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The Only Oral Anabolic Agent Indicated for the Treatment of Involuntary Weight Loss

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    The Only Oral Anabolic Agent Indicated for the Treatment of Involuntary Weight Loss

    The Only Oral Anabolic Agent Indicated for the Treatment of Involuntary Weight Loss

    New 10mg OXANDRIN(R) Tablets Now Available ...

    More Convenient Dosage of OXANDRIN May Enhance Patient Compliance

    ISELIN, N.J., Oct. 22 /PRNewswire-FirstCall/ -- Today Bio-Technology General Corp. (Nasdaq:BTGC) announced the availability of the new 10mg strength of OXANDRIN(R) (oxandrolone, USP - CIII) a treatment for involuntary weight loss which can be associated with numerous conditions such as HIV/AIDS, pressure ulcers, non-healing wounds, spinal cord injury, burns and trauma. The anabolic agent can now be given with one 10mg tablet, twice daily for those patients taking 20mg a day, the most common dosage. The new strength can improve patient compliance, which is a key challenge in the treatment of involuntary weight loss.

    "This new, more convenient tablet has the potential to offer patients the opportunity to take far fewer pills a day, while giving physicians more flexibility when offering treatment options," stated Robert Demling, M.D., Professor of Surgery at Harvard Medical School and Director of the Burn-Trauma Center at Brigham and Women's Hospital. "The new strength may improve patient compliance, which could make it easier to combat involuntary weight loss."

    Involuntary weight loss or cachexia is a state of physical malnutrition resulting in the loss of lean body weight that can be associated with various conditions. Involuntary weight loss may account for up to 30 percent of cancer-related deaths(1) and has shown a strong relationship of reduced survival in HIV/AIDS patients, despite the success of highly active antiretroviral treatment (HAART).

    "Combating involuntary weight loss is a serious problem. People living in long-term care facilities are at risk for losing lean body mass, which can make it more difficult to treat their medical conditions," says Nancy Collins, PhD, RD, a registered dietitian and President of the Florida Dietetic Association. "OXANDRIN can help patients regain weight and lean body mass, and the new 10mg strength will make it easier to administer."

    BTGC's 2001 Oxandrin sales were over $47 million. Oxandrin prescriptions for the three and nine months ended September 30, 2002 grew 35% and 18%, respectively, over the comparable periods of 2001. Prescription growth from the second to the third quarter of 2002 was 12%. Retail prescriptions, representing approximately 60% of the total, grew 22% in the first nine months of 2002, compared to the same period in 2001, whereas prescriptions in the long-term care sector grew 18%.

    OXANDRIN has been shown to increase protein synthesis, the metabolic process which can results in lean body mass(2). In a study of patients with HIV related weight loss, when combined with resistance exercise, a daily regimen of 20mg of OXANDRIN has been shown to increase lean body mass by up to 15 pounds in an 8-week period as well as improve physical strength(3).

    In clinical trials involving more than 450 patients, 99 percent of men and women experienced no androgenic side effects(4). Further, in over 30 years of use, safety and tolerability have been demonstrated in men, women and children.

    OXANDRIN is the only oral anabolic agent approved by the FDA as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis. OXANDRIN will now be available in both 2.5mg and 10mg strengths.

    OXANDRIN is marketed by Bio-Technology General Corp., a biopharmaceutical company, which develops, manufactures and markets genetically engineered and other products for human health care worldwide. Additional information about OXANDRIN can be found at .

    (1) Strasser F. Update on anorexia and cachexia. Hematol Oncol Clin North

    Am. 2002; 16(3):589-617.

    (2) Sheffield-Moore M, Urban RJ, Wolf SE, et al. Short-term oxandrolone

    administration stimulates net muscle protein synthesis in young men.

    J Clin Endocrinol Metab. 1999;84:2705-2711.

    (3) Strawford A, Barbieri T, Van Loan M, et al. Resistance exercise and

    supraphysiologic androgen therapy in eugonadal men with HIV-related

    weight loss: a randomized controlled trial. JAMA. 1999;281:1282-1290.

    (4) Data on file. BTG Pharmaceuticals; Iselin, NJ 08830