Tuesday, Mar 30, 1993
South San Francisco, Calif. -- March 30, 1993 --Genentech, Inc. (NYSE:GNE) today announced that it has filed a Product License Application (PLA) with the U.S. Food and Drug Administration (FDA) to seek approval to market Pulmozyme (dornase alfa) recombinant human DNase for patients with cystic fibrosis. The company also has submitted marketing applications for Pulmozyme in Canada and Europe.
"These regulatory filings are the culmination of an intensive effort on the part of literally hundreds of Genentech employees, the Cystic Fibrosis Foundation, Cystic Fibrosis Centers across the country, the FDA and the Canadian and European regulatory agencies," said G. Kirk Raab, Genentech president and chief executive officer. "This collaborative effort has allowed us to develop Pulmozyme in just four years, less than half the industry average for development of a new drug."
The 968-patient Phase 111 clinical trial demonstrated Pulmozyme reduces the rate of respiratory infection and improves lung function in cystic fibrosis patients. No major adverse side effects were noted.
There are an estimated 30,000 Americans, almost 3,000 Canadians, and approximately 20,000 Europeans who suffer from cystic fibrosis. The median survival age is 29 years.
As part of a co-marketing agreement in Europe, Genentech Europe Ltd. and Roche have simultaneously filed applications to obtain approval in 13 European countries. Genentech Canada has also submitted an application to the Bureau of Biologics, Health Protection Branch in Canada.
Cystic fibrosis is the most common fatal genetic disease in Caucasians. Because of a genetic defect, individuals with cystic fibrosis have thick lung secretions accumulating in their lungs, causing impaired breathing, persistent lung infection and progressive degeneration of lung function. In these people, DNA is released by white blood cells fighting the infections characteristic of cystic fibrosis, causing the already abnormal mucus to become more thick or viscous. Sometimes referred to as "molecular scissors," Pulmozyme cuts up the excess DNA in these secretions, helping patients clear their airways and breathe easier and reducing the frequency of respiratory infections.
Genentech, Inc., is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant 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.
# # #