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 26, 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
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained on the following
press release dated June 26, 1996.
MEDIMMUNE IN-LICENSES KEY HUMAN PAPILLOMAVIRUS VACCINE INTELLECTUAL
PROPERTY FROM GERMAN CANCER RESEARCH CENTER
Gaithersburg, MD, June 26, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced it has signed a worldwide, exclusive, royalty-
bearing licensing agreement with the German Cancer Research Center
(Deutsches Krebsforschungszentrum or DKFZ), to obtain rights to key
intellectual properties, patents and patent applications in the
field of human papillomavirus (HPV) vaccines. The licensing
agreement covers a United States patent application, two German
patent applications and two European patent applications. The
agreement complements MedImmune's current position in this field
which, in addition to its own internal HPV vaccine program, includes
licensing agreements and collaborations with Georgetown University,
University of Rochester and the Boyce Thompson Institute as well as
collaborations with University of California in Davis and
Pennsylvania State University. HPV causes genital warts and
cervical cancer.
"Human papillomavirus is both an important medical problem and an
important commercial opportunity for MedImmune," commented David M.
Mott, President and Chief Operating Officer of MedImmune. "Our
research and development group is making rapid progress towards
beginning human clinical trials later this year with our
preventative vaccine candidate for HPV, and our licensing group
continues its successful initiative to acquire important
intellectual property in this field. MedImmune is pleased to work
together with the prestigious German Cancer Research Center which
has been a pioneer in the efforts to discern the link between HPV
and cancer as well as other research linking viruses and cancer."
HPV is one of the most common sexually transmitted diseases in the
United States. HPV causes genital warts and cervical cancer and
creates an enormous medical burden worldwide in the diagnosis and
treatment of cancer or pre-cancerous lesions and the treatment of
genital warts. In the U.S. alone, HPV causes over 80,000 annual
cases of malignant cervical cancers, 15,800 of which are invasive
and result in over 4,800 fatalities each year. Studies have
indicated that the prevalence of HPV infection in the U.S. may be as
high as 40 percent in some populations, particularly in sexually
active women under age 30. In some areas where mass cancer
screening via Pap smears is inadequate, such as in Southeast Asia
and South and Central America, HPV-induced cervical cancer is the
leading cause of death by cancer in women. There are over 75 types
of HPV associated with various clinical disorders ranging from
benign to very dangerous. Four types cause the majority of genital
warts and cervical cancers: HPV-6, HPV-11, HPV-16 and HPV-18.
Currently, there are no vaccines to prevent HPV infection. To date,
research on HPV has been difficult because the virus cannot be grown
in vitro, and animal models designed to mimic HPV infection have
historically been imperfect. To address these difficulties,
MedImmune produces HPV virus-like particles (VLPs) in vitro using
recombinant DNA technology, enabling production of large quantities
of material which imitate the structure of natural papillomavirus,
but are not infectious. Additionally, MedImmune and its
collaborators have developed a model for HPV infection in dogs with
a virus called canine oral papillomavirus (COPV), which mimics HPV
infection more closely than other animal models because it produces
both warts and tumors at a mucosal site like HPV. In December 1995,
MedImmune and its collaborators published the results of studies
which indicated that a VLP vaccine preparation of COPV was able to
protect dogs completely against infection from COPV. These results,
MedImmune believes, suggest the feasibility of developing an
analogous vaccine against HPV for humans. MedImmune is currently in
pre-clinical development with a vaccine candidate made from the four
medically important HPV strains, the first of which the Company
plans to request approval by the FDA during 1996 to begin clinical
trials in humans.
"Cervical cancer is one of the most serious medical problems facing
women worldwide, and few outside of the medical field realize this
cancer is caused by a virus," added Harold zur Hausen, M.D., Ph.D.,
Scientific Director and Chairman of the Management Board of DKFZ.
"We believe MedImmune has the potential to be a leader in the
development of a vaccine to prevent diseases caused by this
important pathogen, and we look forward to a productive
collaboration."
DKFZ is the principal cancer research center in Germany. It is
funded by the German Federal Government and the State of Baden
Wurtemberg where it is located. The Center's $145 million annual
budget supports a staff of 1,500 including 700 scientists at its
Heidelberg Laboratories. DKFZ's scientists have a large network of
international collaborations. DKFZ has long had a reputation for
scientific excellence, marked by its status as a leading institution
in international scientific citation indexes. Under Dr. Zur
Hausen's leadership, DKFZ has long been a leader in tumor virology
research and has led investigations which have linked
papillomaviruses with a growing list of cancers and other skin
diseases.
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.
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
the Company's filings with the U.S. Securities and Exchange
Commission.
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 26, 1996 s/David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
