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 10, 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 December 9, 1998:
MEDIMMUNE REPORTS CYTOGAM RECEIVES FDA APPROVAL
FOR EXPANDED INDICATION
Gaithersburg, MD, December 9, 1998 -- MedImmune, Inc. (Nasdaq: MEDI) today
announced that the United States Food and Drug Administration (FDA) has approved
marketing of an expanded indication for CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human))(CMV-IGIV). Specifically, CytoGam is now indicated for
prophylaxis against cytomegalovirus (CMV) disease associated with
transplantation of kidney, lung, liver, pancreas, and heart. In transplants of
these organs, other than kidney from CMV seropositive donors into CMV
seronegative recipients, CytoGam should be considered in combination with
gancyclovir (please see full prescribing information attached or see
www.medimmune.com/products/cytopil.htm). The prior indication included only
kidney transplants from CMV seropositive donors into CMV seronegative
recipients.
"CMV is the most common cause of infection occurring after any solid organ
transplant," commented David P. Wright, Executive Vice President Marketing &
Sales. "This expanded indication will enable us to market CytoGam for use in the
approximately 20,000 kidney, lung, liver, pancreas, and heart transplants
performed annually in the U.S., rather than being restricted to the roughly
2,000 kidney transplants from CMV seropositive donors to CMV seronegative
recipients."
CMV contributes significantly to morbidity and mortality in organ transplant
recipients. CMV can cause severe pneumonia and other organ complications
related to invasive CMV disease which, if not successfully treated, can lead to
organ failure. CMV has also been shown to cause increased bacterial and fungal
infections, and has been associated with an increased risk of rejection of the
transplanted organ.
CytoGam is an intravenous immune globulin enriched in antibodies against CMV.
CMV-IGIV is made from human plasma and, like other plasma products, carries the
possibility for transmission of blood-borne viral agents. The risk of
transmission of recognized blood-borne viruses is considered to be low because
of the viral inactivation and removal procedures employed in the manufacture of
CytoGam. Minor reactions such as flushing, chills, muscle cramps, back pain,
fever, nausea, vomiting, arthralgia, and wheezing were the most frequent adverse
reactions observed during the clinical trials of CytoGam. CytoGam is marketed by
MedImmune and manufactured by Massachusetts Biologic Laboratories.
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.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) December 10, 1998
