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: September 9, 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 September 8, 1998:
PHASE 3 RESULTS FOR MEDIMMUNE'S SYNAGIS
PUBLISHED IN PEDIATRICS
Gaithersburg, MD, September 8, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced that results from the IMpact-RSV study, the pivotal phase 3 clinical
trial of Synagis (palivizumab), have been published in the medical journal
Pediatrics. As the official journal of the American Academy of Pediatrics,
Pediatrics is the most widely read periodical specializing in pediatric medicine
with a circulation of 60,000 including pediatricians and other health care
professionals.
In the study, the primary endpoint of the trial was achieved: administration of
Synagis resulted in a 55 percent reduction (p=0.00004) in hospitalization caused
by respiratory syncytial virus (RSV). Synagis was recently approved for
marketing by the U.S. Food and Drug Administration (FDA) for the prevention of
serious lower respiratory tract disease caused by respiratory syncytial virus
(RSV) in pediatric patients at high risk of RSV disease (please see full
prescribing information at www.medimmune.com/products/synagispi.htm). RSV is
the most common cause of pneumonia and bronchiolitis in infancy and early
childhood. Synagis is expected to be launched in the United States during the
next few weeks to protect babies during the upcoming RSV season.
"The IMpact-RSV trial and its publication are the culmination of years of work
by pediatric investigators who participated in the clinical development of
Synagis throughout the world," commented Edward M. Connor, MD, Vice President,
Clinical Research at MedImmune. "The data presented in the Pediatrics paper
represents a milestone in the fight to prevent the serious consequences of RSV
infection in premature babies. We are proud to know that many of these fragile
premature infants will be able to benefit from this breakthrough product."
The article, titled "Palivizumab, a Humanized Respiratory Syncytial Virus
Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus
Infection in High-risk Infants," is published in this month's, Pediatrics, Vol.
102, No. 3 pp. 531-537. An abstract of the article can be found at
http://www.pediatrics.org/current.shtml#article.
RSV is the most common cause of lower respiratory infections in infants and
children worldwide. RSV outbreaks typically occur during the fall, winter and
early spring. 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 bronchopulmonary
dysplasia (BPD) are at increased risk for acquiring severe RSV disease
(pneumonia and bronchiolitis), 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. In the Northern
Hemisphere, the RSV season typically commences in October and lasts through
March or April. Synagis, a humanized monoclonal antibody, is administered by
intramuscular injection at 15 mg/kg and is given once per month during
anticipated periods of RSV prevalence in the community.
MedImmune, Inc. 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 now will market three products through its
hospital-based sales force and has four new product candidates in clinical
trials. MedImmune is located in Gaithersburg, MD.
This announcement may contain, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties. Such
statements reflect MedImmune'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 MedImmune's filings with the U.S. Securities and
Exchange Commission. MedImmune cautions that RSV disease occurs primarily during
the winter months; the Company believes its operating results will reflect that
seasonality for the foreseeable future.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, President and Chief Operating Officer
(Principal financial and accounting officer)
(DATE) September 9, 1998
