More than forty million in the US population are afflicted with IgE-mediated allergic diseases such as allergic asthma, rhinitis, food allergy, and anaphylactic shock. Twenty million are afflicted with allergic asthma in the US alone.
Revenues generated by prescription small molecule drugs in treating allergic asthma and rhinitis have exceeded twenty billion USD. The annual growth of the market is more than 10%. Xolair is the only approved anti-asthma large molecule drug in the biological category. This drug is in the form of a monoclonal antibody produced by Genentech. In 2006, annual sales of Xolair exceeded 320 million. The medical reimbursement cost restricted its distribution to moderate to severe asthmatic patients, and the side effect of anaphylaxis has caused an FDA black-box warning to this group of prescribed users.
The next generation of IgE therapeutics in the biological category developed by IgE Therapeutics targets the upstream to lower levels of IgE levels. The drugs may elicit protective cellular and humoral immune responses in the recipients with lower IgE levels. Due to the technological advantage and the lower cost, the products may serve all patients afflicted with allergic asthma and rhinitis.