Bio-Technology General Corp. Receives U.S. Patent for Factorex Anti-Coagulant Product.

ISELIN, N.J.--(BUSINESS WIRE)--Sept. 24, 1998--Bio-Technology General Corp. (NASDAQ:BTGC) announced today that it has received notice from the United States Patent and Trademark Office of the issuance of U.S. Letters Patent No. 5,783,421 relating to BTG's Factorex(TM) genetically engineered factor Xa inhibitor agent.

BTG is currently engaged in pre-clinical studies with Factorex to evaluate its potential utility as a novel anti-coagulant. The Company intends to proceed to clinical studies with the product in 1999. The issued patent relates to the DNA encoding BTG's Factorex and to expression of Factorex polypeptide. Three additional U.S. patent applications relating to Factorex have been allowed and are expected to issue over the coming months.

Commenting on the newly issued patent, Sim Fass, President and Chief Executive Officer of BTG, stated: "Factorex has shown early promise in our pre-clinical studies, and we regard this patent as an important element in securing a proprietary position for the product. The expected issuance of additional Factorex patents should help to further our development program for the product."

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 up to 30 countries worldwide. In the United States, Oxandrin(R) (oxandrolone, USP), and Delatestryl(R) (testosterone enanthate), are marketed by BTG, and Mircette(TM) (oral contraceptive) is marketed by BTG's licensee, Organon, Inc. The Company's BioLon(TM) (hyaluronic acid) will be launched in the United States this year by BTG's licensee, Akorn, Inc. BTG's product sales and diluted earnings per share for the first six months of 1998 were $32.7 million and $0.16, respectively.

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.