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: November 4, 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, RespiGam and Synagis are registered trademarks of the Company.
<PAGE>
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated November 4, 1999:
FOR IMMEDIATE RELEASE
SAFETY AND EFFICACY OF SYNAGIS (palivizumab) REAFFIRMED AFTER
FIRST SEASON'S USE; MEDIMMUNE PRESENTS DATA AT
SECOND WORLD CONGRESS OF PEDIATRIC INFECTIOUS DISEASES
Data Presented
o Efficacy and Safety Data from First Season of Use in United States
o Results of an Expanded Access Study in 15 Countries
Gaithersburg, MD, November 4, 1999 - MedImmune, Inc. (Nasdaq: MEDI) announced
that additional safety and efficacy data on the use of Synagis (palivizumab) for
the prevention of serious respiratory syncytial virus (RSV) disease in pediatric
patients at high risk for RSV disease was presented at the Second World Congress
of Pediatric Infectious Diseases in Manila, November 2-6, 1999 (see full
prescribing information at www.medimmune.com/medimmune/products/synagispi.htm).
Data presented included the clinical outcomes of patients receiving Synagis
during the 1998/1999 RSV season, the drug's first season of general use in the
United States. Also presented were data from an Expanded Access Study in 15
countries where Synagis was not yet available during the 1998/1999 season. All
data presented at the World Congress affirm the results observed in MedImmune's
pivotal Phase 3 trial (Impact-RSV), which demonstrated that Synagis is safe and
effective in reducing RSV hospitalizations in all defined population subgroups.
"We are obviously pleased with the results of these studies," commented Franklin
H. Top, Jr., M.D., MedImmune's executive vice president and medical director,
"since they indicate that Synagis is effective in actual clinical practice, just
as it was efficacious in clinical trials. Also, safety data from our compliance
program confirm in much larger numbers of children the excellent safety profile
seen in clinical trials. Both pediatricians and parents of children at risk of
RSV disease can have increased confidence of the safety and effectiveness of
Synagis as we enter its second season of clinical use."
First Year Experience with Synagis in the United States
- ---------------------------------------------------------
The abstract entitled "First Year Experience Using Synagis Palivizumab Humanized
Monoclonal Antibody for Protection From RSV Lower Respiratory Tract Infection,"
Alan Cohen, M.D., et al., and the Synagis Outcomes Survey Group, reports on two
surveys performed to evaluate the clinical effectiveness of Synagis during the
1998/1999 RSV season. The first survey involved a thorough chart review of 1,839
patients from nine U.S. sites, representing all patients given Synagis at each
site. All evaluated patients were <=35 weeks gestational age and received at
least one dose of Synagis between September 1998 and May 1999. The data showed
that the RSV hospitalization rate in all patients receiving Synagis was 2.3
percent. This compares favorably to RSV hospitalization rates of 4.8 percent and
10.6 percent for patients receiving Synagis and those receiving placebo,
respectively, in the IMpact-RSV trial. Only 0.5 percent of the patients
receiving Synagis spent any time in intensive care due to RSV disease.
The second set of data surveyed came from safety reports in MedImmune's
compliance program called the REACH Program (Registered) (RSV Education and
Compliance Helpline), which included 7,013 patients who received Synagis during
the 1998-1999 RSV season and whose parents were contacted on a regular basis to
monitor compliance with their physician's prescribing orders. Adverse events
reported in these children were similar to those identified in both the
treatment and placebo groups of the Impact-RSV trials. Only 1.5 percent of the
children enrolled in the REACH Program were reported to have been hospitalized
due to RSV infection.
Expanded Access Study in 1998/1999 in the Northern Hemisphere
- -------------------------------------------------------------
The abstract entitled "Palivizumab (Synagis)-Expanded Access Study in 1998-99
Northern Hemisphere," Barbara J. Law, M.D., et al., provides data from a Phase 4
study initiated during the 1998/1999 RSV season to collect additional safety
data in 15 countries where Synagis was not yet readily available. A total of 565
children were enrolled at 77 centers in this single-arm, open-labeled study.
Forty-one patients were hospitalized with respiratory illness during the study:
seven were RSV-positive, 20 were RSV-negative, and 14 were not tested for RSV.
If the 14 patients not tested for RSV were assumed to all be RSV positive, the
maximum RSV hospitalization rate would be 3.7 percent in this study, while the
actual confirmed RSV hospitalization rate was 1.2 percent. These results again
compare favorably to the 4.8 percent RSV hospitalization rate for patients
treated with Synagis in MedImmune's pivotal clinical trial.
The Expanded Access Study broadens the geographical region in which Synagis has
been evaluated. Twenty-five countries have approved Synagis for use in
preventing RSV infection in high-risk children. Applications for approval have
been submitted in 19 additional countries.
Synagis is a humanized monoclonal antibody used in the prevention of serious
lower respiratory tract disease caused by RSV in pediatric patients at high risk
of RSV disease, the most common cause of pneumonia and bronchiolitis in infants
and children. Synagis is the first monoclonal antibody to be licensed for any
infectious disease. It is administered by intramuscular injection once per month
during anticipated periods of RSV prevalence, which typically runs from October
through April in the United States, where there are over 300,000 infants at risk
of contracting the disease. In the United States, MedImmune co-promotes the
product with the Ross Products Division of Abbott Laboratories (NYSE:ABT).
Outside the U.S., Abbott International owns an exclusive license to market the
product.
MedImmune, Inc. is a biotechnology company located in Gaithersburg, Maryland
focused on developing and marketing products that address medical needs in areas
such as infectious disease, transplantation medicine, autoimmune disorders and
cancer. The company currently markets three products and has five 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.
SIGNATURES
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 hereunto duly authorized.
MEDIMMUNE, INC.
----------------
(Registrant)
November 8, 1999 ________________________________
David M. Mott, Vice Chairman and
Chief Financial Officer
