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: December 3, 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 December 2, 1998:
MEDIMMUNE AND PASTEUR MERIEUX CONNAUGHT ENTER
AGREEMENT TO DEVELOP SECOND GENERATION VACCINE FOR LYME DISEASE
Gaithersburg, MD and Swiftwater, PA, December 2, 1998 -- MedImmune, Inc.
(Nasdaq: MEDI) and Pasteur Merieux Connaught, a wholly owned subsidiary of Rhone
Poulenc S.A. (NYSE: RP), today announced that they have 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 a protein known as outer surface protein A ("OspA") found on the
organism which causes Lyme disease, has completed a Phase 3 clinical trial.
Pursuant to its agreement with MedImmune, Pasteur Merieux Connaught has gained
exclusive worldwide rights to MedImmune's technology related to a protein known
as decorin binding protein ("DbpA"), 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 would receive milestone payments and royalties on sales of
any vaccine incorporating DbpA.
"Pasteur Merieux Connaught's leadership position in developing a vaccine against
Lyme disease makes them an ideal partner for MedImmune," said Wayne T.
Hockmeyer, Ph.D., Chairman and Chief Executive Officer of MedImmune. "The work
Pasteur Merieux Connaught has already done in developing an OspA-based vaccine
against Lyme disease is an important advance for those individuals living in
endemic areas for this disease. We are excited about the opportunity to combine
our own technology with that of Pasteur Merieux Connaught to potentially provide
broader and more long lasting protection against Lyme disease than that able to
be provided by an OspA-based vaccine alone."
"We believe that MedImmune's technology in this area is complementary to our own
and look forward to building on the long standing relationship between our
companies," commented David J. Williams, President and Chief Operating Officer
of Pasteur Merieux Connaught. "The addition of DbpA to our portfolio will help
strengthen our position in Lyme disease vaccines," he added.
DbpA was discovered in 1993 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 Borrelia
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. Subsequently, a second decorin
binding protein, DbpB, was identified by Dr. Mark Hanson and colleagues at
MedImmune in collaboration with the scientists at Texas A&M University. 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 an annual
nationwide incidence of approximately 16,000 new cases. 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 of the genus, 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.
MedImmune, located in Gaithersburg, Maryland, 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.
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 1997 of $15
billion, the company employs 68,000 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) December 3, 1998