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 10, 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 10, 1997.
MEDIMMUNE REPORTS FIRST MEDI-493 CLINICAL TRIAL RESULTS
Gaithersburg, MD, March 10, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
released the first results from clinical trials evaluating important
safety and pharmacological properties of MEDI-493. MEDI-493 is a
humanized monoclonal antibody being developed for use in combating
respiratory syncytial virus (RSV) disease in children. To date, nine
Phase 1 and Phase 1/2 clinical studies of MEDI-493 have been completed in
six countries involving approximately 300 patients. Data released today
were compiled from the first four Phase 1 clinical studies of MEDI-493 in
38 healthy adult volunteers.
"Results from MedImmune's initial clinical studies of MEDI-493 address
four key issues:
1) Safety -- in these trials MEDI-493 was generally safe and well
tolerated;
2) Immunogenicity -- no significant immune responses against the antibody
itself were observed;
3) Half-life -- the half life observed supports monthly dosing of the
antibody, and;
4) Dose selection -- blood levels of MEDI-493 at a dose of 15mg/kg
exceeded those predicted to protect against serious RSV disease,"
commented Franklin H. Top, Jr., M.D, Executive Vice President and Medical
Director.
"With the data from the first four Phase 1 trials in hand, MedImmune
conducted an additional five Phase 1/2 studies in infants during the fall
of 1995 and throughout 1996. These subsequent studies have all been
completed, results are being analyzed and will be reported over the next
several months," added Dr. Top. "Two additional trials are currently
underway, a Phase 2 study evaluating MEDI-493 in the treatment of children
hospitalized with RSV disease and a Phase 3 trial (IMpact-RSV) evaluating
MEDI-493 for prevention of serious RSV disease in high-risk infants. We
expect to report results from both of these trials in third quarter 1997."
In the four Phase 1 studies reported here, MEDI-493 was well tolerated at
doses ranging from 1 to 15 mg/kg with no drug-related serious adverse
events. Only low level and transient immune responses to MEDI-493 were
observed in a small number of subjects. The duration of the antibody in
the bloodstream (half-life ranging from 13 to 26 days) was similar to that
of natural human antibodies which the Company believes makes MEDI-493
appropriate for monthly dosing. Data suggested that a 15 mg/kg dose of
MEDI-493 (the dose chosen for IMpact-RSV) resulted in blood levels that
exceeded those associated with a 99 percent reduction of RSV in the lungs
of cotton rats. MedImmune scientists have targeted the 99 percent level
of RSV reduction in the cotton rat model as an important benchmark
required to prevent serious RSV disease in children. This benchmark was
used to select the dose for RespiGam (Respiratory Syncytial Virus Immune
Globulin Intravenous (Human)) which was shown in clinical studies to
reduce the incidence of RSV-associated hospitalization in certain high-
risk infants by 41% to 62%.
Both intravenous and intramuscular routes of administration as well as
liquid and lyophilized formulations were assessed. Within seven days
after the first intramuscular dose of MEDI-493, blood levels increased to
those levels attained by intravenous dosing and remained approximately
superimposable until the next dose. With intramuscular doses given
monthly, blood levels of MEDI-493 were maintained above the Company's
benchmark for RSV protection. The Company believes these findings support
administration of MEDI-493 by either route. No significant differences in
the safety profile of MEDI-493 were observed between different
formulations and routes of administration.
"If successfully developed and commercialized, MEDI-493 has the potential
to significantly expand the RSV market from that addressed by RespiGam,
our first product for RSV disease," said Wayne T. Hockmeyer, Ph.D.,
Chairman and Chief Executive Officer. "Most importantly, because of the
greater potency of MEDI-493 and the resulting ease of administration by
intramuscular injection, MEDI-493 has the potential to enhance patient
care, reduce costs associated with drug administration and improve
convenience for parents, physicians and nurses."
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.
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. This
dosing advantage allows MEDI-493 to be given more rapidly by infusion or
by intramuscular injection rather than by the two to four hour intravenous
infusion required to administer RespiGam. 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 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 being
marketed in the United States by MedImmune in partnership 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. 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 10, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
