FDA Approves Xolair (omalizumab) for Moderate-to-Severe Asthma
South San Francisco, Calif., East Hanover, NJ, and Houston, TX - June 20, 2003 - Genentech, Inc. (NYSE: DNA), Novartis Pharmaceuticals Corporation, an affiliate of Novartis AG (NYSE: NVS), and Tanox, Inc. (NASDAQ: TNOX) announced today that the novel IgE-blocker Xolair® (Omalizumab) For Subcutaneous Use has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe persistent asthma in adults and adolescents. Xolair is the first humanized therapeutic antibody for the treatment of asthma and the first approved therapy designed to target the antibody IgE, a key underlying cause of the symptoms of asthma that has an allergic component. Xolair is expected to be available by prescription beginning July 2003.
Xolair is indicated for 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. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.
"Genentech has a long history of innovating first-in-class biologics and pioneering unique approaches to disease management," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "Xolair is a significant advance in the evolution of asthma therapy and its approval is a milestone event in bringing biologic therapies to new markets and meeting an unmet need for patients with asthma mediated by IgE. The approval today is a testament to the persistence and teamwork of Genentech, Novartis and Tanox employees, the Xolair clinical investigators and their staffs and, most importantly, the patients who participated in our clinical research."
"The social and economic burdens associated with moderate-to-severe persistent asthma are enormous, and Xolair represents an important advance in the management of this debilitating condition," said Paulo Costa, president and chief executive officer, Novartis Pharmaceuticals Corporation. "We and our collaborators are proud to bring this innovative therapy to asthma patients in need of new treatment options."
According to the National Institutes of Health, direct and indirect financial costs for all forms of asthma totaled $14 billion in 1998. In addition, asthma leads to at least two million emergency room visits and more than 5,000 deaths in the United States each year, according to the Center for Disease Control and Prevention's National Center for Health Statistics.
"We are gratified to see this novel idea for treating asthma by binding IgE finally become a reality for the many people who suffer from this disease," said Nancy T. Chang, president and chief executive officer of Tanox, Inc. "Xolair's approval represents a significant milestone in the development of Tanox as a biopharmaceutical company."
Xolair is being jointly developed under an agreement among Novartis Pharma AG, Genentech, Inc. and Tanox, Inc., and will be co-marketed in the United States by Genentech and Novartis Pharmaceuticals Corporation. In addition to approval in the United States, Xolair has also received marketing license from health authorities in Australia.
Clinical Study Results
The companies' data submission to the FDA included two 52-week pivotal Phase III clinical trials with 1,071 asthma patients, 12 to 76 years of age, as well as data from several supportive safety and efficacy studies, including the 1,899-patient ALTO safety study. The pivotal trials were designed to study a reduction in asthma exacerbations. The co-primary endpoint of each study was the number of asthma exacerbations per patient during the stable-steroid phase and the steroid-reduction phase. Patients were randomized to receive subcutaneous Xolair or placebo every two or four weeks. Doses were determined based on patients' body weight and IgE level. Inhaled corticosteroid doses were kept stable over the initial 16 weeks of treatment (stable-steroid phase) and tapered during a further 12-week treatment period (steroid-reduction phase).
When used as an add-on therapy to inhaled corticosteroids, in both pivotal clinical trials, Xolair reduced mean asthma exacerbations ("asthma attacks") per patient by 33%-75% during the stable-steroid phase and 33%-50% during the steroid-reduction phase. Reduction in asthma exacerbations was confirmed by improvements in other measures of asthma control including symptom scores such as nocturnal awakenings and daytime asthma symptoms.
Xolair has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus. Systemic or inhaled corticosteriods should not be abruptly discontinued upon initiation of Xolair therapy. Decreases in corticosteroids should be performed only under the direct supervision of a physician and may need to be reduced gradually.
The most serious adverse reactions occurring in clinical studies with Xolair are malignancies (0.5% in Xolair vs. 0.2% in placebo) and anaphylaxis (<0.1% in Xolair). The difference in malignancy between the Xolair and placebo arms was not statistically significant. Xolair treatment is generally well tolerated. The most frequent adverse events included injection site reactions (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.
About IgE and the Allergic Cascade
Asthma with an allergic component is a chronic inflammatory disorder of the airways, in which exposure to an aeroallergen triggers an allergic cascade that may result in airway inflammation and obstruction. 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 the inflammatory chemicals (histamine, leukotrienes, others). Upon 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 asthma. Xolair is designed to bind to the circulating IgE antibodies in the blood, decreasing the amount of IgE antibodies available to bind mast cells. With Xolair, fewer IgE antibodies can bind to mast cells, making IgE cross-linking on mast cells less likely and therefore inhibiting the mast cell's release of those chemicals that can lead to the symptoms of asthma.
Information about Xolair, including prescribing information and comprehensive support services, will be available through a single toll-free number, 1-866-4-XOLAIR. Services for Xolair include patient and healthcare provider support and reimbursement support. IgE and allergic asthma information is currently available on www.clearbreathing.com and a brand website, www.Xolair.com, will be introduced with information for patients and physicians.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 11 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional information about the company, please visit http://www.gene.com.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D.; Headquartered in Basel, Switzerland, Novartis Group companies employ about 77,200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Tanox, Inc. is a biopharmaceutical company with demonstrated expertise in monoclonal antibody technology. The Company is engaged in the discovery and development of therapeutic monoclonal antibodies designed to address significant unmet medical needs in the areas of asthma, allergy, inflammation and other diseases affecting the human immune system. This release and other information about Tanox, Inc. can be found on the World Wide Web at http://www.tanox.com.
This release contains certain forward-looking statements relating to the potential benefit of Xolair® as a biologic therapy for the treatment of asthma. Those statements reflect the current views of Genentech, Novartis and Tanox (the Companies) with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors, including but not limited to, the rate of adoption by the marketplace and the use of competitive products, could cause the actual results, performance or achievements of the Companies to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements.
Posted: June 2003
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