Bio-Technology General is entitled to a compulsory license for hepatitis B vaccine.

ISELIN, N.J.--(BUSINESS WIRE)--Sept. 21, 1995--Bio-Technology General Corp. (NASDAQ:BTGC) today announced that the Israeli Registrar of Patents has ruled that Bio-Technology General (Israel), a wholly owned subsidiary of Bio-Technology General Corp., is entitled to a compulsory license to Biogen's Israeli patent No. 59007 which relates to genetically engineered hepatitis B vaccine. The Registrar's decision follows proceedings which began in January 1992 when BTG filed its application for a compulsory license.

Unless the determination is stayed or overturned on appeal, the granting of the compulsory license will allow BTG to produce and market its third generation mammalian cell-based hepatitis B vaccine in Israel and should also enable the marketing of the vaccine in countries in which neither Biogen nor others have been granted a valid blocking patent. Under the terms of the Registrar's decision, BTG and Biogen have been instructed to provide the Registrar with agreed terms within thirty days from the date of the decision, including royalties to be paid by BTG to Biogen. After this thirty day period, the Registrar will finalize conditions to the two companies.

David Haselkorn, Chief Operating Officer of Bio-Technology General Corp., stated: "The Company sees this license as a major milestone in the development of its hepatitis B vaccine. It will allow BTG to complete the necessary clinical development and to make the regulatory filings required for approval to market the vaccine in countries in which there is no valid blocking patent. These markets account for an incidence of more than 200 million cases of hepatitis B infection with a total market size in excess of $200 million annually. Given the growing trend towards government mandated immunization of newborns in countries where hepatitis B is endemic, the demand for a competitive and effective hepatitis B vaccine is likely to continue to expand."

Bio-Technology General Corp.'s hepatitis B vaccine differs from currently available recombinant hepatitis B vaccines manufactured by SmithKline Beecham and Merck in that it incorporates the S, pre-S1 and pre-S2 surface antigens of the virus.

In other news, BTG announced that BioLon has been approved for marketing in Italy, Colombia and Singapore and that during this month, BTG's human growth hormone will be launched in two additional European countries.

BTG's request for an expedited hearing on its appeal of the preliminary injunction granted Genentech with respect to Bio-Tropin was approved by the United States Court of Appeals for the Federal Circuit and is expected to be heard December 1995.

Bio-Technology General Corp. develops, manufactures and markets genetically engineered and other products for human health care.

CONTACT: Bio-Technology General Corp., Iselin

Leah Berkovits, 908/632-8800

or

Strategic Growth International, New York

Investor Relations:

Don Weinberger, 516/829-7111