Clinical Results Suggest Increased Standards of Purity for Pharmaceutical and Biological Products

05-Oct-2000

King of Prussia, PA, October 4, 2000 - Aventis Behring L.L.C. announced today the successful results of its large, pivotal Phase I clinical trial for Recombumin®20%. The trial was designed to assess the tolerability of Recombumin®20% as a stabilizing component in pharmaceutical and biological products, such as vaccines, recombinant therapies and coatings for medical devices. Recombumin 20% is a recombinant, or completely biosynthetic, human albumin product. The manufacturing process begins with fermentation in yeast, yielding a product that is free of human or animal-derived material with a level of purity that is unparalleled in biological products. Manufacturers of biological products can use Recombumin®20% as a stabilizing agent for new therapies in development or by replacing less optimal stabilizers in their existing products. Delta Biotechnology Ltd., a wholly owned subsidiary of Aventis Behring, is already producing Recombumin 20% in small amounts. "We believe Recombumin®20% can raise the standard of purity and safety in important therapies already developed to prevent and treat diseases around the world. Because it is a recombinant product derived from fermentation in yeast, there is not even a theoretical risk that it will transmit any known, unknown or newly emerging infectious agents," stated Werner Merkle, Vice President and General Manager of Delta Biotechnology Ltd. "Recombumin®20% symbolizes the future of Aventis Behring as we continue to combine state-of-the-art technology with our rich heritage in plasma therapy." Between November, 1999 and June, 2000, five-hundred subjects were included in this double-blind, randomized, parallel-group, dose-escalating study comparing Recombumin®20% to human serum albumin 20%. The trial was conducted in Sweden under a United States food and Drug Administration Investigational New Drug Application (IND). The volunteers received intramuscular administrations, once a week for five consecutive weeks, of either Recombumin®20% or human serum albumin (HSA) 20% at dose levels of 5 mg (100 subjects), 15 mg (100 subjects) or 65 mg (300 subjects). The results of the study demonstrated the safety and good tolerability of Recombumin®20% up to a dose of 65 mg. Since the expected highest single dose is 15 mg, the good tolerability of the 65 mg dose provides an excellent safety margin. The overall incidence of adverse events, (e.g. those referring to allergic reactions), was low and comparable between the Recombumin®20% and the hu

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