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: April 15, 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 April 15, 1997.
MEDIMMUNE AND BIOTRANSPLANT SUBMIT IND TO BEGIN
FIRST HUMAN CLINICAL TRIAL WITH MEDI-507
Gaithersburg, MD, and Charlestown, MA, April 15, 1997 -- MedImmune,
Inc. (Nasdaq:MEDI) and BioTransplant Incorporated (Nasdaq:BTRN) today
announced they have submitted an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration (FDA) to begin the
first human clinical trial with MEDI-507, a humanized monoclonal
antibody, which the Companies believe may have several potential
applications in transplantation medicine and autoimmune diseases. BTI-
322, which has been evaluated in several transplantation settings to
date, is the rat form of MEDI-507. Elliot Lebowitz, Ph.D., President
and Chief Executive Officer of BioTransplant, made today's announcement
at the Union Bank of Switzerland (UBS) Life Sciences Conference in
London.
"BTI-322 has provided encouraging results in Phase 1/2 clinical trials
in the treatment and prevention of acute renal transplant rejection,"
commented Dr. Lebowitz. "Both BioTransplant and MedImmune believe that
the humanized form of BTI-322, MEDI-507, will retain its properties for
those indications, with expanded potential for chronic administration
as a treatment for autoimmune disorders such as psoriasis, inflammatory
bowel disease and rheumatoid arthritis."
Both MEDI-507 and BTI-322 bind specifically to the CD2 antigen receptor
found on T cells and natural killer (NK) cells. Laboratory studies have
suggested that BTI-322 and MEDI-507 primarily inhibit the response of T
cells directed at transplant antigens while subsequently allowing
immune cells to respond normally to other antigens. The selectivity
and long lasting effects of this inhibition suggest that these
molecules may have potential utility in applications other than
transplantation, such as in autoimmune diseases. The initial study
proposed is a Phase 1 open-label, dose-escalating, renal
transplantation induction trial to evaluate MEDI-507 for the first time
in humans in the same clinical setting where BTI-322 has demonstrated
potential clinical benefit and has been generally well tolerated.
BTI-322 has been evaluated in over 60 patients in the United States and
Europe for its potential to prevent and treat organ graft rejection and
graft-versus-host disease (GvHD). Currently, BTI-322 is being
evaluated in a multi-center Phase 2 trial for treatment of acute GvHD.
In addition, preliminary analyses of data from two Phase 1/2 clinical
studies were presented in August 1996 at the XVI International Congress
of the Transplantation Society in Barcelona, Spain. BTI-322 in these
studies appeared well-tolerated and showed initial promise in
preventing and treating kidney transplant rejection. A Phase 1/2
clinical trial evaluating BTI-322 in the treatment of acute kidney
rejection is underway at the Massachusetts General Hospital under an
IND application submitted to the FDA by BioTransplant. 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 six
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 specific transplantation
tolerance in humans. The Company's product candidates are intended to
reduce or eliminate the need for lifelong immunosuppressive therapy,
reduce the cost of treating end-stage organ disease and increase the
supply of transplantable organs. BioTransplant is located in
Charlestown, MA.
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 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.
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.
MEDIMMUNE, INC.
Registrant)
Date: April 15, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
