The European Committee for Proprietary Medicinal Products(CPMP) has issued a unanimous recommendation for approvalof Pulmozyme for treating cystic fibrosis, Genentech Inc.announced Friday.
The CPMP members represent the 12 European Union (EU)member states, each of which must now decide whether togrant a marketing authorization for the drug. "We anticipatethat the marketing authorization authorities in the individualstates will follow this recommendation," said Jim Weiss,Genentech's manager of corporate communications.
F. Hoffmann-La Roche Ltd. of Basel, Switzerland, whichsubmitted the product license application (PLA) to the CPMP onMarch 31, and Genentech Europe Ltd. will promote Pulmozymejointly in Western Europe.
Pulmozyme, or dornase alfa, is a recombinant human DNasethat acts as a therapy for cystic fibrosis (CF) by liquefying thethick mucous that is produced in the lungs by patients withthis hereditary disease. In clinical trials, the drug has beenshown to reduce the rate of respiratory infection in CF patients,as well as significantly improve their lung function. Based onthese Phase III data, the U.S. FDA's Pulmonary Allergy DrugsAdvisory Committee voted 7-0 to recommend Pulmozyme formarketing approval on Aug. 9.
Genentech of South San Francisco, Calif., is still waiting to hearfrom Canada's Health Medicines Branch; it filed for regulatoryapproval in Canada on March 26.
Genentech will promote Pulmozyme exclusively in the U.S. andCanada, and Roche has an exclusive license to the productoutside Western Europe, North America and Japan.
Genentech's stock (NYSE:GNE) closed Friday at $48.75 a share,down 13 cents.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.