HOUSTON, Oct. 27 /PRNewswire-FirstCall/ -- The European Commission has approved Xolair(R) (omalizumab) for the treatment of severe allergic asthma in all 25 European Union member states. Xolair, developed under an agreement between Tanox, Inc. , Genentech, Inc. and Novartis Pharma AG, is expected to be available in initial EU markets within the next few weeks.
Xolair is the first humanized therapeutic antibody to be approved for the treatment of allergic asthma, and offers a unique therapeutic approach by blocking the action of IgE, an underlying cause of inflammation and resulting symptoms in allergic disease.
“Xolair has the potential to transform the lives of patients who suffer from severe allergic asthma by reducing the number of asthma attacks they experience,” said Nancy Chang, Ph.D., Tanox president and chief executive officer.
“Since Xolair’s approval in the U.S., we’ve seen how patients have benefited from its use. It’s extremely rewarding to know that asthma sufferers in Europe will soon have access to the therapy.”
The Food and Drug Administration approved Xolair in June 2003 for subcutaneous use for the treatment of adults and adolescents (12 years of age and above) with moderate-to-severe persistent allergic asthma. It is prescribed to patients who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
Xolair is administered by subcutaneous injection every two or four weeks. Clinical studies have shown that Xolair significantly reduced the rate of asthma exacerbations (attacks). As of Sept. 30, 2005, Xolair had been prescribed to more than 50,000 patients. This first-in-class therapy is also approved in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela.
In Europe, Xolair is licensed as add-on therapy to improve asthma control in adults and adolescents (ages 12 and above) with severe persistent allergic asthma, who, despite receiving high-dose inhaled corticosteroids and a long- acting inhaled beta2-agonist on a daily basis, had:
* A positive skin test or in vitro reactivity to a perennial aeroallergen * Reduced lung function (FEV1 <80%) * Frequent daytime symptoms or night-time awakenings * Multiple documented severe asthma exacerbations
Xolair treatment should only be considered for patients with IgE-mediated asthma.
The use of Xolair is supported by a comprehensive program of more than 30 clinical trials involving a total of approximately 5,500 patients. These trials demonstrated Xolair’s efficacy in controlling symptoms, reducing asthma exacerbations and the need for emergency medical treatment, and improving quality of life, even in patients with severe allergic asthma that was uncontrolled by existing medication.
In Europe, Xolair will be exclusively marketed by Novartis. Xolair is co- marketed in the U.S. by Genentech and Novartis. Tanox receives royalties on sales of Xolair and receives a share of Novartis’ net profits on sales in the U.S.
Safety Information
The most serious adverse events occurring in clinical studies with Xolair were malignancies (0.5% in Xolair vs. 0.2% in placebo) and anaphylaxis (<0.1% in Xolair). The majority of patients were observed for less than one year. The impact of longer exposure to Xolair or use in patients at higher risk for malignancy is unknown. Anaphylaxis has occurred within 2 hours of the first or subsequent administration of Xolair in <0.1% of patients without other identifiable allergic triggers. Anaphylactic reactions were rare but temporally associated with Xolair administration. Patients should be observed after injection of Xolair, and medications for the treatment of severe hypersensitivity reactions, including anaphylaxis, should be available. If a severe hypersensitivity reaction to Xolair occurs, therapy should be discontinued.
In clinical trials, the most frequent adverse events included injection site reaction (45%), viral infections (23%), upper respiratory tract infections (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in Xolair-treated patients and control patients.
For a copy of full prescribing information for Xolair, visit http://www.xolair.com .
About Tanox, Inc.
Tanox is a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology. The company develops innovative therapeutic agents for the treatment of immune- mediated diseases, inflammation, infectious disease and cancer. Tanox’s lead investigational therapy, TNX-355, is a humanized, anti-CD4 monoclonal antibody to treat HIV and AIDS. TNX-355 has received Fast Track Status from the U.S. Food and Drug Administration and is currently in Phase 2 clinical testing. Tanox’s first-approved drug, Xolair(R) (omalizumab), is the first anti- immunoglobulin E (anti-IgE) antibody to be brought to market. Xolair was developed in collaboration with Genentech, Inc. and Novartis Pharma AG and approved for marketing in the United States for adult and adolescent patients with moderate-to-severe, confirmed allergic asthma. Tanox is based in Houston, Texas and maintains a manufacturing facility in San Diego, California. Additional corporate information is available at http://www.tanox.com .
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20050207/TNOXLOGOPRN Photo Desk photodesk@prnewswire.comTanox, Inc.
CONTACT: Steve Sievert of Tanox, Inc., +1-713-578-4211, orssievert@tanox.com
