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 11, 1996
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
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MEDIMMUNE FILES IND TO BEGIN HUMAN CLINICAL TRIALS FOR FIRST
PREVENTATIVE HUMAN PAPILLOMAVIRUS VACCINE CANDIDATE
Gaithersburg, MD, December 11, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced it has submitted an Investigational New Drug (IND)
application to the United States Food and Drug Administration (FDA) to
initiate human clinical trials with a vaccine for the prevention of
human papillomavirus (HPV) disease of the genital tract. The clinical
trial, to be conducted at the University of Rochester Medical Center,
will assess the safety and immunogenicity of MedImmune's first HPV
vaccine candidate. HPVs are responsible for the development of genital
warts and cervical cancer. There are currently no vaccines to prevent
these common sexually transmitted diseases that affect 24 to 40 million
men and women in the United States.
"An HPV vaccine represents a strategic priority for MedImmune because
of the significant unmet medical need, the strong scientific basis for
our vaccine candidate and the large market potential," commented David
M. Mott, President and Chief Operating Officer of MedImmune. "The
filing of an IND for our HPV vaccine candidate is an important
milestone and achievement for our researchers at MedImmune and for our
collaborators at Georgetown University, the University of Rochester and
The German Cancer Institute in Heidelberg."
HPV is one of the most common sexually transmitted diseases in the
United States. There are over 75 types of HPV which induce either
benign lesions or potentially lethal cancers. Four types cause the
large majority of genital warts and cervical cancer cases: HPV-6, HPV-
11, HPV-16, and HPV-18.
Clinical management of genital warts and cervical cancer is a major
medical burden worldwide. Since the 1960s there has been a 6-fold
increase in the number of physician visits each year for the treatment
of genital warts. Follow-up physician visits and repeated treatments
are typically required in order to reduce symptoms. One study suggests
that in the United States, approximately 35-50% of genital wart cases
recur after initial treatment.
Cervical cancer develops in stages and often requires multiple
diagnostic procedures to determine the extent of the disease. If the
cancer is detected early through screening methods such as Pap smears,
medical intervention is often curative. However, in some areas where
screening is inadequate, HPV-induced cervical cancer is the leading
cause of death by cancer in women. Treatments for invasive cancer
include chemotherapy, radiation therapy, and surgery. In the U.S.
alone, there are over 80,000 annual cases of cervical cancers, 15,800
of which are invasive and result in over 4,800 deaths each year.
"The consequences of HPV infection are potentially life-threatening to
women and create an urgent need for a vaccine to prevent the diseases
caused by this virus," commented JoAnn Suzich, Ph.D., Director,
Laboratory of Biological Chemistry at MedImmune and leader of
MedImmune's HPV vaccine project.
MedImmune is developing vaccines for several HPV types associated with
genital warts and cervical cancer. MedImmune's first vaccine
candidate, MEDI-501, is composed of the HPV-11 L1 capsid protein which
self assembles into virus-like particles (VLPs). The VLPs, which are
produced in vitro using recombinant DNA technology, imitate the
structure of natural papillomavirus, but are not infectious.
Scientists at MedImmune in colloboration with a team at Georgetown
University, led by Drs. Richard Schlegel and A. Bennett Jenson, have
demonstrated the effectiveness of a VLP vaccine candidate using a dog
model for papillomavirus infection. The model involves a virus called
canine oral papillomavirus (COPV) which mimics HPV infection closely
because it produces both warts and tumors at a mucosal site. In
December 1995, MedImmune and its collaborators published the results of
studies which indicated that a COPV VLP vaccine preparation was able to
protect dogs completely against COPV warts. That study provided the
scientific rationale for developing an analogous vaccine for humans.
"We've been working for many years toward the goal of evaluating a
promising HPV vaccine in people, and now we have reached that important
milestone," commented Richard Reichman, M.D., Head of the Infectious
Disease Unit at the University of Rochester Medical Center and the
Principal Investigator of the vaccine trial.
MedImmune plans to evaluate the safety, tolerance, and immunogenicity
of MEDI-501 in a placebo-controlled dose-escalating trial involving
healthy adult volunteers. The trial is expected to be concluded
approximately 12 months from its commencement.
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. The company currently
markets two products and has six new product candidates in clinical
trials; an HPV vaccine would be the seventh. MedImmune is located in
Gaithersburg, Maryland.
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. There can be
no assurances that the FDA will review and accept MedImmune's IND
application in a timely manner.
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: December 11, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
