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: May 15, 1998
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, RespiGam and Synagis 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 May 14, 1998:
BIOTRANSPLANT AND MEDIMMUNE ANNOUNCE INITIAL CLINICAL SAFETY AND
PHARMACOKINETICS DATA FOR MEDI-507
Charlestown, MA and Gaithersburg, MD, May 14, 1998 -- BioTransplant
Incorporated (Nasdaq:BTRN) and MedImmune, Inc. (Nasdaq:MEDI) today announced
encouraging safety and pharmacokinetic results from a 13-patient, Phase I
clinical trial of MEDI-507, a humanized monoclonal antibody with potential
applications for treating transplant rejection and graft vs. host disease
(GvHD). The Phase I data, which indicated that MEDI-507 was generally well
tolerated, were presented today at the 24th Annual Scientific Meeting of the
American Society for Transplant Surgeons (ASTS) held in Chicago.
MEDI-507 is derived from BTI-322, a murine monoclonal antibody which has
demonstrated in clinical trials the potential to prevent and treat tissue
graft rejection in several transplant settings. BTI-322 was discovered by
Drs. Herve Bazin and Dominique Latinne at the Experimental Immunology Unit of
the Catholic University of Louvain, Belgium. MedImmune is developing MEDI-
507 under an exclusive license from BioTransplant.
"We are pleased that the safety results are consistent with our clinical
evaluation of BTI-322," commented Elliott Lebowitz, President and Chief
Executive Officer of BioTransplant. "In addition to its potential as a stand-
alone product developed by MedImmune, BioTransplant retains the rights to use
MEDI-507 in BioTransplant's proprietary ImmunoCognance trademark Systems
which are designed to re-educate the immune system to create tolerance to
transplanted tissue: AlloMune trademark for human-to-human transplants and
XenoMune trademark for porcine-to-human transplants."
The Phase I study presented at ASTS was an open-label, dose-escalating safety
trial in renal allograft recipients examining three dose levels (0.012, 0.06,
and 0.12 mg/kg/dose) of MEDI-507. Thirteen patients were given an initial
dose within six hours after kidney transplant surgery and a second dose 60-72
hours later. Results indicated that MEDI-507 was generally well tolerated
and no anti-MEDI-507 antibodies were detected following administration.
During the first 30 days of follow up, two patients experienced acute
rejection.
Based on encouraging results from Phase I/II clinical trials with BTI-322 for
the treatment of steroid resistant GvHD and acute transplant rejection,
MedImmune has initiated clinical evaluation of MEDI-507 to evaluate its
therapeutic properties. Both MEDI-507 and BTI-322 bind specifically to the
CD2 antigen receptor found on T cells and natural killer (NK) cells.
Previous in vitro studies have suggested that BTI-322 and MEDI-507 have the
ability to inhibit selectively the response of T cells directed at transplant
antigens while subsequently allowing immune cells to respond normally to
other antigens.
BioTransplant Incorporated is developing proprietary pharmaceuticals and
organ transplantation systems, which represent a comprehensive approach to
inducing long-term functional transplantation tolerance in humans.
BioTransplant's product candidates, which utilize BioTransplant's
ImmunoCognance trademark 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.
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 and any future
generation products, such as MEDI-507, for use in organ transplantation and
other indications. MedImmune is located in Gaithersburg, MD.
This press release includes forward-looking statements based on the current
expectations of the management of BioTransplant and MedImmune. Factors that
could cause future results to differ materially from such forward-looking
statements include, but are not limited to: the companies' ability to secure
future funding; the progress of the companies' research and development
programs and difficulties inherent in developing pharmaceuticals and
procedures for organ transplantation; uncertainties as to the extent of
future government regulation of the transplantation business; and the
companies' ability to maintain collaborations with third parties. For a
detailed discussion of these and other factors, see the companies' annual
reports on form 10-K for the year ended December 31, 1997, as well as other
documents filed with the Securities and Exchange Commission.
(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) May 15, 1998
