Bio-Technology General Corp. Receives European Approval for BioHy Osteoarthritis Product.

Business Editors/Health & Medical Writers

ISELIN, N.J.--(BUSINESS WIRE)--Nov. 14, 2000

Bio-Technology General Corp. (NASDAQ:BTGC) today announced that it has received marketing approval from the European medical device certification body ("mdc") for BioHy(TM) in the treatment of osteoarthritis. The product will be marketed by BTG's licensee, DePuy Orthopaedics Inc. ("DePuy"), a Johnson & Johnson company. This approval permits marketing of BioHy in all EC countries.

DePuy will launch BioHy under a different, but as yet undisclosed, name in Europe early in 2001 under an exclusive licensing agreement entered into earlier this year between BTG and DePuy. That agreement granted DePuy worldwide BioHy marketing rights in all countries except Japan and Israel. In addition to the pending European launch, DePuy will undertake regulatory approval efforts in the United States and other countries of the licensed territory. The current worldwide market for viscoelastic products for osteoarthritis is approximately $400 million, and is expected to grow as the aging population increases.

Commenting on the approval, Sim Fass, Chairman and CEO of Bio-Technology General Corp., stated: "BioHy is the eighth approved pharmaceutical product from BTG's pipeline. In this instance, we are particularly pleased that BioHy has been approved by mdc, because it authorizes marketing of the product simultaneously throughout the member countries of the European Community. We believe that DePuy, one of the world's leading orthopedic companies, is well positioned to successfully compete in the marketplace for viscoelastic products for osteoarthritis."

BioHy, which is an injectable product classified in Europe as a medical device, is BTG's proprietary formulation of high molecular weight sodium hyaluronate. The product is made by a patented fermentation method, which results in ultra-high purity and the absence of animal-derived proteins. In the Company's clinical safety and efficacy study of the product, injections of BioHy into the knee were shown to help reduce pain associated with osteoarthritis of the knee.

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 30 countries worldwide. Products sold in the United States are Oxandrin(R) (oxandrolone, USP), and Delatestryl(R) (testosterone enanthate), marketed directly by BTG, Mircette(TM) (oral contraceptive), marketed by Organon, Inc., and BioLon(TM) (sodium hyaluronate), marketed by Akorn, Inc. Products sold internationally are Bio-Tropin(TM) (recombinant human growth hormone), BioLon(TM) (sodium hyaluronate), Bio-Hep-B(TM) (hepatitis B vaccine), and Silkis(R) (vitamin D derivative). BTG's news releases and other information are available on the Company's website at www.btgc.com.

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.