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: July 7, 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 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 July 6, 1999:
FOR IMMEDIATE RELEASE
Contacts:
William C. Roberts Len Lavenda
Investor and Media Relations Pasteur Merieux Connaught USA
MedImmune, Inc. 570-839-4446
301-417-0770 x358
http://www.medimmune.com
http://www.us.pmc-vacc.com
MEDIMMUNE AND PASTEUR MERIEUX CONNAUGHT REPORT PRESENTATION OF NEW DATA ON LYME
DISEASE VACCINE CANDIDATE AT INTERNATIONAL LYME MEETING
- - Synergy between Decorin Binding Protein A and Outer Surface Protein A Shown in
Mouse Model -
Gaithersburg, MD and Swiftwater, PA, July 6, 1999 -- MedImmune, Inc. (Nasdaq:
MEDI) and Pasteur Merieux Connaught, a wholly owned subsidiary of Rhone-Poulenc
S.A. (NYSE: RP), today announced the presentation of data showing that a
combination vaccine composed of decorin binding protein A (DbpA) and outer
surface protein A (OspA) is more efficacious in preventing infection by Borrelia
burgdorferi and related species in mice than vaccination with either immunogen
alone. B.burgdorferi is a bacterium which causes Lyme disease. The presentation
was given at the International Conference on Lyme Borreliosis and other Emerging
Tick-Borne Diseases in Munich, Germany. In these experiments, the combination
vaccine prevented infection in mice by genetically diverse strains of
B.burgdorferi. These data suggest that the addition of DbpA to an OspA vaccine
for Lyme disease might enhance the level of protection provided by vaccination
with OspA alone against infection by the Lyme disease-causing bacterium.
"Decorin Binding Protein has always shown promise as a second generation Lyme
disease vaccine candidate in that it actively targets the disease-causing
bacterium, B.burgdorferi, during the early stage of infection following the bite
of an infected tick," commented James Young, Ph.D., Executive Vice President of
Research and Development at MedImmune. "This apparent synergy with OspA may
allow use of a combination vaccine with a broader efficacy than a single antigen
vaccine."
The study, authored by Mark Hanson, Ph.D. et al., entitled "Evidence for Vaccine
Synergy Between Borrelia burgdorferi Decorin Binding Protein A (DbpA) and Outer
Surface Protein A (OspA) in the Mouse Model of Lyme Borreliosis," showed that
the mechanisms of immunoprophylaxis provided by DbpA and OspA may complement
each other when compared to immunoprophylaxis with either antigen alone. The
scientists compared the efficacy of the combination vaccine to the single
antigen vaccines in preventing infection after escalating challenge doses of
B.burgdorferi. The combination vaccine was shown to completely prevent infection
at all challenge doses. Additionally, very low doses of the combination vaccine
were more effective than higher doses of the single antigen vaccines. Finally,
the combination vaccine was shown to be more effective in preventing infection
after challenge with heterologous strains of B.burgdorferi, compared to either
single antigen vaccine.
"These experimental data are particularly exciting as the combination vaccine
demonstrates its ability to prevent infection with heterologous strains commonly
found outside the U.S.," added Alf Lindberg, Senior Vice President of Research
and Development at Pasteur Merieux Connaught. "This combination vaccine has the
potential to provide protection against strains found throughout the world and
may provide the basis for an improved and international Lyme vaccine."
DbpA was discovered by Magnus Hook, Ph.D. and Betty Guo at Texas A&M
University's Institute of Biosciences and Technology in Houston, Texas and
exclusively licensed to MedImmune. These scientists found that a protein
expressed by spirochetes which cause Lyme disease, including B.burgdorferi and
related species, could bind to a protein called "decorin" commonly found in
human skin and connective tissue. Hook and Guo determined the gene sequence
encoding the protein in 1995. Both groups found that animals immunized with DbpA
can be protected from challenge with the bacterium. These researchers have also
shown the ability of antibodies directed against DbpA to inhibit growth of
B.burgdorferi and related strains, including isolates not inhibited by
antibodies directed against OspA.
Lyme disease is the most common arthropod-borne disease in the United States.
Forty-eight states have reported cases of Lyme disease, with a reported annual
incidence of approximately 16,000 new cases nationwide. Lyme disease is also
reported in Europe, Japan, China and Russia. The disease is caused by a
bacterium known as B. burgdorferi and related species, and is transferred
through a tick, primarily Ixodes scapularis, most commonly found on the
white-footed mouse or deer in the northeastern U.S. When the tick feeds on a
human host, it can transmit bacteria to the host, thereby beginning a Lyme
disease infection.
Following a tick bite, an infected person will often develop a circular rash
with a bulls-eye pattern. Weeks to months later, this rash may be followed by
neurological, cardiac and joint abnormalities, malaise and general flu-like
symptoms. Early treatment with antibiotics is generally most effective; however,
some infections, particularly if diagnosed late, have proven to be resistant to
antibiotic therapy. Difficulties with early diagnosis as well as the occurrence
of serious treatment-resistant infections emphasize the need for safe and
effective vaccines against Lyme disease.
In December 1998, MedImmune and Pasteur Merieux Connaught entered into a license
agreement to develop a second generation vaccine for the prevention of Lyme
disease. The first generation vaccine candidate of Pasteur Merieux Connaught,
based on outer surface protein A found on the organism which causes Lyme
disease, has completed a Phase 3 clinical trial. Pursuant to its agreement with
MedImmune, Pasteur Merieux Connaught gained exclusive worldwide rights to
MedImmune's technology related to decorin binding protein, also found on the
organism which causes Lyme disease. Pasteur Merieux Connaught intends to use
DbpA for the development of European and possibly improved U.S., vaccines for
the prevention of Lyme disease.
MedImmune, a biotechnology company located in Gaithersburg, Maryland, is 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 Synagis (palivizumab), RespiGam (Respiratory
Syncytial Virus Immune Globulin Intravenous (Human)), and CytoGam
(Cytomegalovirus Immune Globulin Intravenous (Human)) through its hospital-based
sales force and has five new product candidates in clinical trials.
Pasteur Merieux Connaught (Rhone-Poulenc Group) is the world's largest vaccine
company with the broadest range of products. The company produces more than one
billion doses of vaccines every year to immunize 400 million people worldwide.
Rhone-Poulenc S.A., headquartered in Paris, France, is a leading life sciences
company, growing through innovations in human, plant and animal health and
through its specialty chemicals subsidiary, Rhodia. With sales in 1998 of $14.7
billion, the company employs 65,000 people in 160 countries worldwide.
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 both
companies' 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) July 6, 1999
