Wednesday, Dec 18, 2002
South San Francisco, Calif. and East Hanover, N.J. -- December 18, 2002 --Genentech (NYSE: DNA) and Novartis Pharmaceuticals Corporation (NYSE: NVS) today announced they have submitted to the U.S. Food and Drug Administration (FDA) an amendment to the Biologics License Application (BLA) for Xolair™ (Omalizumab), a recombinant humanized monoclonal antibody under evaluation for the treatment of adult and adolescent moderate-to-severe allergic asthma.
“We are pleased to have reached the next step in Xolair development and, with our partner Novartis, remain committed to and confident about Xolair as a potential treatment for patients living with moderate to severe allergic asthma,” said Susan D. Hellmann, M.D., M.P.H., Genentech’s executive vice president, Development and Product Operations, and chief medical officer. “Asthma remains an area of significant unmet medical need, and we have developed a completely novel approach to treat this chronic illness with a biologic therapy.”
"Submitting this amended BLA for Xolair is an important step toward our goal of providing novel biologic treatment options for people struggling to control their asthma," said Thomas Ebeling, CEO of Novartis Pharma AG. “Novartis and Genentech look forward to continuing our collaboration in this effort with the FDA.”
Data in the BLA amendment address the FDA's requests outlined in a July 2001 Complete Response Letter. The expanded database in the amendment includes clinical data from more than 6,000 patients, including safety experience from the recently completed ALTO trial with 1,899 patients. To date, approximately 4,000 patients have been treated with Xolair. Xolair is a first-in-class monoclonal antibody to IgE in development under an agreement among Novartis Pharma AG, Genentech and Tanox, Inc. It is the first agent designed to specifically target IgE. In allergic patients, the binding of IgE and allergens to mast cells triggers the mast cells to release inflammatory mediators, such as histamine and leukotrienes, which can lead to the symptoms and inflammation of allergic asthma. By binding to IgE antibodies, Xolair inhibits IgE from attaching to mast cells. Greatly decreasing the IgE bound to mast cells can disrupt an allergen’s ability to trigger the mast cells’ release of the chemical mediators which may lead to the clinical symptoms of allergic asthma. If approved, Xolair would be the first biologic therapy available for the treatment of asthma.
Xolair has already received its first marketing license from health authorities in Austrialia. New data will also be submitted to the European Medical Evaluations Agency (EMEA). Novartis Pharma AG expects to resubmit a Xolair marketing application to the EMEA in the first half of 2004.
Allergic asthma is the most common form of asthma, a chronic inflammatory disorder of the airways. In allergic asthma, exposure to an allergen (such as dust, mold or pollen) triggers an allergic cascade which results in airway obstruction. Asthma results in more than 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.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs.
Fifteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products directly 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.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Novartis Group's ongoing businesses achieved collective sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information, please consult http://www.novartis.com.
The statements made in this press release relating to Xolair as a potential treatment for asthma and the expected regulatory filing time frame in the EMEA are forward-looking and actual results may be materially different. Management's expectations regarding Xolair's asthma treatment potential and the EMEA filing time frame could be affected by, among other things, unexpected safety or efficacy issues, manufacturing issues, additional time requirements to prepare the EMEA filing, discussions with the FDA or EMEA, regulatory delays or government regulation generally, the need for additional clinical studies, failure to receive FDA or EMEA approval and or, the ability to obtain or maintain patent and other proprietary intellectual property protection and competition in general.