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: January 8, 1997
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 is a registered trademark and
RespiGam is a trademark of the Company.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following
press release dated January 8, 1997.
MEDIMMUNE REPORTS THE PUBLICATION OF RESPIGAM "PREVENT"
STUDY RESULTS IN THIS MONTH'S ISSUE OF PEDIATRICS
--RespiGam Reduces Respiratory Syncytial Virus Hospitalizations--
Gaithersburg, MD, January 8, 1997 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced that a study known as PREVENT, published in this
month's issue of Pediatrics, shows that prophylactic infusions of
RespiGam, Respiratory Syncytial Virus Immune Globulin Intravenous
(Human), (RSV-IGIV), reduce respiratory syncytial virus (RSV)
hospitalizations among premature infants and infants with a chronic
lung condition called bronchopulmonary dysplasia (BPD). In PREVENT,
high-risk children who received monthly prophylactic infusions of
RespiGam had a 41 percent reduction in the incidence of RSV
hospitalization compared to placebo recipients (p less than 0.05). In
addition, administration of RespiGam was shown to be safe and generally
well tolerated. RSV is the leading cause of pneumonia and
bronchiolitis in infants and small children.
"RespiGam is the first and only product demonstrated to be safe and
effective for reducing the incidence and duration of RSV
hospitalization and the severity of RSV illness," commented Ronald L.
Ariagno, M.D., a neonatologist and professor of pediatrics at Stanford
University School of Medicine as well as a PREVENT investigator.
"Because there is no vaccine for RSV prevention at this time, passive
immunization with RespiGam prophylaxis represents a major advance in
protecting high-risk infants from this potentially life-threatening
disease."
RSV is the leading cause of lower respiratory tract infection in
infancy and children worldwide. In the United States, RSV outbreaks
typically occur during the late 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,
premature infants and children with BPD are at increased risk for
acquiring severe RSV disease. In the U.S. alone, over 90,000 children
are hospitalized and 4,500 die from RSV annually. The cost of treating
a high-risk child hospitalized for RSV can be over $70,000.
The PREVENT study was a centrally randomized, placebo-controlled
clinical trial conducted at 54 sites across the United States.
Randomization occurred between November 15, 1994, and December 22,
1994. A total of 510 children with BPD and/or a history of prematurity
were randomized to receive either RespiGam (750 mg/kg; 15 ml/kg) or
placebo, intravenously every 30 days, through April 15, 1995.
The Results
The incidence of RSV hospitalization was reduced by 41 percent in
children receiving RespiGam: 35 (13.5 percent) children in the placebo
group were hospitalized for RSV, compared with 20 (8.0 percent)
RespiGam recipients (p = 0.047). RespiGam recipients had a 53 percent
reduction in the total number of RSV hospital days per 100 children (p
= 0.045), a 60 percent reduction in the number of RSV hospital days
with increased oxygen requirement (p = 0.007), and a 54 percent
reduction in the number of RSV hospital days with a moderate or severe
lower respiratory tract illness (p = 0.049). In addition, children
receiving RespiGam had a 38 percent reduction in hospitalization for
respiratory illness of any cause (p = 0.005) and a 46 percent reduction
in total hospital days for respiratory illness per 100 children (p =
0.005). RespiGam was safe and generally well tolerated, with a safety
profile similar to intravenous infusion of other immune globulin
preparations. Less than 3 percent of children had medically significant
adverse events related to RespiGam administration.
Based on PREVENT data, the U.S. Food and Drug Administration licensed
RespiGam for marketing in January 1996 for the prevention of serious
RSV disease in children less than 24 months old with BPD or a history
of prematurity (i.e., less than or equal to 35 weeks gestation).
[Please see full perscribing information for RespiGam]. RespiGam is
currently being launched by MedImmune in partnership with the Wyeth-
Lederle Vaccines and Pediatrics sales force of American Home Products
Corporation. Massachusetts Public Health Biologic Laboratories
manufactures RespiGam.
MedImmune, Inc. 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 currently
markets two products through its hospital-based sales force and has
seven new product candidates in clinical trials. MedImmune is located
in Gaithersburg, MD.
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.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
MEDIMMUNE, INC.
Registrant)
Date: January 8, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
