Thursday, Mar 27, 2003
South San Francisco, Calif., East Hanover, N.J., and Houston -- March 27, 2003 --Genentech, Inc. (NYSE: DNA), Novartis Pharmaceuticals (NYSE: NVS) and Tanox, Inc. (Nasdaq: TNOX) today announced that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee (PADAC) will review the companies' Biologics License Application (BLA) for Xolair (Omalizumab) for the treatment of moderate-to-severe allergic asthma in adolescents and adults on May 15, 2003.
"Asthma remains an area of significant unmet medical need, and the FDA Advisory Committee review is an important step toward our goal of providing a novel biologic treatment for people struggling to control allergic asthma. This is an important step for Xolair and a significant event for the field of anti-IgE research and development," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs.
"We believe that medications based on anti-IgE technology might be the most promising advance in the treatment of allergic asthma since the very first efforts to control allergic disorders. If approved, Xolair would be the first IgE blocker and the first biologic therapy for the treatment of allergic asthma," said Paulo Costa, President and Chief Executive Officer, Novartis Pharmaceuticals Corporation.
Genentech and Novartis submitted an amendment to the Xolair BLA in December 2002. Xolair is a humanized therapeutic antibody to IgE in development under an agreement among Novartis Pharma AG, Genentech and Tanox, Inc. In allergic patients, the binding of IgE antibodies and allergens to inflammatory cells called mast cells triggers release of inflammatory mediators, such as histamines and leukotrienes, which can lead to the symptoms and inflammation of allergic asthma. Xolair is designed to block IgE from attaching to mast cells and work early in the allergic inflammatory process.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72,900 people and operate in over 140 countries around the world. For further information please consult http://www.pharma.us.novartis.com or http://www.novartis.com.
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. Xolair, Tanox's most advanced product in development, is an anti-immunoglobulin E, or anti-IgE, antibody whose therapeutic effect has been studied in clinical trials in patients suffering from allergic asthma. Xolair is being developed under an agreement among Tanox, Novartis Pharma AG and Genentech. In June 2002, Xolair received marketing approval in Australia for treating adults and adolescents with moderate allergic asthma. This release and other information about Tanox, Inc. can be found on the World Wide Web at http://www.tanox.com.
This release contains certain forward-looking statements relating to the potential benefit of Xolair as a biologic therapy for the treatment of allergic asthma. Those statements reflect the current views of Genentech, Novartis and Tanox (the Companies) with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors, including but not limited to the failure to obtain regulatory approval for Xolair, could cause the actual results, performance or achievements of the Companies to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements.