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: May 19, 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 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 May 7, 1999:
FOR IMMEDIATE RELEASE
Contacts:
Mark E. Kaufmann
Director, Planning and Analysis
MedImmune, Inc.
301-417-0770 x321
William C. Roberts
Investor and Media Relations
MedImmune, Inc.
301-417-0770 x358
http://www.medimmune.com
MEDIMMUNE ANNOUNCES PRESENTATION OF PHARMACOECONOMIC DATA FOR SYNAGIS -
RSV-Related Abstracts and Presentations at Pediatric Academic Societies'
Meeting -
Gaithersburg, MD, May 7, 1999 -- MedImmune, Inc. (Nasdaq:MEDI) today announced
the presentation of study results related to respiratory syncytial virus (RSV)
this week at the 1999 Pediatric Academic Societies' Annual Meeting in San
Francisco. Several noteworthy abstracts relating to RSV disease and its
prevention were accepted for publication or presentation at the conference,
among which were: 1) an economic study which showed that RSV prophylaxis with
Synagis (palivizumab; previously identified as MEDI-493) reduced RSV
hospitalization and its related costs, 2) a study showing the increasing costs
associated with RSV pneumonia in infants, and 3) a preclinical study which
showed that prophylaxis of RSV with Synagis in an animal model reduced
RSV-associated lung inflammation, which has been associated in humans with
subsequent development of asthma. RSV is the most common cause of pneumonia and
bronchiolitis in infants and children. Abstracts may be obtained at
www.aps-spr.org/meetings/1999/abstracts.htm.
"The pharmacoeconomic data presented at this year's Pediatric Academic
Societies' meeting provides important new information about the potential
benefits to the health care system of preventing RSV disease in high-risk
patients," commented Franklin H. Top, Jr., M.D., Executive Vice President and
Medical Director at MedImmune. "Additionally, we are eager to explore the
connection between RSV and asthma. It is encouraging to see that prophylaxis
with Synagis in an animal model prevented some of the mechanisms associated with
asthma."
In the first study, "Expected Economic Impact of Respiratory Syncytial Virus
(RSV) Prophylaxis," by Albert Marchetti, M.D., Vice President and Medical
Director of Health Economics Research, et al., costs for protection and disease
were compared including Synagis-related expenses and costs for in-patient and
out-patient resources to treat RSV disease. The study used statistics from
various sources including clinical trials conducted by MedImmune and published
epidemiological studies to assess the cost-benefit of Synagis. Hospital billing
records and public sources were utilized to determine charges related to
prophylaxis and medical management of RSV infection. Results showed that the
economic impact of widespread use of Synagis ranged from an average incremental
charge of $2,880 per patient to average savings per patient of $39,107.
"This is the first broad analysis of the cost-benefit of Synagis which takes
into account the full range of available data regarding Synagis-related
expenses and RSV infection treatment," commented Dr. Top.
The second study, "The Rising Costs of RSV Pneumonia in the Hospital: US Data
from 1993-1994," was a retrospective database analysis to determine the trends
of costs, length of stay, and severity associated with RSV pneumonia in infants
less than or equal to two years of age. The study was presented by Timothy
Howard, President, and Paul Stang, Ph.D., Vice President and Chief Science
Officer, of Galt Associates, a company that provides epidemiology and drug
safety research and analysis services. Clinical and hospital resource use data
was derived from discharge abstracts from 1993-1994 found in the Nationwide
Inpatient Sample (NIS) database, a multi-state integrated database coordinated
by the Agency for Health Care Policy and Research. The database contains patient
information from 6.5 million in-patient stays annually from 900 hospitals in 17
states. RSV pneumonia accounted for 0.35 percent of all discharges in infants
less than or equal to two years of age, and both the number of discharges and
total charges (in 1997 dollars) for RSV pneumonia rose from 1993 to 1994 (20
percent increase in discharges from 15,826 to 18,965 and 30 percent increase in
total charges from $262 million to $341 million). The mean charges of admission
for infants with comorbidities and RSV pneumonia, for whom prophylaxis with
Synagis is now available, rose from $57,322 to $61,679 from 1993 to 1994.
"This study is the most recent and comprehensive analysis of costs to the
healthcare system of RSV pneumonia," added Dr. Top. "Quite frankly, the
increase in both discharges and total charges for RSV pneumonia surprised
us."
The third presentation, "Humanized Monoclonal Antibody against Respiratory
Syncytial Virus (Palivizumab) Prevents RSV-induced Neurogenic Inflammation in
Rat Airways," by Giovanni Piedimonte M.D et al., showed that prophylactic
administration of Synagis in an animal model prevented RSV-associated neurogenic
inflammation of the lower airway, which may be a component of asthma development
caused by viral infection in humans. Rats received a single dose of either
Synagis or a placebo. Prophylaxis with Synagis reduced neurogenic lung
inflammation by 61 percent compared to the placebo control (p=0.0005). Dr.
Piedimonte is the Associate Professor of Pediatrics, Medicine and Pharmacology
and Director of Pediatric Pulmonary Division at the University of Miami School
of Medicine
"While this preliminary study is consistent with current literature suggesting
that RSV may be implicated in the development of asthma, this study does not
prove this hypothesis or that RSV prophylaxis may prevent asthma," said Dr. Top.
"MedImmune intends to further study the potential role of Synagis in preventing
asthma in humans and the long-term problems associated with RSV infection."
Other noteworthy studies presented at the conference included 1) "Evaluation of
Immunogenicity and Safety in Children Receiving Palivizumab (Synagis) for a
Second RSV Season," by Dr. Donald M. Null, M.D, Director, Division of
Neonatology and Professor of Pediatrics at Allegheny General Hospital, et al.,
where Synagis was found to be safe and well tolerated, and additional doses did
not result in anti-Synagis antibodies in this population; 2) "Evaluation of
Reconstituted Lyophilized Palivizumab (Synagis) given intravenously at 15 and 30
mg/kg.," by Bernard S. Landry, M.P.H., Assistant Director of Clinical
Development at MedImmune, et al., which suggested that intravenous
administration of 15 and 30 mg/kg of Synagis using a 0.22 micron filter was
generally safe and well-tolerated; and 3) "Healthcare Resource Utilization by
Respiratory Syncytial Virus Disease Patients," by Todd L. Wandstrat, Pharm.D.,
Associate Professor, Department of Clinical Pharmacy and Family Medicine at West
Virginia University, et al., which was a 43 patient study concluding that RSV
disease causes significant in-patient and out-patient healthcare resource
utilization and that prophylaxis with RespiGam (Respiratory Syncytial Virus
Immune Globulin Intravenous (Human)) reduced resource utilization.
Synagis is a humanized monoclonal antibody marketed by MedImmune in the United
States for the prevention of serious lower respiratory tract disease caused by
RSV in pediatric patients at high risk of RSV disease (please see full
prescribing information attached and at ww.medimmune.com/products/
synagispi.htm). Synagis is the first monoclonal antibody to be licensed for any
infectious disease. Synagis is administered by intramuscular injection once per
month during anticipated periods of RSV prevalence in the community. In the
Northern Hemisphere, the RSV season typically commences in November and lasts
through April but it may begin earlier or persist later in certain communities.
RSV is the most common cause of pneumonia and bronchiolitis in infants and
children. There are over 300,000 infants at risk of RSV in the United States. In
the U.S. alone, over 90,000 children are hospitalized and the mortality rate of
hospitalized infants with RSV infection of the lower respiratory tract is about
2 percent. Sales of Synagis through March 31,1999 for the 1998/1999 RSV season
totaled $226 million. MedImmune co-promotes Synagis in the United States with
the Ross Products division of Abbott Laboratories (NYSE:ABT).
MedImmune, a biotechnology company located in Gaithersburg, Maryland, develops
and markets products that address medical needs in areas such as infectious
disease, transplantation medicine, autoimmune disorders and cancer. The Company
currently markets Synagis (palivizumab), RespiGam (Respiratory Syncytial Virus
Immune Globulin Intravenous (Human)), and CytoGam (Cytomegalovirus Immune
Globulin Intravenous (Human)) through its hospital-based sales force and has
five 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. 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.
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(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) May 19, 1999
