Description Xolair® (Omalizumab) is a recombinant humanized monoclonal antibody, which specifically targets the antibody IgE, an underlying component of allergic asthma. In some patients, when allergens enter the body, IgE antibodies are produced and circulate in the blood. IgE circulating in the blood binds to mast cells, which contain inflammatory chemicals (histamine, leukotrienes, others). Upon re-exposure to an allergen, IgE on the mast cell cross-links and triggers mast cells to release these chemicals. This chemical release triggers the inflammation, bronchial constriction and coughing associated with allergic asthma. Xolair is designed to bind to the circulating IgE antibodies in the blood, decreasing the amount of IgE antibodies available to bind to mast cells.

Development Status A Phase III clinical trial evaluating Xolair for pediatric asthma completed enrollment in Q4 2006. This trial enrolled patients 6-11 years of age with moderate-to-severe allergic asthma.

Xolair is being developed in collaboration with Novartis Pharma AG.

Approved Uses

• In June 2003, the U.S. Food and Drug Administration (FDA) approved Xolair for the treatment of adults and adolescents (12 years of age and above) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Read more about Xolair's approved use.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

November 2007