To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Bio-Technology General Launches Oxandrin To Promote Weight Gain URL: http://www.pslgroup.com/dg/60C2.htm Doctor's Guide December 5, 1995
ISELIN, N.J. -- Dec. 5, 1995 -- Bio-Technology General Corp. (NASDAQ: BTGC) today announced its first major U.S. drug launch: Oxandrin(R) (oxandrolone), an oral anabolic agent indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma. Oxandrin(R) is also indicated for patients who, without definite pathophysiologic reasons, fail to gain or maintain normal weight. For reasons that are not clear, many chronic and acute disease processes are known to cause involuntary weight loss. These include certain types of cancer, AIDS, burns, chronic obstructive pulmonary disease, gastrointestinal disorders, renal failure and sepsis. Regardless of the etiology, these disorders result in a state of malnutrition which depletes lean body mass. Such involuntary weight loss can directly contribute to mortality if not stopped or reversed. On announcing the launch, Sim Fass, president and chief executive officer of Bio-Technology General, stated: "The availability of Oxandrin(R), the only oral anabolic agent indicated for weight gain, is particularly timely since the serious nature and consequences of involuntary weight loss have only recently become better appreciated by the medical community. We believe many patients can benefit from this safe, effective and convenient oral treatment for weight loss." According to Dr. Adrian Dobs, director of the Endocrinology Clinical Studies Unit at Johns Hopkins: "While the underlying causes of involuntary weight loss are not fully understood, such loss results in an increased breakdown of protein in the body, and the gradual loss of lean body mass. This can contribute to increased morbidity and mortality. In conjunction with proper diet and exercise, anabolic therapy may prove beneficial to hundreds of thousands of patients in the United States suffering from weight loss." Oxandrin(R) is a synthetic anabolic agent similar in structure to testosterone. However, Oxandrin(R) differs from most forms of testosterone in that it is administered orally, making it more convenient to use. Importantly, it has also been shown to exhibit significantly more anabolic activity than testosterone. In comparison to the few other oral anabolic steroids, Oxandrin(R) is unique in that it is not primarily metabolized in the liver. The recommended adult dose of Oxandrin(R) is 2.5 mg to 20mg per day. At an average wholesale price of $3.75 per 2.5 mg tablet, Oxandrin(R) is a cost effective therapy for involuntary weight loss. As with all anabolic agents, Oxandrin(R) is classified as a Schedule III controlled substance and has been assigned a class black box warning relating to liver and coronary artery disease. As separately announced today, BTG and Quantum Health Resources, Inc. (NASDAQ: QHRI) have forged a comprehensive relationship to enhance the commercialization of BTG.'s products. Oxandrin(R), available only by physician prescription, will be distributed by Quantum Express(TM), a business unit of Quantum Health Resources, to ensure that patients have access to Oxandrin(R) in the most responsible and expedient manner. Quantum Health Resources is an innovative provider and distributor of alternate site therapies and offers support services for people affected by rare chronic disorders. William Pursley, senior vice president at BTG, said, "We believe our new relationship with Quantm Health Resources will define innovative and optimal distribution for products like Oxandrin(R) in today's health care environment. Quantum's expertise complements perfectly BTG's skilled and experienced specialty sales force to maximize appropriate patient access and provide needed patient, physician and payer services." Health care professionals can receive more information about Oxandrin(R) through their BTG Area Manager or via a toll-free number (1-800-741-2698). The phone line is staffed by customer service representatives from Quantum, who will coordinate the distribution of Oxandrin(R), and aid in reimbursement issues. The Carenet(TM) Foundation, a non-profit organization, will assess financial eligibility and administer patient assistance programs sponsored by BTG.. In addition to now being commercially available for weight gain following weight loss, Oxandrin(R) is also available through Quantum under a treatment IND for two disorders affecting growth: constitutional delay of growth and puberty (CDGP) in boys, and Turner's syndrome in young girls. BTG's clinical program over the past several years has included pursuit of the potential of Oxandrin(R) in the indications of alcoholic hepatitis and AIDS wasting. The company plans to continue its clinical research in these indications through Phase III studies that will focus on optimal dosing for both conditions. CDGP, Turner's syndrome, alcoholic hepatitis and AIDS wasting indications have been granted Orphan Drug designation by the FDA. This designation is granted to drugs for rare diseases or conditions with a prevalence of less than 200,000 cases in the United States and provides the manufacturer with seven years of market exclusivity post approval. Based in Iselin, N.J. BTG is an international company involved in the research, development, manufacture and marketing of health care products, with a primary focus on treatments for endocrine and metabolic disorders. The company currently has five products approved or marketed in 29 countries worldwide, as well as a promising near-term pipeline. CONTACT: Bio-Technology General Corp. | Leah Berkovits, 908/632-8800 | or | Investor Relations | Don Weinberger, 516/829-7111 --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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