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Executive Summary

ALPHA THERAPEUTICS' VENOGLOBULIN-S SET FOR FEBRUARY LAUNCH following approval of the "virally inactivated" I.V. immunoglobulin on Nov. 13. Venoglobulin-S 5% solution immune globulin intravenous (human), solvent detergent-treated preparation was approved for the I.V. maintenance treatment of patients with primary immunodeficiency syndromes and acute and chronic idiopathic thrombocytopenic purpura (ITP). Pricing will be announced when the product is available. Venoglobulin-S will be provided as a ready-to-use preservative- free liquid in 50 mL, 100 mL and 200 mL sizes. Venoglobulin-S is the "first virally inactivated, liquid intravenous immunoglobulin G product" approved in the U.S. Alpha Therapeutics said. The antibody product supplies a "broad spectrum of opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic and mycoplasma antigens. These antibodies have retained full biological function for the prevention or attenuation of a wide variety of infectious diseases," the company said. Approved labeling states that Venoglobulin-S contains "all IgG antibody activities present in the donor population. The distribution of IgG subclasses corresponds to that of normal human plasma." The mean half-life of total IgG for Venoglobulin-S is 33.5 days, labeling states. Venoglobulin-S for patients with primary immunodeficiency syndromes is "especially useful" for those who "require an immediate and substantial increase in intravascular immunoglobulin levels, in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated," labeling states. In clinical trials for idiopathic thrombocytopenic purpura, Venoglobulin-S showed efficacy in 29 of 38 patients overall, or 76%, labeling states. "Platelet counts greater than 100,000/mm were observed within seven days of the initial induction infusions in 64% (nine of 14) of juvenile ITP patients, 80% (four of five) of adult patients with acute ITP, 57% (four of seven) of juvenile chronic ITP patients and 100% (12 of 12) of adult chronic ITP patients." Labeling notes that the process used to produce Venoglobulin-S "inactivates and/or partitions up to 13 cumulative logs" of HIV-1. Additional treatment with solvent-detergent removes "greater than 10 logs of HIV-1 and greater than six logs of HIV-2." Alpha Therapeutics has marketed Venoglobulin-I IV-IG human sterile, nonpyrogenic lyophilized powder in the U.S. since 1988. Alpha Therapeutics and its parent, Green Cross Corp. (Osaka), have sold over 3 mil. infusions of Venoglobulin-I and more than 10 mil. grams worth of the biologic have been used, the company said. Venoglobulin-I was first approved in Japan in 1980. Los Angeles-based Alpha Therapeutics Corp.'s other products include: Fluosol oxygen transport fluid used to prevent myocardial ischemia during angioplasty (approved in late 1989); Alphanine (Factor IX) purified coagulation factor, which was launched in February 1991 after a Dec. 31, 1990 approval; human albumin; plasma protein fraction; antihemophilic factor; and factor IX complex.

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