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: September 30, 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 September 28, 1998:
NEW DATA FROM MEDIMMUNE CLINICAL TRIALS PRESENTED AT ICAAC
- - Results From Trials Evaluating HPV Vaccine and Synagis for Treatment
of RSV -
Gaithersburg, MD, September 28, 1998 -- MedImmune (Nasdaq:MEDI) today
reported new clinical data from two of the Company's programs: MEDI-
501, a candidate vaccine for human papillomavirus (HPV), and Synagis
(palivizumab), a monoclonal antibody for respiratory syncytial virus
(RSV). Data were presented by investigators at the 38th Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San
Diego, California.
In a clinical trial conducted to evaluate the safety and immunogenicity
of MEDI-501, recipients developed dose-related antibody responses to
the vaccine and the product was believed to be safe and generally well-
tolerated. MEDI-501 is a virus-like particle-based vaccine candidate
for HPV type 11, a common cause of genital warts. HPVs cause genital
warts and cervical cancer.
In a second set of clinical trials conducted to evaluate Synagis for
treating and preventing RSV in adult recipients of hematopoietic stem
cell transplants (HSCTs), Synagis was maintained in the blood above
concentrations believed to provide protection against severe RSV
disease. Additionally, Synagis was believed to be safe and generally
well-tolerated in these treatment settings. Synagis is a humanized
monoclonal antibody currently marketed in the United States 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). RSV is the most common cause
of pneumonia and bronchiolitis in infancy and early childhood. RSV can
also cause life-threatening pneumonia in HSCT and other
immunocompromised patients.
"The data presented at ICAAC are an important foundation for our
understanding of virus-like particle-based HPV vaccines and Synagis in
these medical settings, and support moving these programs to the next
level of evaluation," commented Edward Connor, M.D., Vice President,
Clinical Research at MedImmune. "To date we have studied Synagis
primarily for prevention of serious RSV disease in infants. The
results presented at ICAAC are a first look at Synagis in the treatment
of RSV in hematopoietic stem cell transplant patients. The mortality
rate of HSCT recipients who develop RSV pneumonia is reported to be
over 70 percent. In this small, uncontrolled treatment study reported
at ICAAC, the mortality rate of 17 percent appeared lower than
historical data. We are planning in the near future to conduct a
controlled trial to assess the efficacy of Synagis in this patient
population."
In the first presentation abstract titled "A Phase I Study of a
Recombinant Virus Like Particle Vaccine Against Human Papillomavirus
Type 11 in Healthy Adult Volunteers," the safety and immunogenicity of
MEDI-501 was evaluated in a double-blind, randomized, dose-escalating,
adjuvant-controlled trial. These data were presented at ICAAC by
Richard C. Reichman, M.D., Professor of Medicine, Microbiology and
Immunology at the University of Rochester Medical Center and the
Principal Investigator of the vaccine trial. Sixty-five healthy
volunteers received an initial injection and two booster injections of
either alum-adjuvanted vaccine at various escalating doses or alum
alone. Vaccine injections were believed to be generally well-
tolerated. The most common adverse events within four days after an
injection were those commonly seen with alum-adjuvanted vaccines,
including pain at the injection site, headache and fatigue. HPV
antibodies were elevated in all patients after each of the three
injections of MEDI-501 in the dosing regimen. Antibodies that could
neutralize HPV were induced in nearly all volunteers at the higher
doses and 100 percent of the patients receiving all three injections at
the highest dose (n=10) developed elevated levels of antibodies that
could neutralize HPV.
HPVs are responsible for the development of genital warts and cervical
cancer. There are over 75 different types of HPV associated with a
variety of clinical disorders ranging from benign lesions to
potentially lethal cancers. Four types of HPV cause the majority of
genital warts and cervical cancer cases: HPV-6 and HPV-11 (genital
warts) and HPV-16 and HPV-18 (cervical cancer). There are currently no
vaccines to prevent these common sexually transmitted diseases that
affect 24 to 40 million men and women in the United States.
MedImmune's strategy for vaccine development, including MEDI-501 (HPV-
11), relies on a virus-like particle (VLP) technology for producing a
structurally identical, non-infectious form of the virus in vitro. The
potential effectiveness of a VLP vaccine candidate has been
demonstrated utilizing an animal model for papillomavirus infection. In
late 1997, MedImmune and SmithKline Beecham (SB) announced the
formation of an exclusive worldwide alliance to develop HPV vaccine
candidates.
In the second presentation abstract titled "Phase I Evaluation of a RSV-
Specific Humanized Monoclonal Antibody (MEDI-493) After Hematopoietic
Stem Cell Transplantation (HSCT)," the safety and pharmacokinetics of
Synagis (palivizumab; formerly identified as MEDI-493) were evaluated
in two studies. These data were presented at ICAAC by Michael J.
Boeckh, M.D., Assistant Professor, University of Washington Department
of Medicine and Associate in Clinical Research at the Fred Hutchinson
Cancer Research Center in Seattle, Washington where the trials were
conducted. In both studies, patients received a single 15 mg/kg
intravenous dose of Synagis. In the first study, patients at risk for
RSV infection but without active infection, received Synagis
prophylactically (n=6). Synagis blood serum levels of greater than 40
ug/ml, believed to be protective of RSV, were maintained for 21 days in
five patients. In the second study, patients with active RSV
infections (n=15) including upper respiratory infections (URI; n=3) or
RSV pneumonia (n=12) were treated with ribavirin and Synagis. All
three patients with URI and 10 of 12 patients with RSV pneumonia
survived the 28 day study period. Synagis in these studies appeared to
be safe and generally well-tolerated.
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 benign chest 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. Each year in the
United States, more than 90,000 infants are hospitalized with RSV
disease. The mortality rate of hospitalized infants with RSV infection
of the lower respiratory tract is about 2 percent. There are
approximately 325,000 infants at high risk of acquiring severe RSV
disease in the U.S. Synagis is a humanized monoclonal antibody
currently marketed in the United States for the prevention of serious
lower respiratory tract disease caused by respiratory syncytial virus
(RSV) in pediatric patients at high risk of RSV disease. 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.
RSV disease is a serious risk in HSCT recipients. The bone marrow produces all
blood cells, including red cells, white cells and platelets. When cancer
patients receive high-dose chemotherapy or radiation to eradicate tumors or
blood-borne cancers, bone marrow cells are also destroyed, leaving the
individual susceptible to infections and blood clotting problems. Hematopoietic
stem cell transplantation is often performed to restore the ability of the body
to produce blood. Hematopoietic stem cells, the precursors of all blood cells,
comprise approximately 1 in every 10,000 bone marrow cells. There are many
different sources of hematopoietic stem cells for transplantation. Whole
donated bone marrow is most often used as a source of hematopoietic stem cells,
especially with allogeneic (non-self) donors. This procedure is commonly known
as bone marrow transplantation (BMT). Other growing sources of hematopoietic
stem cells include peripheral blood stem cells (PBSCs) isolated directly from
the blood, purified bone marrow and umbilical cord blood. There are
approximately 30,000 HSCT procedures each year worldwide. Because of the
extreme state of immunosuppression these patients experience in the months
following an HSCT procedure, individuals can develop severe RSV disease if
exposed to RSV during that period. The mortality rate of HSCT recipients who
develop RSV pneumonia is reported to be over 70 percent.
MedImmune 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 markets 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 contains, 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.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) September 30, 1998
