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: May 25, 1999
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 office (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 May 21, 1999:
FOR IMMEDIATE RELEASE
Contacts:
Mark E. Kaufmann Laureen Cassidy
Director, Planning and Analysis Director, International
MedImmune, Inc. Communications
301-417-0770 x321 Abbott Laboratories
847-938-7743
William C. Roberts
Investor and Media Relations
MedImmune, Inc.
301-417-0770 x358
http://www.medimmune.com
http://www.abbott.com
EUROPEAN COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS ADOPTS POSITIVE
OPINION ON SYNAGISTM FOR PREVENTION OF RSV
Abbott Park, IL and Gaithersburg, MD, May 21, 1999 -- Abbott Laboratories
(NYSE:ABT) and MedImmune, Inc. (Nasdaq:MEDI) today announced that the European
Union's Committee for Proprietary Medicinal Products (CPMP) has adopted a
positive opinion on SynagisTM (palivizumab), a monoclonal antibody developed for
the prevention of a serious lower respiratory tract disease caused by
respiratory syncytial virus (RSV). RSV is the most common cause of lower
respiratory infections in infants and children worldwide. The CPMP opinion will
now be considered by the European Commission, which will make a final decision
regarding the issue of a marketing authorization.
Synagis will be the only preventive treatment in Europe for RSV in pediatric
patients under two years old who suffer from lung problems due to chronic
broncopulmonary dysplasia (BPD) or prematurity (less than or equal to 35 weeks
gestational age). Synagis is administered monthly during peak RSV season with an
intramuscular (IM) injection to pediatric patients at high risk from RSV.
During the peak season in Europe, more than 50 percent of hospitalizations due
to respiratory infections in children under two involve RSV. Recommendation for
approval of Synagis is based on a large, randomized study demonstrating a 55
percent reduction in the incidence of hospitalization due to RSV infections in
high-risk pediatric patients.
"The positive opinion is a major step forward in making Synagis available for
children at high risk for RSV, " said David Goffredo, vice president, European
operations, Abbott Laboratories.
The positive opinion follows approvals in several markets, including Argentina,
Australia, Brazil, Colombia, Kuwait, Mexico and the United States.
In December 1997, Abbott Laboratories and MedImmune, Inc., formed an exclusive
worldwide marketing alliance to commercialize Synagis. Abbott has the exclusive
right to market and distribute Synagis outside the United States. In the U.S.,
where Synagis was approved for marketing in June 1998, MedImmune and Abbott have
an agreement to co-promote the product.
Abbott Laboratories is a global, diversified health care company devoted to the
discovery, development, manufacturing and marketing of pharmaceutical,
diagnostic, nutritional and hospital products. Abbott Laboratories is located in
Abbott Park, Ill. The company employs 56,000 people and markets its products in
more than 130 countries.
MedImmune, Inc., located in Gaithersburg, Md., is a biotechnology company
focused on developing and marketing products that address medical needs in areas
such as infectious disease, transplantation medicine, autoimmune disorders and
cancer. MedImmune markets three products through its hospital-based sales force
and has five 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 both
companies' filings with the U.S. Securities and Exchange Commission.
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(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) May 25, 1999
