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: March 20, 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 March 20, 1997.
MEDIMMUNE REPORTS RESULTS FROM DOUBLE-BLIND, PLACEBO-CONTROLLED,
PHASE 1/2 CLINICAL TRIAL OF MEDI-493
Gaithersburg, MD, March 20, 1997 -- MedImmune, Inc. (Nasdaq:MEDI)
today released results from a double-blind, placebo-controlled, dose-
escalating, multi-center Phase 1/2 trial evaluating important safety
and pharmacological properties of MEDI-493 in children. MEDI-493 is a
humanized monoclonal antibody being developed for use in combating
serious RSV disease in children.
The Phase 1/2 trial was conducted at 10 medical centers in the United
States. A total of 62 infants with a history of prematurity (i.e.,
less than or equal to 35 weeks gestation) or a lung condition called
bronchopulmonary dysplasia (BPD) were randomized to receive placebo
(n=20) or MEDI-493 at 3 mg/kg (n=10), 10 mg/kg (n=10) or 15 mg/kg
(n=22) once per month intravenously for up to 5 doses. The primary
objectives of this study were to assess the safety, tolerance,
immunogenicity and pharmacokinetics of MEDI-493 in these high-risk
infants.
There were no significant differences in adverse events or
immunogenicity observed between patients receiving placebo or MEDI-493,
suggesting that MEDI-493 was generally safe and well-tolerated. The
average half-life observed was approximately 20 days, similar to that
previously demonstrated in Phase 1 studies in healthy adult volunteers
further supporting monthly dosing. Doses of 10 and 15 mg/kg maintained
serum levels exceeding the target range of 25 to 30 ug/ml throughout
the dosing interval. This level has been associated with a 99 percent
reduction of RSV in the lungs of cotton rats, the same target used in
the development of RespiGam (Respiratory Syncytial Virus Immune
Globulin Intravenous (Human)) for the same indication. Certain
additional clinical parameters were monitored for safety purposes such
as incidence of all respiratory hospitalizations (3/20 in the placebo
group and 5/10, 1/10 and 3/22 in groups receiving 3, 10 and 15 mg/kg,
respectively) and RSV-associated hospitalizations (2/20 in the placebo
group and 2/10, 0/10 and 0/22 in groups receiving 3, 10 and 15 mg/kg,
respectively). No statistically significant differences were observed
with any of these clinical parameters.
"Results from this first trial of MEDI-493 in infants add to the safety
and pharmacological experience of the previously reported Phase 1
studies conducted in healthy adult volunteers," commented David M.
Mott, President and Chief Operating Officer. "We have completed three
additional Phase 1/2 trials of MEDI-493 in infants and are now
completing the analysis of data from those studies. We expect to
report results from each of those studies over the next few months.
Progress also continues on our Phase 3 trial, IMpact-RSV, evaluating
MEDI-493 for prevention of serious RSV disease in high-risk infants.
We expect to report results from IMpact-RSV in third quarter 1997."
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 a chronic
lung condition called 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.
MedImmune currently markets RespiGam for the prevention of serious RSV
disease in certain high-risk infants. Unlike RespiGam, which is given
by a two to four hour intravenous infusion, MEDI-493 has been given
more rapidly by infusion or by intramuscular injection. Consequently,
if successfully developed, MEDI-493 has the potential to enhance
patient care, reduce costs associated with drug administration and
improve convenience for parents, physicians and nurses. Taken
together, these benefits provide the potential to reach a broader
population of children with MEDI-493 than with RespiGam.
MEDI-493, a humanized monoclonal antibody, binds to a protein on the
surface of RSV which is necessary for the virus to infect cells. In
laboratory experiments, MEDI-493 has been shown to neutralize all
strains of RSV tested and to prevent infection in cotton rats. Studies
in cotton rats, widely thought to be the best model of RSV infection in
humans, have shown that MEDI-493 is 50 to 100 times more potent than
RespiGam allowing the same anti-viral effect to be delivered in a much
smaller volume. To date, MedImmune has retained exclusive worldwide
marketing and manufacturing rights to MEDI-493.
The IMpact-RSV trial is a double-blind, placebo-controlled, Phase 3
trial being conducted at 139 medical centers in the United States,
Canada and the United Kingdom. IMpact-RSV is designed to evaluate the
safety and efficacy of MEDI-493 for the prevention of serious RSV
disease in high-risk infants. A total of 1,502 children were randomized
to receive MEDI-493 (15mg/kg) or placebo by intramuscular injection
approximately every 30 days from November to April for a total of up to
five injections. The primary endpoint of the trial is the incidence of
RSV hospitalization (confirmed by RSV antigen test).
RespiGam is a polyclonal antibody licensed by the FDA in January 1996
for prevention of serious lower respiratory tract infection caused by
RSV in children under 24 months of age with BPD or a history of
premature birth (i.e., less than or equal to 35 weeks gestation).
RespiGam is the only product demonstrated to be safe and effective in
reducing incidence and duration of RSV hospitalization and severity of
RSV illness in these high-risk infants (Please see full prescribing
information). RespiGam is marketed in the United States by MedImmune
together with the Wyeth-Lederle Vaccines and Pediatrics sales force of
Wyeth-Ayerst Laboratories (a division of American Home Products
Corporation; NYSE:AHP). MedImmune has established a collaboration with
Baxter Healthcare Corporation (a division of Baxter International;
NYSE:BAX) for commercialization of RespiGam outside of North America.
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 six
new product candidates in clinical trials. RespiGam is manufactured by
Massachusetts Public Health Biologic Laboratories. 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 the safety and effectiveness of MEDI-493 have not been
demonstrated and the outcome of the IMpact-RSV trial cannot be
predicted. Accordingly, there can be no assurance that MEDI-493 will
be licensed for marketing by regulatory authorities. Substantial
uncertainty remains until the trial is concluded and data are known.
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: March 20, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
