Friday, Sep 19, 1997
South San Francisco, Calif. -- September 19, 1997 --Genentech, Inc. (NYSE: GNE) announced today positive preliminary results from a Phase II trial in which the efficacy of rhuMAb-E25, a recombinant humanized monoclonal antibody to IgE called E25, was tested in adults and adolescents with moderate to severe asthma. Genentech, Novartis Pharma AG and Tanox Biosystems, Inc., have agreed that these results support the continued development of E25 for the treatment of allergic asthma and allergic rhinitis.
In a randomized, multicenter, double-blind, placebo-controlled trial, 317 moderate to severe allergic asthmatics were evaluated. Twenty-seven U.S. sites monitored patients' daily symptoms over a five-month treatment duration. It is anticipated that the results from the Phase II trial will be presented at this year's annual meeting of the American College of Allergy, Asthma and Immunology in San Diego, November 7-12th.
Unlike conventional therapies such as steroids, bronchodilators and antihistamines, E25 is designed to interfere early in the complex, multistep process that leads to the symptoms of allergy in patients who have asthma or rhinitis. Collectively, the three companies have investigated anti-IgE antibodies in 15 clinical studies designed to evaluate the safety of anti-IgE treatment. Currently, E25 is also being evaluated in a pivotal Phase II safety and efficacy trial in 525 patients with allergic rhinitis.
"We are moving forward with Phase III planning based on very encouraging Phase II results," said Arthur D. Levinson, Ph.D., Genentech's president and chief executive officer. Genentech, Novartis and Tanox plan to start Phase III trials of E25 for allergic asthma early in the first quarter of 1998.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science, six of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
Novartis is a world leader in Life Sciences with core businesses in Healthcare, Agribusiness and Nutrition. In 1996, Novartis Group worldwide sales in Life Sciences were 27.6 billion Swiss francs, of which 16.3 billion were in Healthcare, 7.6 billion in Agribusiness and 3.7 billion in Nutrition. The company annually invests more than 3 billion Swiss francs in R&D. Headquartered in Basel, Switzerland, Novartis employs a workforce of about 89,000, and operates in over 100 countries around the world.
Tanox Biosystems, Inc. incorporated in 1986, is a biotechnology research and development company based in Houston, Texas. Tanox is a leader in the development of novel monoclonal antibody-based treatments for diseases involving or affecting the human immune system.
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