Bio-Technology General Corp. Initiates Efficacy Study of BioHy-TM for the Treatment of Osteoarthritis of the Knee.

ISELIN, NJ--(BUSINESS WIRE)--Aug. 30, 1999--

Bio-Technology General Corp. (NASDAQ:BTGC) today announced that it has initiated a safety and efficacy study of BioHy(TM), its high molecular weight sodium hyaluronate product, for the treatment of pain associated with osteoarthritis of the knee. The randomized, double blind study will compare BioHy with the current lead commercial product in the European viscoelastic market for osteoarthritis of the knee. The study, which is being conducted in Germany, will enroll 250 patients for a series of intra-articular injections of BioHy or the competitor's product into the knee, and is expected to be completed in the first half of 2000. Demonstration of comparable safety and efficacy of BioHy would lead to a regulatory submission for approval to market the product in Europe.

Injections of sodium hyaluronate into the knee have been shown to reduce pain associated with osteoarthritis of the knee by augmenting elastoviscosity within the joint. The current worldwide market for viscoelastic products for osteoarthritis of the knee is approximately $400 million, and is expected to grow as the aging population increases.

BTG's Chairman and CEO, Sim Fass, stated: "The increasing elderly population is creating a greater need and larger market potential for viscoelastic products for osteoarthritis. We believe, therefore, that BioHy could have an important role to play in the market for such products."

Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human health care. BTG's products are marketed in over thirty countries worldwide.

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 stated 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.