BTG Announces FDA Approval of Oral Contraceptive Incorporating BTG's Proprietary Dosing Regimen.

ISELIN, N.J--(BUSINESS WIRE)--April 30, 1998--Bio-Technology General Corp. (NASDAQ:BTGC) today announced that an oral contraceptive, incorporating BTG's patented dosing regimen licensed to an affiliate of Organon, Inc., has received FDA marketing approval. Under the terms of the license agreement, BTG will receive a milestone payment relating to the approval, and royalties on all future sales of the product. Organon, Inc., a West Orange, New Jersey company, intends to launch the product later this year in the United States, the first country in which this advanced technology will be available.

The new dosing regimen reduces the daily estrogen dose from the commonly prescribed 30-35 mcg level to the 20 mcg level, while maintaining cycle control and a favorable tolerability profile. The product's uniqueness is based on BTG's patented shortened hormone-free interval. Dosing begins with 21 days of 20 mcg ethinyl estradiol and 150 mcg desogestrel. The last seven days in the dosing cycle start with two days of placebo pills, followed by five days of 10 mcg ethinyl estradiol pills. In contrast, all other combined oral contraceptives currently available in the U.S. have an initial three-week estrogen/progestin cycle, followed by the traditional one week of placebo pills.

"This is good news for millions of women and their care givers who want new options for birth control," said Dr. Sarah Berga, Associate Professor of OB/GYN, Division of Reproductive Endocrinology, The University of Pittsburgh School of Medicine. "An oral contraceptive with a low daily dose of estrogen and a shortened hormone-free interval is a welcome addition to the oral contraceptives available. Clinical studies of this new drug regimen indicate effective and well tolerated contraception for new patients, patients who change therapy, perimenopausal and postpartum women," said Dr. Berga.

Commenting on the approval, Sim Fass, Chairman, President and Chief Executive Officer of BTG stated: "The oral contraceptive incorporating BTG's regimen contains the lowest efficacious dose of estrogen compared with other oral contraceptive products, thereby minimizing the potential for side effects and break through bleeding. The Company believes, therefore, that Organon may achieve significant success in the $1 billion U.S. oral contraceptive marketplace."

BTG's other commercial products are: Oxandrin(r), an oral anabolic agent for the treatment of weight loss, Bio-Tropin(tm), recombinant human growth hormone, BioLon(tm), hyaluronic acid for use in ophthalmic surgical procedures, and Delatestryl(r), an injectable testosterone product. The Company's worldwide 1997 product sales were $53.7 million. The oral contraceptive product will strengthen both the Company's revenues from product sales and the Company's focus in the area of endocrine and metabolic therapeutic agents.

Organon develops and produces pharmaceutical products in fields such as gynecology, psychiatry, atherothrombosis, and auto-immune diseases. Major product groups are oral contraceptives, infertility treatments, and preparations for menopausal complaints, depression, and psychosis. Organon is one of the pharmaceutical business units of Akzo Nobel, which is headquartered in Arnhem, The Netherlands.

Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human healthcare. -0-

Statements in this news release concerning the Company's business outlook or future economic performance; anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions performance or other matters, are "forward-looking statements" as that term is defined under the Federal Securities Laws. Forward-looking statements are subject to risks, uncertainties and other factors which could cause actual results to differ materially from those states in such statements. Such risks, uncertainties and factors include, but are not limited to, changes and delays in product development plans and schedules, customer acceptance of new products, changes in pricing or other actions by competitors, patents owned by the Company and its competitors, and general economic conditions, as well as other risks detailed in the Company's filings with the Securities and Exchange Commission.

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