SMITHKLINE BEECHAM'S ENERGIX-B COSTS OVER $ 20 LESS

SMITHKLINE BEECHAM'S ENERGIX-B COSTS OVER $ 20 LESS per person than Merck Sharp & Dohme's recombinant DNA vaccine Recombivax-HB, SmithKline Beecham declared in a Sept. 8 press release. "The average wholesale price (AWP) of Energix-B will be $ 147.60 for three doses; the AWP for the Merck Sharp & Dohme recombinant DNA vaccine is $ 170.51 for three doses," the release says. SmithKline Beecham introduced its recently approved recombinant hepatitis B vaccine at a Sept. 8 media briefing in New York City. Energix-B, approved by FDA on Aug. 28, is the second recombinant hepatitis B vaccine to be cleared for marketing in the U.S. ("The Pink Sheet" Sept. 4, "In Brief"). The Energix-B product license application had been pending at the agency since late 1987. The vaccine was launched immediately following approval and will be distributed in the U.S. by Smith Kline & French Labs, the firm said. The company estimated that the current U.S. market for hepatitis B vaccines is about $ 85 mil. Besides cost savings, SmithKline Beecham maintained that the vaccine has other advantages over Recombivax-HB. "In addition to the standard six-month dosing schedule, Energix-B has a new two-month schedule indicated for specific populations such as individuals recently exposed to the hepatitis B virus (that is post-needlestick exposure), family members of hepatitis B patients, babies born of infected mothers, and certain travelers," the release says. Energix-B, SmithKline Beecham noted, has double the dose of its active ingredient than does Recombivax HB. "Each dose of Energix-B contains 20 micrograms of the ingredient that stimulates the immune system to form antibodies against the hepatitis B virus." SmithKline Beecham said that "with the six-month standard dosing schedule, 96% of individuals develop protective antibodies after the third dose is administered at six months." Furthermore, the company added, "with the new 0-1-2 month schedule, 99% of individuals develop protective antibodies one month after the third dose is administered at two months." Under a 1988 licensing agreement, SmithKine Beecham provides Biogen with royalties from sales of Energix-B ("The Pink Sheet" April 11, 1988, T&G-4). The agreement gives SmithKline the right to make recombinant hepatitis B antigens for use in vaccine and diagnostic products. SmithKline also received the right to manufacture and sell recombinant hepatitis B vaccine products in the U.S. and other countries except Japan.