Bio-Technology General Corp., which expects to recordthe first 12-month profit in its 15-year history, hit anothermilestone Monday when the company launched its firstdrug, Oxandrin, in the U.S. for promoting weight gainassociated with a broad range of chronic and acutediseases, such as cancer and AIDS.

Oxandrin, an anabolic steroid, was developed by G.D.Searle & Co., of Skokie, Ill., and approved by the FDA in1964 for combating weight loss. Bio-Technology, ofIselin, N.J., received rights to the drug when it mergedwith Gynex Pharmaceuticals Inc., of Vernon Hills, Ill., in1993.

Bio-Technology General has established a sales force tosell Oxandrin, which is an orally administeredtestosterone analog used for weight gain in diseaseswhere the loss of body mass can result in malnutritionand death. The wholesale price of a 2.5 mg tablet, thelowest recommended daily adult dose, is $3.75.

William Pursley, Bio-Technology's senior vice presidentof marketing, sales and commercial development, saidpotential users of Oxandrin, whose generic name isoxandrolone, are about 500,000 people with such diseasesas cancer, AIDS, gastrointestinal disorders, renal failureand sepsis.

Pursley said sales of Oxandrin in the U.S. are expected toenhance Bio-Technology General's profitability next yearfollowing the company's first full-year profit in 1995,which was achieved through international sales of fiveproducts.

Among the drugs on the market outside the U.S. is Bio-Tropin, the company's human growth hormone drug. Bio-Tropin was approved by the FDA earlier this year, butwas kept off the U.S. market by a preliminary injunctionissued to Genentech Inc., of South San Francisco, whichalleged the drug infringed its patents.

Genentech currently captures 75 percent of U.S. growthhormone sales with it products, Protropin and Nutropin.Eli Lilly and Co., of Indianapolis, which makesHumatrope, has the other 25 percent.

Genentech also won an injunction against Denmark-basedNovo Nordisk A/S preventing sale of its growth hormone,Norditropin, which was approved by the FDA this year.

Bio-Technology General and Novo Nordisk asked afederal appeals court Monday to throw-out theinjunctions, which were issued by a U.S. District judge inNew York last summer. A ruling is expected in lateFebruary or early March.

If the injunctions are upheld, they will continue to preventBio-Technology General and Novo Nordisk from sellingtheir growth hormones until the district court litigation isresolved.

Pursley said now that Bio-Technology General, foundedin 1980, finally has reached profitability Bio-Tropinwould be considered "gravy if and when it gets to theU.S. market."

Bio-Technology General (NASDAQ:BTGC) closedMonday at $3.87, up 25 cents. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.