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: November 26, 1997
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.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated November 25, 1997:
MEDIMMUNE AND BIOTRANSPLANT ANNOUNCE PLANS
TO TEST NEW DRUG FOR PSORIASIS
- MedImmune Submits IND to Begin First Clinical Trial With MEDI-507 for
Autoimmune Disease -
Gaithersburg, MD, and Charlestown, MA, November 25, 1997 -- MedImmune, Inc.
(Nasdaq:MEDI) and BioTransplant, Incorporated (Nasdaq:BTRN) today announced
MedImmune has submitted an Investigational New Drug (IND) application to the
U.S. Food and Drug Administration (FDA) requesting clearance to begin a Phase
1 clinical trial evaluating the safety of escalating doses of MEDI-507 in
patients with psoriasis. Psoriasis, a common skin condition which causes
considerable discomfort and emotional distress, is believed to be a T cell
mediated autoimmune disease. The Companies believe that MEDI-507's unique
ability to modulate specific T cells may make it an ideal candidate for
treating certain autoimmune disorders, including psoriasis. MEDI-507 and its
predecessor, BTI-322, have been evaluated in humans for several indications
including prevention and treatment of organ transplant rejection and
treatment of graft-versus-host disease (GvHD).
"We are currently exploring several applications for MEDI-507," commented
David M. Mott, President and Chief Operating Officer of MedImmune. "The study
proposed today will provide us with an initial indication of MEDI-507's
potential for treating psoriasis and other autoimmune diseases, which if
successful, could greatly expand the market for the product, beyond
transplantation."
Psoriasis is a common chronic, recurrent disease characterized by dry,
scaling, red lesions on the skin. Approximately 6 million Americans have
psoriasis, with between 150,000 and 260,000 new cases reported each year.
Approximately 10 percent of people who have psoriasis may also develop a mild
arthritis in the hands and feet which can become disabling. There is no cure
for psoriasis and the treatments are often inconvenient, difficult to use or
cause side effects. Annual outpatient costs for psoriasis management range
from approximately $1 billion to $3 billion.
"Psoriasis is a large medical problem," commented Franklin H. Top, Jr., M.D.,
Executive Vice President and Medical Director of MedImmune. "We are hopeful
that in psoriasis patients, MEDI-507 may be effective in regulating the T
cells which appear to be important in the mechanism of the disease."
The study proposed is a Phase 1 open-label, dose-escalating trial to evaluate
the safety and disease response of MEDI-507 when administered to patients
with psoriasis. The study will be conducted at 3 clinical centers and will
begin following FDA clearance of the IND. The Company expects to evaluate
MEDI-507 in other autoimmune settings based on the results of the current
study.
MEDI-507 is a humanized monoclonal antibody which binds specifically to the
CD2 surface antigen receptor found on T cells and natural killer (NK) cells.
MEDI-507 was engineered from BTI-322, a murine antibody, in order to reduce
potential immunogenicity and allow for long term administration. Laboratory
studies have suggested that MEDI-507 and BTI-322 primarily inhibit the
response of specific activated T cells while subsequently allowing other
immune cells to respond normally. BTI-322, previously known as LO-CD2a, was
discovered by Drs. Herve Bazin and Dominique Latinne at the Catholic
University of Louvain in Belgium.
A Phase 1 kidney transplant study with MEDI-507 is in progress and initial
results suggest MEDI-507 is generally well tolerated. In addition, BTI-322
has been evaluated in several Phase 1 and Phase 1/2 clinical trials in the
United States and Europe involving approximately 100 patients to prevent and
treat organ graft rejection and for treatment of GvHD.
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 five new product
candidates in clinical trials. In October 1995, MedImmune and BioTransplant
established a strategic alliance for development of BTI-322, MEDI-500 (T10B9)
and any future generations of these products (such as MEDI-507) for use in
organ transplantation and other indications. MedImmune is located in
Gaithersburg, MD.
BioTransplant, Incorporated is developing proprietary anti-rejection
pharmaceuticals and organ transplantation systems, which represent a
comprehensive approach to inducing long-term functional transplantation
tolerance in humans. The Company's product candidates, which utilize
BioTransplant's ImmunoCognance technology, are intended to reduce or
eliminate the need for lifelong immunosuppressive therapy, increase the
supply of transplantable organs and reduce the cost of treating end-stage
organ disease.
This announcement may contain, in addition to historical information, certain
forward-looking statements, including statements about the potential
therapeutic benefits of BTI-322 and MEDI-507, that involve risks and
uncertainties. Such statements reflect current views of the management of
both Companies 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. Commercialization
of MEDI-507 and BTI-322 will require prior approval from regulatory
authorities, including the Food and Drug Administration in the U.S. There
can be no assurance that such approvals will be obtained.
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.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, President and Chief Operating Officer
(Principal financial and accounting officer)
(DATE) November 26, 1997
