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: November 13, 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 November 12, 1998:
MEDIMMUNE ANNOUNCES ISSUANCE OF U.S. PATENT FOR SYNAGIS
Gaithersburg, MD, November 11, 1998 -- MedImmune, Inc. (Nasdaq: MEDI) today
announced that it has been granted United States patent No. 5,824,307 for
humanized antibody against respiratory syncytial virus (RSV) that covers Synagis
(palivizumab; previously identified as MEDI-493). Synagis is marketed by
MedImmune for the prevention of serious lower respiratory tract RSV disease in
pediatric patients at high risk for RSV disease. Additional patent applications
relating to Synagis have been filed by the Company and are pending.
Synagis is a humanized monoclonal antibody which was approved for marketing in
June 1998 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). Synagis is
the first monoclonal antibody to be licensed for any infectious disease.
Synagis is administered by intramuscular injection once per month during
anticipated periods of RSV prevalence in the community. RSV is the most common
cause of pneumonia and bronchiolitis in infants and children. In the Northern
Hemisphere, the RSV season typically commences in November and lasts through
April.
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. 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, Vice Chairman and Chief Financial Officer
(DATE) November 13, 1998