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| |  Europe Approves Helixate Nexgen Recombinant Product For Hemophilia A KING OF PRUSSIA, PA -- August 10, 2000 -- Aventis Behring L.L.C. announced that the European Commission has approved Helixate® NexGen, an advanced recombinant product for the treatment of Hemophilia A. The new formulation provides tremendous benefits for patients with Hemophilia A, including significant reduction in the risk of viral transmission and an increased convenience combined with demonstrated efficacy. The European Commission's centralized approval procedure results in a single marketing authorization valid in all fifteen-member states. "Patients with hemophilia want to spend more time enjoying life and less time infusing therapy," says Gail Schulze, Senior Executive Vice President, Aventis Behring. "Aventis Behring's Helixate NexGen has a faster infusion rate and an enhanced safety profile which provides hemophilia patients with the time and the peace of mind to be a part of today's active lifestyle." Helixate NexGen is one of the first factor VIII products formulated without human albumin in the final formulation and has added an additional viral inactivation step known as solvent detergent treatment. Helixate NexGen can be reconstituted with less diluent than the first generation Helixate; thereby reducing infusion volume by 75 percent, reducing the total infusion time and improving patient convenience. Market introduction of Helixate NexGen is planned for the third quarter. In a study involving 71 patients who infused more than 22 million units, the safety and efficacy of Helixate NexGen in the prevention of bleeding episodes associated with hemophilia A was established. Study results demonstrate that 93.5 percent of bleeding episodes were treated successfully with one or two infusions. Additionally, 15 of these study participants received Helixate NexGen on 22 occasions to prevent bleeding during surgery. Hemostasis was good or excellent in all cases. Helixate NexGen contains the original protein found in Helixate and has demonstrated Helixate NexGen bioequivalency. Adverse reactions are generally rare, mild and transient and primarily include rash, local reactions at the injection site, and dizziness. In addition, clinical studies have shown no increased inhibitor development in previously untreated patients compared to plasma-derived factor VIII. Related Link: Aventis Behring L.L.C..
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