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 16, 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 14, 1998:
MEDIMMUNE AND CHIRON ENTER AGREEMENT
ON VACCINE ADJUVANT TECHNOLOGY
- Chiron to Provide MF59 for Two of MedImmune's Programs -
Gaithersburg, MD and Emeryville, CA, September 14, 1998 -- MedImmune, Inc.
(Nasdaq:MEDI) and Chiron (Nasdaq:CHIR) today announced they have entered into an
agreement on vaccine adjuvant technology developed by Chiron. Under the terms
of the agreement, Chiron will supply MedImmune with MF59, a proprietary vaccine
adjuvant, for two of MedImmune's vaccine development programs, parvovirus B19
and Escherichia coli (E. coli). Chiron will receive an up-front payment, as
well as additional payments if certain milestones are achieved, and would
receive royalties if and when products are commercialized. MF59 has been
evaluated by Chiron in clinical trials involving over 15,000 people. It was
shown to enhance the immune response to certain antigens and was generally safe
and well-tolerated. In 1997, Chiron received marketing authorization in Italy
for its MF59-adjuvanted influenza vaccine, FLUAD (registered trademark).
MedImmune's parvovirus B19 vaccine candidate has completed a Phase 1 clinical
trial, and its E. coli vaccine candidate for urinary tract infections is
expected to enter the clinic in 1999.
"MF59 has the advantage of being one of the most extensively tested
investigational vaccine adjuvants in human clinical trials," commented James F.
Young, Ph.D., Sr. Vice President, Research and Development at MedImmune. "We've
seen exceptional immune responses to our parvovirus B19 and E. coli vaccine
candidates when formulated with MF59 in animal studies compared to other
available adjuvants. We applaud Chiron's efforts to commercialize an improved
vaccine adjuvant and look forward to working with them toward this goal."
"Chiron has invested substantially in the development of MF59," said Leander
Lauffer, Ph.D., Vice President, Business Development of Chiron's Vaccines
division. "We recognized the need for novel, improved adjuvants, and we are
gratified to see our efforts validated by MedImmune's decision to use MF59 as an
adjuvant for two of its most exciting vaccine candidates."
MedImmune's E. coli vaccine is being developed to prevent urinary tract
infections (UTIs). The bacteria E. coli is responsible for approximately 85% of
UTIs in women. MedImmune plans to begin clinical trials with its E. coli
vaccine candidate adjuvanted with MF59 in late 1999. Currently there are no
vaccines to prevent E. coli infections or UTIs. UTIs are a significant medical
problem and one of the most common disorders prompting medical attention in
otherwise healthy women and children. It is estimated that by age 30 roughly 50
percent of women have had at least one infection and 2 to 10 percent are
affected by recurrent infections. In April 1997, MedImmune published data in
Science describing successful studies in mice with its E. coli vaccine. More
recently, MedImmune has completed studies in monkeys with its E. coli vaccine
formulated with MF59 that further support its potential to prevent UTIs.
MedImmune's B19 parvovirus vaccine candidate, MEDI-491, was developed by
MedImmune and the National Heart, Lung, and Blood Institute under a Cooperative
Research and Development Agreement (CRADA). MedImmune has completed a Phase 1
trial evaluating the safety and immunogenicity of MEDI-491 with aluminum
hydroxide as an adjuvant and plans to commence additional clinical testing
during 1999 with MF59. Results from the initial study suggested that MEDI-491
was safe and generally well-tolerated, and that antibodies to B19 parvovirus
were induced. Discovered in 1975, B19 parvovirus has been linked to a number of
serious conditions including miscarriages in pregnant women, life-threatening
sudden reduction of red blood cells (transient aplastic crisis) in sickle cell
anemia patients, chronic anemia in AIDS and chemotherapy patients, and
persistent or acute arthritis in some adults. There are no agents available for
the prevention of B19 parvovirus infection. MedImmune believes a successful B19
parvovirus vaccine could be used both to immunize women entering their child-
bearing years to protect them from experiencing B19 parvovirus-induced
miscarriages and to vaccinate children with sickle cell anemia to protect them
against transient aplastic crisis.
Adjuvants are materials, such as aluminum hydroxide (alum), added to vaccine
preparations to improve the immune response to the vaccine. Using the proper
adjuvant is believed to be crucial for successful vaccine development. Alum is
currently the only vaccine adjuvant licensed for marketing in the United States.
While it has a good safety record, it is a relatively weak adjuvant. Chiron
developed the more potent MF59, an oil-in-water emulsion of the metabolizable
oil squalene and two surfactants, polyoxyethylene sorbitan monooleate (Tween 80)
and sorbitan trioleate (Span 85). An extensive clinical and safety database was
generated in numerous clinical studies conducted by Chiron. FLUAD (registered
trademark), Chiron's MF59-adjuvanted influenza subunit vaccine, was launched in
Italy last year for use in the elderly and other populations of adults at
increased risk of complications with influenza. Chiron is currently testing
MF59 with several vaccine candidate antigens.
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 markets three products through its hospital
- -based sales force and has four new product candidates in clinical trials.
MedImmune is located in Gaithersburg, MD.
Chiron Corporation, headquartered in Emeryville, California, is a leading
biotechnology company that participates in three global healthcare markets:
diagnostics, therapeutics and vaccines. Chiron also conducts research and
development in the fields of biological proteins, gene therapy and combinatorial
chemistry.
This announcement may contain, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties. Such
statements reflect both companies' 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. MedImmune separately cautions that RSV disease occurs
primarily during the winter months; the Company believes its operating results
will reflect that seasonality for the foreseeable future.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) September 16, 1998
