Monday, Dec 2, 1996
South San Francisco, Calif. -- December 2, 1996 --Genentech, Inc. (NYSE: GNE) today announced that Pulmozyme® (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 twelve-week period. Advanced disease is defined by a standard measure of forced vital capacity of less then 40 percent of predicted (FVC <40%). In this study of patients with advanced disease, measures of pulmonary function -- the forced expiratory volume in one second (FEV1) and FVC -- were significantly improved as compared to placebo. In contrast to the mild to moderate CF patient population, no benefit reducing the incidence of respiratory tract infections was seen. The results of this study were published in the October issue of CHEST.
Pulmozyme was safe and generally well tolerated in the advanced CF population. Side effects were similar to those seen in patients with mild to moderate disease, including voice 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 need while researchers continue their search for a cure," added Dr. Johnson.
As CF is a disease that worsens over time, this indication supports continued use of Pulmozyme in patients with an FVC of less than 40 percent.
CF is an inherited disorder that affects about 25,000 Americans, 3,000 Canadians and 20,000 Europeans. A faulty gene in cystic fibrosis patients leads to the production of thick viscous secretions that can cause persistent bacterial infection 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.
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