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 29, 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 December 24, 1997:
MEDIMMUNE AND BIOTRANSPLANT ANNOUNCE PLANS TO TEST MEDI-507 FOR TREATMENT OF
GRAFT-VERSUS-HOST DISEASE; IND SUBMITTED
Gaithersburg, MD, and Charlestown, MA, December 24, 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
1/2 clinical trial evaluating the safety of MEDI-507, a humanized monoclonal
antibody, in patients with steroid resistant graft-versus-host disease
(GvHD). GvHD is a potentially life-threatening complication of bone marrow
and stem cell transplantation. MEDI-507's predecessor, BTI-322, has been
evaluated in humans for several indications including prevention and
treatment of organ transplant rejection and treatment of GvHD.
"With the increase in bone marrow and stem cell transplants, GvHD, a common
and potentially fatal disease, is of great concern to transplant physicians,"
commented Edward M. Connor, M.D., Vice President, Clinical Affairs at
MedImmune. "MEDI-507 targets the specific cells which are believed to
mediate GvHD and we are hopeful it will provide an effective treatment for
the significant number of patients who are not responsive to existing
therapies."
GvHD is the most common complication of bone marrow or stem cell
transplantation. The number of allogeneic bone marrow and stem cell
transplants has increased significantly over the last few years to over
10,000. Approximately 50 percent of bone marrow transplants result in GvHD
which occurs when immune cells of the foreign graft, i.e., the donor bone
marrow, initiate an inflammatory reaction against the tissues of the
recipient. Typically, the disease is treated with steroids although
approximately 50 percent of patients fail to respond to steroid therapy.
Patients who develop moderate or severe GvHD have over a 70 percent chance of
death despite diverse treatments. Lack of understanding of the physiologic
mechanism of disease has been a major impediment to the development of more
effective treatments. Both T cells and natural killer (NK) cells may play a
role in the pathophysiology of GvHD. MEDI-507 which specifically inhibits
both types of cells may provide certain advantages over current therapies.
The study proposed is a Phase 1/2 trial to evaluate the safety,
pharmacokinetics and immunogenicity of two dosing regimens of MEDI-507 when
administered to patients with acute GvHD unresponsive to steroid treatment.
The study will be conducted at approximately 10 clinical centers if the FDA
concurs after review of the IND. A Phase 1 kidney transplant study with MEDI-
507 is in progress and preliminary results suggest MEDI-507 is generally well-
tolerated. In addition, MedImmune recently submitted an IND to begin clinical
testing of MEDI-507 in psoriasis patients. BTI-322 has been evaluated in
several Phase 1/2 and Phase 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.
MEDI-507 is a humanized monoclonal antibody which binds specifically to the
CD2 surface antigen receptor found on T cells and NK cells. MEDI-507 was
engineered from BTI-322, a rat 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.
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.
(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) December 29, 1997
