Monday, Nov 9, 1998

New Investigational Data Show Monoclonal Antibody to IgE May Reduce Seasonal Allergy Symptoms

Investigational drug targets source of allergic reactions rather than symptoms

Philadelphia, Penn. -- November 9, 1998 --

A recombinant humanized monoclonal antibody to IgE may reduce the occurrence and severity of nasal and ocular symptoms associated with seasonal allergic rhinitis (SAR) -- commonly known as hay fever -- according to a study presented today at the American College of Allergy, Asthma and Immunology. The investigational drug, called rhuMAb-E25, also known as anti-IgE, is a recombinant humanized monoclonal antibody to IgE (immunoglobulin E) that is intended to interfere early in the allergic process.

According to the preliminary Phase II/III dose ranging data, the occurrence and severity of daily nasal symptoms, such as sneezing, runny and stuffy nose, and ocular symptoms such as itchy, watery, red eyes, was reduced for the anti-IgE groups as compared to placebo during the pollen season. In addition, the use of rescue allergy medication, such as antihistamines and decongestants, was lower in the anti-IgE treated groups than in the placebo group.

"An investigational compound such as anti-IgE may offer new hope to allergy sufferers everywhere because it targets the source of the allergic reaction rather than merely the symptoms," said Dr. Thomas B. Casale, Director of the Nebraska Medical Research Institute, Adjunct Professor of Pediatrics at the University of Nebraska Medical Center and lead investigator for the Phase II/III clinical trial.

The randomized, double-blind, placebo-controlled, multicenter trial evaluated 536 patients of either sex, ages 12--75 with a history of moderate to severe ragweed induced SAR. Patients were treated with anti-IgE at 300mg, 150mg, 50mg or placebo over a period of 12 weeks, beginning two weeks prior to the start of the pollen season. This preliminary investigational trial showed a dose-related decrease in nasal and ocular symptom severity and frequency, and as much as a 50 percent decrease in the number of days patients required rescue medication in the 300mg group as compared to placebo.

Other than drug-related urticaria, reported in two anti-IgE treated patients (0.5 percent), the incidence of adverse experiences was similar for the anti-IgE and placebo groups. None of the anti-IgE treated patients developed antibodies to the anti-IgE protein.

Anti-IgE is a recombinant humanized monoclonal antibody that has been developed to target the source of allergy symptoms for all allergens. Anti-IgE inhibits the allergic response by binding to IgE, thereby blocking the consequent release of inflammatory mediators such as histamine, prostaglandins and leukotrienes. These inflammatory mediators play a role in the pathology of allergic disease such as allergic asthma, allergic rhinitis and atopic dermatitis.

Genentech, Inc., Novartis Pharma AG and Tanox Biosystems, Inc. are the three companies currently collaborating on Phase III research with rhuMAb-E25, which is being investigated as a treatment for allergy and allergic asthma.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Twelve of the currently marketed biotechnology products stem from Genentech science, seven 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 Consumer Health (Self-Medication and Nutrition). In 1997, Novartis Group sales were 31.2 billion Swiss francs, of which 17.0 billion were in Healthcare, 8.3 billion in Agribusiness and 5.9 billion in Consumer Health. The group annually invests more than 3.6 billion Swiss francs in R&D. Headquartered in Basel, Switzerland, Novartis employs a workforce of about 86,000 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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