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NORTH AMERICAN BIOLOGICALS ACQUIRES RIGHTS TO ABBOTT’s HIVIG

Executive Summary

NORTH AMERICAN BIOLOGICALS ACQUIRES RIGHTS TO ABBOTT's HIVIG, an immunoglobulin product under study to prevent the transmission of AIDS from HIV-positive pregnant women to their children. Under an agreement announced Oct. 8, North American Biologicals, Inc. (NABI) will also license Abbott's hepatitis B immune globulin, H- BIG, in exchange for 2 mil. shares of common stock worth about $8 mil. at current market rates. Abbott will receive royalties on product sales. "NABI's right to acquire HIVIG from Abbott is subject to Abbott's receiving satisfactory immunity from civil lawsuits for clinical and commercial uses of HIVIG," NABI noted. Earlier this year, Abbott backed out of an AIDS Clinical Trials Group study of HIVIG in pregnant women (protocol ACTG 185) citing product liability concerns ("The Pink Sheet" July 13, T&G-9). When Abbott feels that its liability concerns have been addressed, NABI will have exclusive rights to Abbott's clinical development work to date. In the meantime, NABI is bidding to use its own HIV immunoglobulin product in the ACTG 185 trial. The National Heart Lung & Blood Institute put out a request for proposals seeking a new HIVIG supplier in July. It appears that NABI will have to wait at least until next year to exercise its option to acquire Abbott's HIVIG. Abbott believes its concerns can only be addressed by legislation similar to that introduced by Rep. Stark (D-Calif.) earlier this year ("The Pink Sheet" Aug. 24, T&G-8). Stark's bill (HR 5893) would have established an AIDS vaccine injury compensation fund, but the bill was not acted upon by the House. Abbott believes that even if it licenses HIVIG to NABI it could be held liable. H-BIG will provide NABI with its first entry into the human pharmaceutical market. H-BIG "currently has sales of approximately $5 mil. per year," NABI said. The product is marketed worldwide, although NABI will initially take over marketing only in the U.S., Canada, Mexico and Europe. Abbott will continue marketing H-BIG for NABI in Latin America and the Pacific. H-BIG "has been marketed by Abbott for prophylactic use for adults and children exposed to the [hepatitis B] virus and for infants born to hepatitis B-positive mothers," NABI said. "NABI believes that sales [of H-BIG] can be significantly increased through additional medical indications and enhanced international marketing efforts," the company said. Since its founding in 1969, Miami-based North American Biologicals has been a supplier of source plasma to various blood products manufacturers. The company has supplied Abbott with plasma for use in manufacturing H-BIG and for some of its diagnostics. NABI's sales in 1991 were $68 mil.

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