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 22, 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 and RespiGam are registered trademarks 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 December 19, 1997:
MEDIMMUNE REQUESTS MARKETING CLEARANCE OF MEDI-493
Gaithersburg, MD, December 19, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced that it has submitted a Biologic License Application (BLA) to the
U.S. Food and Drug Administration (FDA) requesting marketing clearance of
MEDI-493 (palivizumab). The Company also announced that it has selected
SynagisT as the trade name for the product. Palivizumab is a humanized
monoclonal antibody being developed by MedImmune for prevention of serious
respiratory syncytial virus (RSV) disease in infants and young children.
"Submission of the palivizumab BLA to the FDA is an important milestone for
MedImmune. This submission is the culmination of more than eight years of
research and development effort by our employees and collaborators,"
commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer.
"We are grateful to each of them for their contributions and dedication to
this effort. We also hope that the many parents and children who
participated in the clinical trials of palivizumab share our pride in what
has been accomplished and our excitement about the potential for their
efforts to benefit thousands more children and their parents in the future."
On July 16, 1997, MedImmune reported preliminary results of a randomized,
double-blind, placebo-controlled Phase 3 clinical trial known as "IMpact-RSV"
evaluating the ability of palivizumab to prevent serious RSV disease in high-
risk infants and children. Analysis of the results suggested that
palivizumab reduced the incidence of RSV-associated hospitalizations by fifty-
five percent (p=0.00004). IMpact-RSV was conducted at 139 clinical centers
in the United States, Canada and the United Kingdom. The study included
1,502 high-risk infants who were either less than six months of age with a
history of prematurity (i.e., less than or equal to 35 weeks gestation) or
less than twenty-four months of age with a serious lung condition called
bronchopulmonary dysplasia (BPD). In the Company's analysis, certain of the
secondary endpoints also reached statistical significance including RSV
hospital days, RSV ICU admissions and RSV hospital days with increased
supplemental oxygen. Data are subject to full review by regulatory
authorities before a definitive assessment of the safety and efficacy of
palivizumab can be made.
RSV is the most common cause of lower respiratory infections in infants and
children worldwide. 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 (pneumonia and bronchiolitis), often requiring
hospitalization. In the United States alone, over 90,000 children are
hospitalized and 4,500 die from RSV disease annually. The cost of treating a
high-risk child hospitalized for RSV can be over $70,000.
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 five new product
candidates in clinical trials. MedImmune expects to file a supplement to its
BLA for additional manufacturing capacity utilizing Boehringer Ingelheim's
Thomae facility in Biberach, Germany. Product manufactured at the Thomae
facility will be required to supplement the launch if palivizumab is approved
by regulatory authorities. 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. MedImmune cautions that there can be no assurance that
palivizumab will be licensed for marketing by regulatory authorities.
(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) December 22, 1997
