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ViroPharma's Buccolam® (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures
Date:9/6/2011

EXTON, Pa., Sept. 6, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the European Commission has granted a Centralized Pediatric Use Marketing Authorization (PUMA) for Buccolam® (midazolam, oromucosal solution), for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age.  This action by the European Commission represents the first product approval through the centralized PUMA procedure since its inception.

In connection with the approval of Buccolam, ViroPharma will make an additional payment of 10 million Pounds Sterling (approximately $16.3 million based on the August 31, 2011 exchange rate) to the former owners of Auralis Limited.

"Prolonged acute convulsive seizures remain a significant and all-too-common health threat in the paediatric and adolescent populations," commented Prof. Lieven Lagae, of the Department of Paediatric Neurology at the University Hospitals KU Leuven in Belgium.  "Historically, these dangerous seizures have been managed with rectally-administered diazepam, which, while effective, presents certain challenges including social acceptance and difficulties in administration.  The approval of Buccolam provides a welcomed alternative for the physicians, families and caregivers of children and adolescents who suffer from these seizures, and will dramatically change the treatment paradigm in this population of patients."

Buccolam is oromucosal midazolam provided in a pre-filled, age-specific dose formulation for convenient buccal (i.e. via the cavity between the cheek and gum) delivery. Buccal midazolam has been shown in four clinical studies to be either comparable or superior in both its effectiveness and speed of onset of action to the current standard treatment, rectally-administered diazepam, for termi
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SOURCE ViroPharma Incorporated
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