SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: December 23, 1998
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 52-1555759
(State of Incorporation) (I.R.S. Employer
Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
CytoGam and RespiGam are registered trademarks of the Company and Synagis is a
trademark.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated December 22, 1998:
MEDIMMUNE ANNOUNCES SYNAGIS PUBLICATION
Pediatric Data Presented in the December Edition of The Journal of Infectious
Diseases
Gaithersburg, MD, December 22, 1998 -- MedImmune, Inc. (Nasdaq: MEDI) today
announced the publication of pediatric clinical data on the use of Synagis
(palivizumab; previously identified as MEDI-493) in The Journal of Infectious
Diseases. The results support a connection between administering Synagis to RSV-
infected pediatric patients and decreasing the amount of RSV in the respiratory
tract. Synagis is marketed by MedImmune for the prevention of serious lower
respiratory tract RSV disease in pediatric patients at high risk for RSV disease
(please see full prescribing information attached or see
http://www.medimmune.com/products/synagispi.htm). Synagis is the first
monoclonal antibody to be licensed for marketing by the U.S. Food and Drug
Administration (FDA) for any infectious disease.
"The study presented in The Journal of Infectious Diseases provides important
insight into the activity of Synagis in vivo," commented Franklin H. Top, Jr.,
MD, Executive Vice President and Medical Director at MedImmune. "The data show
a significant antiviral effect of Synagis in the lower respiratory tract, the
primary target organ for prophylaxis."
The title of the article is "Reduction of Respiratory Syncytial Virus (RSV) in
Tracheal Aspirates in Intubated Infants by Use of Humanized Monoclonal Antibody
to RSV F Protein" (Vol. 178: pp. 1555-61). In this study, the antiviral effects
of Synagis were evaluated by comparing the concentration of RSV in the tracheal
secretions of severe RSV-infected intubated infants, before and after a single
intravenous infusion of Synagis or placebo. The physicians showed that the
administration of 15mg/kg Synagis was generally safe and well-tolerated in this
population of children suffering from RSV-related respiratory failure, and that
the reduction of tracheal RSV over a one and two-day period was significantly
greater in the children treated with Synagis compared to the placebo group.
RSV typically occurs during the fall, winter and early spring, and is the most
common cause of pneumonia and bronchiolitis in infants and children at risk of
RSV disease worldwide. Healthy children and individuals with adequate immune
systems often acquire a benign chest cold when infected with RSV. In contrast,
certain high-risk infants such as premature infants and children with chronic
lung disease (CLD), also known as bronchopulmonary dysplasia (BPD), are at
increased risk for acquiring severe RSV disease, often requiring
hospitalization. Each year in the United States, more than 90,000 infants are
hospitalized with RSV disease. The mortality rate of hospitalized infants with
RSV infection of the lower respiratory tract is about 2 percent. There are
approximately 325,000 infants at high risk of acquiring severe RSV disease in
the U.S.
MedImmune, located in Gaithersburg, Maryland, is a biotechnology company focused
on developing and marketing products for the prevention and treatment of
infectious diseases and for use in transplantation medicine. MedImmune markets
three products through its hospital-based sales force and has four new product
candidates in clinical trials.
This announcement may contain, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties. Such
statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in the Company's filings with the U.S. Securities and
Exchange Commission.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ Melvin D. Booth
(NAME AND TITLE) Melvin D. Booth, President and Chief Operating Officer
(DATE) December 23, 1998
