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: June 20, 1996
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 51-1555759
(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
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MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained on the following
press releases dated June 20, 1996.
MEDIMMUNE ANNOUNCES PROPOSED
PRIVATE OFFERING OF CONVERTIBLE DEBT
Gaithersburg, MD, June 20, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced it that it is proposing to make a private offering
of $60 million aggregate principal amount of convertible
subordinated notes due 2003. The notes will be unsecured
obligations, convertible into MedImmune common stock and
subordinated to all present and future senior indebtedness of
MedImmune.
MedImmune intends to use the net proceeds of the offering for
general corporate purposes, including the funding of certain capital
expenditures associated with construction of a manufacturing
facility.
The notes and the underlying common stock have not been registered
under the Securities Act of 1933 and may not be offered or sold in
the United States absent registration or an applicable exemption
from the registration requirements of the Securities Act and
applicable state securities laws.
The notes will be offered within the United States only to
"qualified institutional buyers" (as defined in Rule 144A under the
Securities Act) and institutional "accredited investors" (as defined
in Rule 501 under the Securities Act) and outside the United States
to certain persons in reliance upon Regulation S under the
Securities Act.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy the notes or the underlying common
stock.
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MEDIMMUNE REPORTS DATA ON NEW LYME DISEASE VACCINE CANDIDATE AT
INTERNATIONAL LYME MEETING
-- Antibodies to Newly Discovered Decorin Binding Protein Prevent
Infection In Animals --
Gaithersburg, MD, June 20, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today reported data being presented at the Seventh International
Congress on Lyme Borreliosis in San Francisco, California showing
that animals are protected from infection caused by the Lyme disease-
causing bacterium Borrelia burgdorferi by antibodies to a newly
identified protein. This protein, called decorin binding protein
(DBP), was recently discovered in B. burgdorferi by Texas A&M
scientists and licensed exclusively to MedImmune. Data reported at
the meeting suggest that as a Lyme disease vaccine candidate, DBP
may provide advantages over outer surface protein A (OspA), another
candidate currently being evaluated by others in humans. Unlike
antibodies to OspA, DBP antibodies can be given to mice four days
after infections and still clear the bacterium from animals. This
may allow a significantly greater window of opportunity for a
protective immune response to clear infection. DBP is the only
protein identified from B. burgdorferi to date for which this
effect has been demonstrated. In addition, antibodies from animals
immunized with DBP inhibited growth of many strains of the Lyme
disease-causing bacteria not inhibited by OspA antibodies, including
some species of Lyme bacteria commonly found outside the United
States. These results suggest that DBP may provide an improved Lyme
disease vaccine candidate or, alternately, a supplement to the
vaccine candidates currently in development.
"Decorin binding protein has clearly emerged as a promising second-
generation vaccine antigen targeting Lyme disease-causing
spirochetes during the early stage of infection," said Stephen
Barthold, D.V.M., Ph.D., Professor of Comparative Medicine at Yale
University School of Medicine.
Decorin binding protein (DBP) 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. These scientists found
that a protein isolated from B. burgdorferi bound to a protein
called "decorin" commonly found in human skin and cartilage tissue.
Hook and Guo determined the gene sequence encoding the protein in
1995.
Together with a group of researchers at MedImmune led by Mark
Hanson, Ph.D., Director of Molecular Microbiology, these scientists
determined that DBP is present in all known species of the Lyme
disease-causing bacterium and that animals immunized with DBP are
protected from challenge with B. burgdorferi.
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The scientists also evaluated the ability of DBP antibodies to
inhibit growth of a variety of worldwide Lyme disease bacterium
strains. OspA antibodies alone inhibited growth of 82% of U.S.
isolates and only 14% of isolates commonly found outside the U.S.
In the same experiments, DBP antibodies inhibited all U.S. isolates
not inhibited by OspA antibodies, and an additional 40% to 50% of
isolates commonly found outside of the U.S. MedImmune has initiated
pre-clinical development of a Lyme disease vaccine candidate based
on DBP and, if additional studies are promising, plans to request
approval from the FDA to commence human clinical trials in 1997.
"Decorin binding protein is the first Lyme disease vaccine candidate
discovered from the Lyme disease-causing bacterium that has the
potential to be relevant for worldwide use and induces antibodies
which are protective days after initial infection in our animal
models," added Dr. Hanson. "If these qualities are borne-out by
further studies, DBP may provide the basis for an improved Lyme
disease vaccine candidate."
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 reported incidence of
approximately 13,000 new cases. Lyme disease is also reported in
Europe, Japan, China, Russia and Australia. The disease is caused
by a bacterium known as B. burgdorferi and is transmitted through a
tick, Ixodes scapularis, which is most commonly found on the white-
footed mouse or deer. When the tick feeds on a human host, it can
transmit the 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 the 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 a safe and effective vaccine against Lyme
disease.
Scientists in a variety of laboratories have found recently that the
protein used in vaccine candidates currently in human clinical
trials, OspA, may be expressed on the surface of B. burgdorferi only
when the bacterium is in the tick. According to these scientists,
OspA is lost from the surface of the bacterium as the tick feeds on
its human host and injects the bacterium into the human. This
unusual effect suggests that an effective vaccine based on OspA must
be able to clear infection while the tick is feeding on the human,
or shortly thereafter. A vaccine which can clear the bacterium many
days after initial infection may provide significant advantages. In
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addition, OspA is variable among many strains outside of the United
States. A protein which is found on many worldwide strains of B.
burgdorferi may also provide significant advantages.
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 products in clinical trials. MedImmune is
located in Gaithersburg, MD.
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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: June 20, 1996 s/David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
