaluating the efficacy and safety of the testosterone patch were previously conducted in the United States and Sweden. Based on these studies, the testosterone patch was cleared for marketing by the U.S. Food and Drug Administration in September 1995. It is marketed in the United States by SmithKline Beecham under the trade name Androderm(R). Sweden is the second European country in which the product has become available. On July 31, the product was launched by SmithKline Beecham in the United Kingdom. In addition to Sweden, Astra also will market Atmos in Denmark, Norway, Finland and Iceland. Regulatory agency marketing approval for these countries is anticipated shortly. Astra AB is headquartered in Sodertalje, Sweden and is one of the fastest growing pharmaceutical companies in the world with total sales of $5.4 billion in 1995. 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 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 Pfizer, Procter & Gamble, SmithKline Beecham, Solvay Pharmaceuticals, Syntex/Roche, Wyeth-Ayerst, Grelan, Sam Yang, Nichiiko and Tsumura.
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