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Pulmozyme for Cystic Fibrosis Cleared by the FDA SOUTH SAN FRANCISCO, Calif.-- Dec. 2, 1996-- Genentech, Inc. (NYSE: GNE) today announced that Pulmozyme(R) (dornase alfa) Inhalation Solution, the company's aerosol treatment for cystic fibrosis (CF), has been cleared for marketing by the U.S. Food and Drug Administration (FDA) for treatment of CF patients with advanced disease. Pulmozyme originally received marketing clearance by the FDA in December 1993 for the management of mild to moderate cystic fibrosis in conjunction with standard therapies to reduce the incidence of respiratory tract infections requiring parenteral antibiotics and to improve pulmonary function. The benefit of treatment with Pulmozyme in advanced CF was demonstrated in a placebo-controlled study of 320 patients that examined safety and efficacy of Pulmozyme during a 12-week period. Advanced disease is defined by a standard measure of forced vital capacity of less then 40 percent of predicted (FVC less than 40%). In this study of patients with advanced disease, measures of pulmonary function -- the forced expiratory volume in e alteration, pharyngitis, laryngitis, rash, chest pain and conjunctivitis. However, rhinitis, fever, a decrease in FVC, dyspepsia and serious dyspnea were reported more frequently than in the placebo group. "We are very pleased with the FDA's decision, as treatment options for this group of patients are extremely limited," said Dr. Charles Johnson, clinical scientist, Genentech, Inc. "The treatment of patients with advanced disease fills an unmet medical nection and congestion. As white blood cells attempt to destroy bacteria, they release DNA, which further thickens the secretions. These thick secretions also encourage and prolong respiratory tract infections that damage lung tissue and ultimately lead to death. Today, the average life span for patients with CF is 30 years compared to 14 in 1969. Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, California, and is traded on the New York and Pacific Stock Exchanges under the symbol GNE. E-mail this page to a friend or colleague! To print, use this version