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FDA APPROVES SMITHKLINE BEECHAM'S TRIOSTAT(TM) FOR TREATMENT OF MYXEDEMA COMA; RECEIVES ORPHAN DRUG STATUS FOR POTENTIALLY DEADLY SYNDROME

FDA APPROVES SMITHKLINE BEECHAM'S TRIOSTAT(TM) FOR TREATMENT OF MYXEDEMA
 COMA; RECEIVES ORPHAN DRUG STATUS FOR POTENTIALLY DEADLY SYNDROME
 PHILADELPHIA, Jan. 6 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved TRIOSTAT(TM) (liothyronine sodium injection) to treat patients suffering from myxedema coma and precoma, SmithKline Beecham (NYSE: SBH) announced today.
 TRIOSTAT, which has been awarded orphan drug status, is a synthetic injectable form of the thyroid hormone triiodot hyronine, or T3.
 Myxedema coma is a rare, often fatal condition that is the extreme form of hypothyroidism. First reported in 1879 at St. Thomas Hospital in London, myxedema coma strikes approximately 50 to 100 Americans each year, primarily women older than 70 who are being treated for hypothyroidism.
 Myxedema coma is most often encountered during the winter months, giving rise to speculation that external cold may be an aggravating factor. Other events most commonly reported to be associated with the onset of myxedema coma include pneumonia, sepsis, aneurysms, stroke, head trauma, and congestive heart failure.
 "Despite the fact that the market potential for a drug to treat myxedema coma is extremely limited, SmithKline Beecham has made a considerable investment in money and time to bring TRIOSTAT to the market," said Jean-Pierre Garnier, president of SmithKline Beecham's pharmaceutical business in North America.
 Dr. Garnier noted that FDA has assigned an "A" rating to the TRIOSTAT New Drug Application meaning that the product offers an important therapeutic gain over existing myxedema coma therapies.
 Early recognition and treatment are essential in the management of myxedema coma if a fatal outcome is to be avoided. According to Milton Hamolsky, M.D., Professor of Medicine Emeritus at Brown University and an authority on thyroid disease, "TRIOSTAT is ideally suited for patients with myxedema coma or precoma because it is considered to be the active thyroid hormone and, unlike L-thyroxine, it does not need to be metabolically converted to the active state. In sick patients conversion to T3 is inhibited."
 Furthermore, "because the mortality rate of the syndrome is 60 percent or higher, the rapid onset of action could make the difference between life and death. Since use of TRIOSTAT means therapeutic effect begins promptly, it may provide the best opportunity to reverse the comatose state and to prevent precomatose patients from lapsing into a coma," added Dr. Hamolsky.
 The drug will be provided in 1 mL (10 mcg/mL) amber, glass vials. Orphan drug status is given to drugs indicated for treating conditions that affect fewer than 200,000 patients. The designation gives the manufacturer a seven year market exclusivity for the drug in the given indication. The Orphan Drug Act was approved by Congress in 1983 as a way of encouraging research and development of medications for small patient populations with rare disorders.
 SmithKline Beecham, a world leader in health care, markets prescription and consumer medicines, animal health products, and clinical laboratory services. The company was formed in July 1989 through the merger of SmithKline Beckman Corporation and Beecham Group, PLC.
 /delval/
 -0- 1/6/92
 /CONTACT: Jeremy Heymsfeld of SmithKline Beecham, 215-751-5166/
 (SBH) CO: SmithKline Beecham ST: Pennsylvania IN: MTC SU: PDT


MK -- PH003 -- 6745 01/06/92 08:58 EST
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Date:Jan 6, 1992
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