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MEAD JOHNSON's HAEMOPHILUS INFLUENZAE B VACCINE IS BEING TARGETED

Executive Summary

MEAD JOHNSON's HAEMOPHILUS INFLUENZAE B VACCINE IS BEING TARGETED directly to physicians, the company told "The Pink Sheet." Mead Johnson noted that it plans to market 70% of the vaccine, B-Capsa I, directly to physicians and the remaining 30% to whslrs. The price to both physicians and whslrs. is between $6.50 and $7.00 for a single 0.5 ml dose. In a press release announcing the April 12 approval by FDA, Mead Johnson noted that B-Capsa I "is manufactured by Praxis Biologics and will be distributed exclusively by the Mead Johnson Nutritional Division." In December, Mead Johnson announced that it had entered a distribution agreement with Rochester, N.Y.-based Praxis Biologics to be "the exclusive North American distributor for certain products developed and manufactured by Praxis" ("The Pink Sheet" Jan. 7, T&G-2). Approved after approximately two years of review, B-Capsa I is the first vaccine marketed by Mead Johnson and the first product developed by Praxis to be approved. Mead Johnson noted it "plans to make available nearly two million doses of the new vaccine immediately." The vaccine "is indicated for immunization of children 24 months to six years of age against diseases caused by Haemophilus influenzae b . . . and may be given to children 18-23 months of age known to be at high risk of systemic Hib disease, e.g., children who attend day care," the approved package insert states. According to the package insert, U.S. studies "indicate that a child's cumulative risk of developing a systemic Hib disease at some time during the first five years of life is about one in 200." In these U.S. studies, the insert continues, "about 35-40% of systemic Hib disease has occurred in children 18 months of age or older." The insert states that B -- Capsa I "will not protect children younger than 18 months of age and will not protect against Haemophilus influenza other than type b or other microorganisms that cause meningitis or septic disease." The labeling also notes that studies are ongoing "to determine the need and timing for revaccination, particularly for children vaccinated at 18-23 months of age." In addition, Praxis Biologics has agreed to conduct a post-licensing surveillance study on adverse reactions associated with the vaccine.
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