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:
FDA APPROVES ADDITIONAL MANUFACTURING FACILITY
FOR MEDIMMUNE'S SYNAGIS
- Shipments to customers expected to begin in September -
Gaithersburg, MD, September 8, 1998 -- MedImmune (Nasdaq:MEDI) today announced
that the United States Food and Drug Administration (FDA) has approved
MedImmune's supplement to its Biologic License Application (BLA) submitted for
the manufacture of Synagis (palivizumab) at MedImmune's contract manufacturer,
Boehringer Ingelheim Pharma KG (formerly, Dr Karl Thomae GmbH), a fully-owned
subsidiary of Boehringer Ingelheim (BI). The approval will allow MedImmune to
import and sell in the United States product from the German BI facility
including product already produced. MedImmune established a manufacturing and
supply agreement with BI in December, 1997 to supplement MedImmune's own
capacity and will use product from BI to launch Synagis in the United States.
Synagis is a humanized monoclonal antibody developed 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.
"Both the FDA and Boehringer Ingelheim should be commended for the expertise and
diligence which it took to ensure that the BI facility would be licensed and
product supply would be available in time for this RSV season," commented Wayne
T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer. "The FDA has
continued to do an outstanding job throughout the review and licensure process
for Synagis. Boehringer Ingelheim has validated our rationale for selecting them
as our manufacturing partner for Synagis and has demonstrated once again their
world leading capability in recombinant protein production."
Dr. Hockmeyer added that, "MedImmune and our marketing partners at Abbott
Laboratories are now completing the final preparations for the Synagis launch
and expect to begin shipping product to customers later this month. Together,
we are thrilled to be introducing the first monoclonal antibody for an
infectious disease, a breakthrough product with the ability to prevent a life-
threatening disease in high risk infants."
Synagis was approved for marketing in June 1998 by the FDA. Synagis is the first
monoclonal antibody licensed in the United States for any infectious disease.
Synagis is administered by intramuscular injection at 15 mg/kg and is given once
per month during anticipated periods of RSV prevalence in the community.
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.
Boehringer Ingelheim is a world-leading manufacturer of biopharmaceutical
products for therapeutic use. The BI facility, located in Biberach, Germany, is
fully licensed by both the U.S. and European regulatory authorities for
commercial biologics production for third parties and provides state-of-the-art
cell culture production capabilities. MedImmune currently manufactures Synagis
at its facility in Gaithersburg, Maryland, but BI is expected to provide the
majority of product for launch and will continue to supplement MedImmune's
capacity during future RSV seasons. MedImmune has also recently completed
construction of a manufacturing facility in Frederick, Maryland, and following
start-up and validation procedures, expects to seek licensure to produce Synagis
at that facility.
MedImmune 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.
MedImmune is located in Gaithersburg, MD.
Boehringer Ingelheim, an international corporation with headquarters in
Ingelheim, Germany, operates in the pharmaceutical, biological and chemical
sectors. The Boehringer Ingelheim Corporation is represented on every
continent, with about 160 companies around the world. With its own research,
production and distribution facilities, it ranks among the top 20 pharmaceutical
companies in the world.
This announcement contains, 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, President and Chief Operating Officer
(Principal financial and accounting officer)
(DATE) September 9, 1998
