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: June 22, 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 June 19, 1998:
MEDIMMUNE'S SYNAGIS (palivizumab) APPROVED FOR MARKETING BY FDA
- First Monoclonal Antibody for Infectious Disease-
Gaithersburg, MD, June 19, 1998, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced that Synagis (palivizumab; previously identified as MEDI-493) has
been approved for marketing by the U.S. Food and Drug Administration (FDA) for
the prevention of serious lower respiratory tract disease caused by
respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV
disease (please see full prescribing information at
www.medimmune.com/products/synagispi.htm). Synagis is the first monoclonal
antibody to be licensed for any infectious disease. RSV is the most common
cause of pneumonia and bronchiolitis in infancy and early childhood.
"MedImmune is gratified to be able to introduce this breakthrough product to
protect infants from the serious and potentially life threatening effects of
RSV," said Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer.
"Each year thousands of children die from RSV disease and many more are
hospitalized. Now, a simple injection in the pediatrician's office can
protect many of these children."
Dr. Hockmeyer added, "The speed and thoroughness with which the FDA reviewed
the Synagis Biologic License Application is a testament to FDA's commitment to
children's health. We are grateful to the FDA for their professionalism in
this review and to the many physicians, nurses, parents and children who
participated in the clinical testing of Synagis. All of us should be proud to
bring this advance to pediatric medicine."
In a randomized, double-blind, placebo-controlled Phase 3 clinical trial known
as "IMpact-RSV" evaluating the ability of Synagis to prevent serious RSV
disease in 1,502 high-risk pediatric patients, RSV hospitalizations occurred
among 53 of 500 (10.6%) patients in the placebo group and 48 of 1002 (4.8%)
patients in the Synagis group, a 55% reduction (p<0.001). Synagis was safe
and generally well-tolerated, and the proportions of subjects in the placebo
and Synagis groups who experienced any adverse event or any serious adverse
event were similar.
Synagis is administered by intramuscular injection at 15 mg/kg and is given
once per month during anticipated periods of RSV prevalence in the community.
In the Northern Hemisphere, the RSV season typically commences in October and
lasts through March or April.
In December, 1997, MedImmune formed an exclusive worldwide marketing alliance
with Abbott Laboratories (NYSE:ABT) to commercialize Synagis. Within the
United States, the Ross Products Division of Abbott Laboratories will co-
promote Synagis with MedImmune. MedImmune will record all U.S. sales and
Abbott will receive a commission on sales above pre-determined thresholds.
Each company is responsible for its own selling expenses.
Outside the United States, the International Division of Abbott Laboratories
has the exclusive right to market and distribute Synagis. MedImmune will
manufacture and sell Synagis to Abbott. MedImmune and Abbott expect to submit
regulatory applications in Europe and Canada in the second half of 1998.
MedImmune will receive a $15 million milestone payment from Abbott in
connection with having received marketing approval in the U.S.
MedImmune entered into a manufacturing alliance with Boehringer Ingelheim
Pharma KG ("BI") to supplement its own manufacturing capacity in December
1997. The initial approved manufacturing facility for production of Synagis
is MedImmune's Gaithersburg Manufacturing and Development Facility. FDA is
currently reviewing a supplement to MedImmune's Biologic License Application
to also allow production of Synagis at BI. Product made at BI will be
required for launch of Synagis. Additionally, MedImmune has completed
construction of a manufacturing facility in Frederick, Maryland and plans to
add the Frederick Manufacturing Center as a third production site in the
future, subject to FDA clearance.
RSV is the most common cause of lower respiratory infections in infants and
children worldwide. RSV outbreaks typically occur during the fall, winter and
early spring. Healthy children and individuals with adequate immune systems
often acquire a "cold" when infected with RSV. In contrast, certain high-risk
infants such as premature infants and children with bronchopulmonary dysplasia
(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.
With marketing clearance of Synagis, MedImmune will market the only two
products licensed to prevent RSV disease, Synagis and RespiGam (Respiratory
Syncytial Virus Immune Globulin Intravenous (Human)). RespiGam is a polyclonal
antibody product enriched in neutralizing antibodies against RSV. It was the
first product licensed for the prevention of serious RSV disease in certain
high-risk infants and is administered by an approximately four hour
intravenous infusion given monthly during the RSV season (please see full
prescribing information). Sales of RespiGam during its second full winter RSV
season (1997/1998) were approximately $70 million.
Synagis is a humanized monoclonal antibody. It binds to the "F" protein on
the surface of RSV which is necessary for the virus to infect cells. In
laboratory experiments, Synagis has been shown to neutralize all strains of
RSV tested. Studies in cotton rats, widely thought to be the best model of
RSV infection in humans, have shown that Synagis is 50 to 100 times more
potent than RespiGam, allowing the same anti-viral effect to be delivered in a
much smaller volume. In contrast to RespiGam, which requires slow IV
administration, Synagis is administered as a "single" intramuscular injection;
consequently, it has the potential to enhance patient care, reduce
administration time and costs associated with drug administration and improve
convenience for parents, physicians and nurses. Taken together, these
benefits provide the potential to reach a much broader population of children
with Synagis than with RespiGam. The Company believes Synagis will largely
replace RespiGam in the marketplace and expects to establish a reserve against
current inventories of 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 now will market three products through
its hospital-based sales force and has four 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 MedImmune'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 MedImmune's filings with the U.S. Securities and
Exchange Commission. No assurance can be given that BI will be approved by
the FDA to supply Synagis in time for the RSV season or at all. Supply from
BI is expected to be required to meet market demand. MedImmune cautions that
RSV disease occurs primarily during the winter months; the Company believes
its operating results will reflect that seasonality for the foreseeable
future.
(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) June 22, 1998
