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 In the fourth quarter of 2008, we submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for children 6 to <12 years old 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 on inhaled corticosteroids.

A Phase III clinical trial is ongoing evaluating Xolair in adults and adolescents with moderate-to-severe persistent asthma who are inadequately controlled with high-dose inhaled corticosteroids and long-acting beta-agonists. A Phase II clinical trial evaluating Xolair in chronic idiopathic urticaria is ongoing.

Xolair is being developed in collaboration with Novartis Pharma AG.

Approved Uses

• In June 2003, the 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.

BOXED WARNINGS and Important Safety Information Xolair should always be injected in a doctor's office. Patients should read the Medication Guide before starting Xolair treatment and before each and every treatment.

A severe allergic reaction called anaphylaxis has happened in some patient after they received Xolair. Anaphylaxis is a life-threatening condition. Patients should seek emergency medical treatment right away if symptoms occur. Signs and symptoms of anaphylaxis include:

• Wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
• Flushing, itching, hives, or feeling warm
• Swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing.

In clinical studies 0.5% of patients receiving XOLAIR developed cancer, compared to 0.2% of patients receiving placebo injections.

In clinical studies, the most common side effects in patients receiving Xolair included injection-site reactions (45%), viral infections (23%), upper respiratory tract infection (20%), sinus infection (16%), headache (15%), and sore throat (11%).

For Xolair full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.xolair.com.

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

August 2009