Novartis, a world leader in healthcare with core businesses in pharmaceuticals, has welcomed a 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 marketing approval anywhere in the world so far for Xolair.

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).

Thomas Ebeling, CEO of Novartis Pharma AG, said: "We are delighted by this approval, which means that asthma patients are a step closer to experiencing the benefits of this new treatment. Xolair seems to offer a unique method to enhance the control of their disease by targeting a root cause of allergic asthma."

Xolair - which was developed under an agreement between Novartis Pharma AG, Genentech, Inc. and Tanox, Inc. - is a monoclonal antibody and the first agent to specifically target IgE. It works by binding to circulating IgE and preventing it from attaching to mast cells. Without IgE bound 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.

Meanwhile, submissions for the approval of Xolair are proceeding in a number of other important markets. In the US, Genentech and Novartis are planning to submit an amendment to the Biologics License Application for Xolair to the Food and Drug Administration in the fourth quarter of 2002. The content of this amendment will address requests for additional information made by the FDA in a Complete Response letter issued in July 2001, and the companies expect that data from ongoing trials will satisfy those requests.