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Tanox, Inc. Announces Xolair (Omalizumab) Marketing Approval in Australia HOUSTON, TX -- June 19, 2002 -- Tanox announced the decision by the Therapeutic Goods Administration (TGA) in Australia to approve the new anti-IgE therapy Xolair® (omalizumab) for treating adults and adolescents with moderate allergic asthma. This represents the first ever marketing approval anywhere for Xolair. Xolair is being developed under an agreement among Tanox, Inc., Novartis Pharma AG, and Genentech, Inc. "We are very pleased with the approval of Xolair in Australia and look forward to helping the many patients with allergic asthma," said Nancy T. Chang, CEO and founder of Tanox, Inc. Novartis has indicated that the decision comes after the Australian Drug Evaluation Committee agreed that Xolair should be indicated for the management of adult and adolescent patients with moderate allergic asthma who are already being treated with inhaled steroids and have raised levels of serum immunoglobulin E (IgE). Xolair is a humanized monoclonal antibody that works by binding to circulating IgE and preventing it from attaching to mast cells. Without the binding of IgE to mast cells, the presence of an allergen will not cause the release of chemical mediators like histamine and leukotrienes, which lead to the symptoms and inflammation of allergic asthma. Xolair is administered every two to four weeks subcutaneously (i.e. by injection under the skin), at a dose depending on the patient's body weight and IgE level. In June 2000, Novartis and Genentech filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) and a submission for marketing approval with health authorities in the EU, Switzerland, Australia, and New Zealand. Following receipt of a Complete Response Letter from the FDA in July 2001, Genentech and Novartis have indicated that they are planning to submit an amendment to the BLA in the fourth quarter of 2002, for allergic asthma in adults and adolescents. The content of this amendment will also address requests for additional information made by the FDA in the Complete Response Letter, and those companies expect that data from ongoing trials will satisfy those requests. About Tanox Tanox, Inc. is a biopharmaceutical company with demonstrated expertise in monoclonal antibody technology. The Company is engaged in the discovery and development of therapeutic monoclonal antibodies designed to address significant unmet medical needs in the areas of asthma, allergy, inflammation and other diseases affecting the human immune system. Statements in this press release about Xolair and its prospects for development and commercialization, other than statements of historical facts, are forward-looking statements and are subject to a number of uncertainties that may cause actual events or results to differ materially from those suggested in the forward-looking statements. Factors that could affect actual events or results include risks associated with obtaining regulatory approval for and market acceptance of Xolair, performance by the Company's present and future collaboration partners, competition and technological change, and existing and future government regulations. Other risks that may affect Tanox include the unpredictability of decisions by the FDA and other regulatory agencies, including decisions regarding whether sufficient data and compliance with other requirements exist to support product licensure. There can be no certainty that Xolair will be approved in any other market. This release and other information about Tanox, Inc. can be found on the World Wide Web at http://www.tanox.com . SOURCE: Tanox, Inc. E-mail this page to a friend or colleague! To print, use this version