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 6, 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 and RespiGam are registered trademarks 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 May 6, 1997.
MEDIMMUNE REPORTS FOURTH SET OF CLINICAL RESULTS EVALUATING MEDI-493
- -- Presentations at The Society for Pediatric Research Annual Meeting --
Gaithersburg, MD, May 6, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
released its fourth set of results from a series of recently completed
clinical studies evaluating MEDI-493, a humanized monoclonal antibody
being developed for prevention of serious disease caused by respiratory
syncytial virus (RSV). RSV is the leading cause of pneumonia and
bronchiolitis in infants and young children. In a dose-escalating,
multi-center Phase 1/2 trial, known as CP012, MedImmune evaluated the
safety, tolerance and pharmacokinetics of MEDI-493 in infants. MEDI-
493 was found to be generally safe and well-tolerated and blood levels
of MEDI-493 following administration of the 15 mg/kg dose were
consistent with those seen in previously reported Phase 1/2 trials.
Each of the Phase 1 and Phase 1/2 trials evaluating MEDI-493 for
prevention of serious RSV disease in high risk infants which has been
completed to date is summarized below. The Company expects to release
results from an ongoing Phase 3 trial (IMpact-RSV) in the third quarter
1997. Data from specific clinical and pre-clinical studies of MEDI-493
are being presented today by Dr. K.N. Siva Subramanian, of Georgetown
University Medical Center, and Dr. Syd Johnson, of MedImmune, at The
Society for Pediatric Research meeting in Washington, D.C.
"The CP012 trial is the final RSV prevention study with MEDI-493 to be
completed prior to the conclusion of our Phase 3 trial, IMpact-RSV,"
commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive
Officer. "We are grateful for the assistance and cooperation we have
received from the many physicians, nurses, infants and parents who have
been involved in the extensive Phase 1/2 program we have conducted
during the past two and one-half years. We have now completed patient
dosing in the Phase 3 trial and expect to release results from this
study during the summer."
CP012 was conducted at seven medical centers in South Africa, Australia
and New Zealand. A total of 59 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 assigned to receive
monthly doses of MEDI-493 at 5 mg/kg (n=10) or 15 mg/kg (n=49) for up
to 5 doses.
The table below summarizes certain information about each of the RSV
prevention trials with MEDI-493 completed to date.
<TABLE>
<S> <C> <C> <C>
Protocol Design Phase Patients
----------------------------------------------------
MAb-9401a Open-Label 1 4 Healthy
(IV) Adult
Volunteers
MAb-9401b Open-Label, Dose 1 12 Healthy
(IV) Escalation Adult
Volunteers
MAb-9401c Open-Label, Dose 1 12 Healthy
(IV) Escalation Adult
Volunteers
CP007 (IM) Open-Label 1 4 Healthy
Adult
Volunteers
CP017 (IV) Open-Label, 1 6 Healthy
Lyophilized Product Adult
Volunteers
CP005 (IV) Double-Blind, 1/2 62 High-Risk
Placebo-Controlled, Infants
Dose Escalation
CP011 (IM) Open-Label, Dose 1/2 65 High-Risk
Escalation Infants
CP012 (IM) Open-Label, Dose 1/2 59 High-Risk
Escalation Infants
IV = Intravenous; IM = Intramuscular
</TABLE>
The primary objective of these studies was to evaluate the safety of
MEDI-493. In each of the trials, individuals were monitored carefully
for evidence of toxicity by assessing adverse events, immunogenicity
and clinical laboratory parameters. MEDI-493 was generally safe and
well-tolerated in all of these studies. As an additional assessment of
the safety of MEDI-493 in the pediatric trials, we looked for
exacerbation of RSV disease by monitoring RSV hospitalization rates.
The table below summarizes the incidence of RSV hospitalization by dose
group. The 15 mg/kg dose was selected for the Phase 3 IMpact-RSV trial
and the primary endpoint in that study is the incidence of RSV
hospitalization.
RSV Hospitalizations
<TABLE>
<S> <C> <C> <C> <C> <C>
Protocol Placebo 3 5 10 15
mg/kg mg/kg mg/kg mg/kg
----------------------------------------------------
CP005 2/20 2/10 -- 0/10 0/22
CP011 -- -- 2/11 0/6 0/48
CP012 -- -- 1/10 -- 0/49
Total 2/20 2/10 3/21 0/16 0/119
</TABLE>
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 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 (Respiratory Syncytial Virus
Immune Globulin Intravenous (Human)) for the prevention of serious RSV
disease in certain high-risk infants (please see full prescribing
information). Unlike RespiGam, which is given by a two to four hour
intravenous infusion, MEDI-493 has been administered in a shorter
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.
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. 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 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.
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: May 6, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
