Bio-Technology General Corp. Announces Initial Hepatitis-B Vaccine Approval
Business Editors
ISELIN, N.J.--(BUSINESS WIRE)--February 14, 2000--Bio-Technology General Corp. (NASDAQ:BTGC) today announced that it has received approval to market its genetically engineered hepatitis B vaccine, Bio-Hep-B(tm), from the Israel Ministry of Health. This product, the first recombinant hepatitis B vaccine to be approved anywhere in the world that integrates the S, pre-S1, and pre-S2 surface proteins of the virus, enables successful immunization with significantly lower doses of vaccine than other recombinant hepatitis B vaccines. Bio-Hep-B represents the most advanced hepatitis B vaccine in terms of its efficacy profile.
BTG's Bio-Hep-B has been tested in a broad-based clinical research program in several thousand individuals, including adults, children, neonates, individuals at high-risk for infection, immunosuppressed individuals, and non-responders to other hepatitis B vaccines. In all of BTG's studies, Bio-Hep-B elicited a quicker response and higher levels of circulating antibodies to the hepatitis B virus than other recombinant hepatitis B vaccines. This suggests the potential, when utilizing Bio-Hep-B, for faster and better protection against the virus.
"We are enormously pleased to have received our first approval for Bio-Hep-B," stated Sim Fass, Chairman and CEO of Bio-Technology General, "and we intend to launch it in Israel at the earliest opportunity. Of much greater commercial significance, however, is that the Israeli approval, together with a Certificate of Free Sale, allows us and our licensees, Swiss Serum, SciGen, and Afrovax to initiate the registration process for Bio-Hep-B in many countries around the world. In addition, in some territories, the Israeli approval and Certificate of Free Sale are themselves sufficient for us to offer Bio-Hep-B for sale immediately. We believe Bio-Hep-B will have wide appeal in many countries where hepatitis B is endemic. We expect it to prove to be a superior alternative to both plasma derived vaccines and recombinant vaccines, such as Recombivax HB(R) and Engerix-B(R), which incorporate only the S antigen. We intend, together with our partners, to actively compete in the $1 billion worldwide market for hepatitis B vaccines."
Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human health care. The Company'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. |
