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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 20, 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, RespiGam and Synagis are registered trademarks of the Company.
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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 17, 1999:
MEDIMMUNE ANNOUNCES LICENSURE OF MANUFACTURING FACILITY
Gaithersburg, MD, December 17, 1999 - MedImmune, Inc. (Nasdaq: MEDI) today
announced the approval of its new manufacturing facility in Frederick, Maryland
by the U.S. Food and Drug Administration. This approval allows MedImmune to
begin distributing Synagis manufactured at the facility. Synagis (palivizumab)
is a drug used to prevent serious lower respiratory tract disease caused by
respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV
disease (see full prescribing information at www.medimmune.com/ products/
synagispi.htm). This facility will augment the supply of Synagis produced at
Boehringer Ingelheim Pharma KG in Biberach, Germany, under their contract
manufacturing agreement with MedImmune.
Dr. Wayne T. Hockmeyer, MedImmune's chief executive officer and chairman,
stated: "Since MedImmune's inception, our goal has been to be a fully integrated
company, capable of taking a product from discovery through development,
marketing and sales. The licensure of this plant is an important step in this
process and further establishes us as a solid presence in the biotechnology
industry. Many factors contributed to achieving this milestone, including the
dedication and hard work of our employees, as well as the ongoing support of the
state of Maryland and the city and county of Frederick. We thank all those
involved throughout the process and look forward to this manufacturing site
contributing meaningfully to the growth of MedImmune and the community of which
it is a part."
The Frederick manufacturing facility was structurally completed in January 1998.
It is located on a 26-acre site approximately 30 minutes from MedImmune's
headquarters in Gaithersburg, Maryland. With a floor space of approximately
90,000 square feet, the facility includes modules for production of
antibody-based products as well as facilities for quality control, warehousing,
and manufacturing administration.
Synagis is a humanized monoclonal antibody used in the prevention of serious
lower respiratory tract disease caused by RSV in pediatric patients at high risk
of RSV disease, the most common cause of pneumonia and bronchiolitis in infants
and children. Synagis is the first monoclonal antibody to be licensed for any
infectious disease. It is administered by intramuscular injection once per month
during anticipated periods of RSV prevalence, which typically runs from October
through April in the United States, where there are over 300,000 infants at risk
of contracting the disease. In the United States, MedImmune co-promotes the
product with the Ross Products Division of Abbott Laboratories (NYSE:ABT).
Outside the U.S., Abbott International distributes the product.
MedImmune, Inc. is a fully integrated biotechnology company focused on
developing and marketing products that address medical needs in areas such as
infectious disease, transplantation medicine, autoimmune disorders and cancer.
Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities
in Frederick, Maryland and Nijmegen, The Netherlands, and an oncology subsidiary
in West Conshohocken, Pennsylvania.
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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 continue to reflect that seasonality for the
foreseeable future.
MEDIMMUNE, INC.
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(Registrant)
Date: December 20, 1999 By: /s/David M. Mott
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David M. Mott, Vice Chairman and
Chief Financial Officer
