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Bio-Technology General Launches Oxandrin To Promote Weight Gain.


ISELIN, N.J.--(BUSINESS WIRE)--Dec. 4, 1995--Bio-Technology General Corp. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: BTGC BTGC Bio-Technology General (stock symbol)
BTGC Bukit Tinggi Golf Club (Malaysia) 
) today announced its first major U.S. drug launch: Oxandrin(R) (oxandrolone), an oral anabolic anabolic

pertaining to or arising from anabolism.


anabolic steroid
steroids with a tissue-building effect. Testosterone is an example of a natural anabolic steroid with the, sometimes undesirable, effect of causing masculinization.
 agent indicated as adjunctive therapy adjunctive therapy Medtalk A therapeutic maneuver(s) with an ancillary role in treating a disease by ↓ M&M, but not part of the immediate therapy required to stabilize the Pt. Cf Adjuvant 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 chronic obstructive pulmonary disease
n. Abbr. COPD
A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced.
, gastrointestinal disorders, renal failure renal failure
n.
Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema,
 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 Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
. 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 Anabolic steroids
A group of drugs derived from the male sex hormone testosterone, most commonly prescribed to promote growth or to help the body repair tissues weakened by severe illness or aging. Some anabolic steroids are given as appetite stimulants.
, 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 controlled substance n. a drug which has been declared by federal or state law to be illegal for sale or use, but may be dispensed under a physician's prescription.  and has been assigned a class black box warning relating to liver and coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. .

As separately announced today, BTG BTG BIT (Built-In Test) Target Generator
BTG Bridging the Gap
BTG British Technology Group
BtG Betreuungsgesetz (Germany)
BTG Biomass Technology Group BV
BTG Begbies Traynor Group
 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 support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other 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 CDGP Citizen-Driven Government Performance
CDGP Constitutional Delay in Growth and Puberty
CDGP Cairns Division of General Practice (Australia)
CDGP Call Data Generation Point
) 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
. 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 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 4, 1995
Words:846
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