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MEDIMMUNE FILES WITH FDA FOR APPROVAL OF NEW DRUG FOR PREVENTION OF CHILDHOOD PNEUMONIA

 GAITHERSBURG, Md., Jan. 4 /PRNewswire/ -- MedImmune, Inc., (NASDAQ: MEDI) announced the filing with the United States Food and Drug Administration (FDA) of a Product License Application (PLA) for Respivir (TM). Respivir is a unique polyclonal antibody product for prevention of respiratory syncytial virus (RSV) disease in children. RSV is the leading cause of pneumonia in children.
 "The Respivir PLA filing is an important milestone in the development of MedImmune as an integrated biotechnology company developing and marketing its own products," said Wayne T. Hockmeyer, Ph.D., chief executive officer. "Respivir has the potential to reduce serious RSV disease in children and could be a major advance in pediatric healthcare, if and when approved by the FDA."
 RSV is the leading cause of pneumonia and bronchiolitis in children. Severe RSV disease occurs most frequently in children less than two years of age. More than 90,000 hospitalizations and 4,500 deaths occur each year in the United States as a result of RSV infection in children. RSV infection is the major cause of hospitalization in premature infants and infants with lung disease. No product is currently licensed for prevention of RSV infection in the United States.
 The duration of RSV infection is usually seven to 21 days. In children under the age of two, infection is characterized by fever, coughing and wheezing and in more severe cases results in severe bronchiolitis or pneumonia. Children with pre-existing conditions, including lung or heart disease, prematurity or immunosuppression, are at significantly increased risk for severe disease and death from RSV. Neonatalogists and other physicians who care for these high-risk children fear RSV pneumonia as one of the most serious diseases of childhood.
 RSV disease frequently leads to expensive and lengthy hospitalization and often intensive care unit admission for infected children. Duration of hospitalization is typically three to seven days, with children from high risk groups being prone to much longer inpatient stays and increased risk of death from RSV and its complications. Current treatment for RSV disease typically consists of supportive therapy such as supplemental oxygen or mechanical ventilation.
 MedImmune began a pivotal efficacy trial for prevention of RSV disease in children in 1989. The trial has been conducted in five centers throughout the United States and through three RSV seasons. Physicians involved in the trial include leading experts in RSV and respiratory disease in children. The trail was concluded in April 1992, and its results provide the basis for the PLA submission.
 As a result of agreements with the physician investigators involved in the RSV prevention trial, MedImmune is not in a position to discuss the results of the trial until the physicians have publicly presented the data. The first presentation of data is planned for the Society of Pediatric Research meeting scheduled for the first week in May 1993. Results of the trial are also being prepared by the investigators for publication in a medical journal.
 Respivir, if and when approved by the FDA, will be delivered by intravenous infusion once per month during RSV season (approximately five months). Initial infusions are likely to occur in hospital clinics, with subsequent infusions either in hospital clinics or through home infusion care. Respivir will be promoted by MedImmune's own hospital sales force in the United States and is expected to be introduced outside the United States through a marketing partner not yet selected by MedImmune.
 In addition to the clinical trial for prevention of RSV described above, MedImmune is in the final year of two separate three year, multi- center efficacy trials with Respivir for treating children with RSV disease. If successful, these trials could provide the basis for an application to be filed with the FDA late in 1993 for use of Respivir to treat RSV pneumonia and bronchiolitis.
 Dr. Hockmeyer added that, "Respivir, if and when PLA is approved by the FDA, has the potential to generate significant product sales for MedImmune. We also expect that Respivir could reduce the overall healthcare cost associated with RSV disease by among other things reducing the incidence of hospitalization and intensive care unit admission."
 MedImmune, Inc. was formed in 1988 to develop, manufacture and market therapeutics and vaccines for the treatment and prevention of certain infectious diseases and cancers. MedImmune's corporate headquarters are in Gaithersburg, Md.
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 /CONTACT: David M. Mott, vice president of business development and planning of MedImmune, Inc., 301-417-0770, or Anthony J. Russo, Ph.D., of Noonan/Russo Communication, Inc., 212-979-9180, for MedImmune, Inc./
 (MEDI)


CO: MedImmune, Inc. ST: Maryland IN: MTC SU:

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Date:Jan 4, 1993
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