MedImmune Inc. announced Monday that it has filed a productlicense application (PLA) with FDA for Respivir, its polyclonalantibody product for prevention of respiratory syncytial virus(RSV) disease in children.
The Gaithersburg, Md., company (NASDAQ:MEDI) completed anefficacy trial for the product last April. The trial, begun in 1989and conducted at five centers in the U.S., is the basis of thePLA. No trial results have been made public. The firstpresentation of data is scheduled for May at a meeting of theSociety of Pediatric Research.
RSV is the leading cause of pneumonia and bronchiolitis inchildren. RSV infections in children account for roughly 90,000hospitalizations and 4,500 deaths each year in the U.S. Noproduct is currently licensed in the U.S. for prevention of RSVdisease. MedImmune is currently testing Respivir as atreatment for RSV and may file an application for thatindication by the end of the year.
In a separate development, MedImmune announced Mondaythat Merck & Co. has initiated a review of the companies'collaboration for development of a human monoclonal antibodyproduct called MEDI 488, which may have potential inpreventing HIV infection. MedImmune said "unexpectedresearch results" with MEDI 488 caused Merck to re-evaluatethe program. The two companies will decide within two monthswhether or not to continue the collaboration.
MedImmune's stock closed Monday at $23.25, up 25 cents ashare.
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