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: July 17, 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 and RespiGam are registered trademarks of the Company and Synagis is
a trademark.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated July 15, 1998:
BIOTRANSPLANT AND MEDIMMUNE REPORT PHASE II RESULTS OF BTI-322 TO TREAT GRAFT-
VERSUS-HOST DISEASE IN TRANSPLANT PATIENTS
-- Data Presented at the 17th Annual World Congress Meeting of the
Transplantation Society --
Montreal, Canada, July 15, 1998 -- BioTransplant Incorporated (Nasdaq: BTRN)
and MedImmune, Inc. (Nasdaq: MEDI) reported today data from a 20-patient,
Phase II clinical trial evaluating BTI-322 for treatment of acute, graft-
versus-host disease (GvHD) in bone marrow transplant patients unresponsive to
steroid therapy. In the trial, BTI-322, a murine monoclonal antibody, was
generally well-tolerated and 55 percent of the GvHD patients responded
positively to treatment, with either a complete response or a reduction in
grade of GvHD. These encouraging results were reported at the 17th Annual
World Congress Meeting of the Transplantation Society. The results were part
of the basis for the 15-center, Phase II trial currently underway evaluating
the humanized derivative of BTI-322, MEDI-507, for treatment of GvHD. GvHD
is a frequent and often fatal outcome of bone marrow transplantation and is
currently treated with steroids. The mortality rate for serious steroid-
refractory GvHD cases is estimated to be over 70 percent.
"All of the participants in this trial were experiencing severe GvHD and were
unable to respond to the best therapies currently available," commented Bruce
McClain, M.D., Director, Clinical Development at MedImmune. "The fact that
we saw substantial clinical improvement after treatment with BTI-322 in 11
patients, six of whom had complete resolution, made us very hopeful that BTI-
322 may have a positive biological effect against GvHD, which is both
difficult to treat and often fatal."
"Some of the patients responding to BTI-322 later experienced a relapse after
treatment was completed, indicating that further studies of treatment regimens
may be necessary," added Dr. McClain. "For that reason, we have extended the
dosing of its sister molecule, MEDI-507, in an ongoing clinical trial to
evaluate whether the BTI-322 results in treating GvHD can be improved with
MEDI-507."
BioTransplant exclusively licensed BTI-322 and MEDI-507 to MedImmune for
evaluation and potential commercialization as anti-rejection pharmaceuticals
for organ and tissue transplantation, in addition to the potential use of MEDI-
507 to treat autoimmune diseases. MedImmune is responsible for all activities
related to commercialization, and BioTransplant would receive milestone
payments at various stages related to regulatory approval and royalties if the
products are commercialized. BioTransplant has retained the right to use BTI-
322 and/or MEDI-507 in its proprietary ImmunoCognance trademark systems, which
are designed to reeducate the immune system to accept foreign tissue:
AlloMune trademark for human-to-human transplants and XenoMune trademark for
porcine-to-human transplants.
GvHD is a clinical syndrome caused when certain white blood cells from the
donor bone marrow attack the tissue of the recipient. Clinical manifestations
include skin rash, severe diarrhea, and liver abnormalities and jaundice.
Liver involvement is usually the most serious. GvHD is usually treated with a
first-line therapy of corticosteroids. Steroid-refractory GvHD occurs when the
attacking white blood cells of the foreign graft fail to respond to steroid
therapy.
The Phase II study was conducted at six transplantation centers in 20 patients
who received allogeneic (non-self donated) bone marrow or stem cell
transplantation, and who experienced acute GvHD that was unresponsive to
steroid treatment. The primary endpoints in the study were safety and
reduction in grade of GvHD. All 20 patients received a single daily dose of
BTI-322 (0.1 mg/kg) for ten consecutive days, in conjunction with a standard
immunosuppression treatment regimen. The grade of GvHD was measured on a
scale of 1 (mild) to 4 (severe) with patients experiencing an overall
reduction in the grade of GvHD from 2.95 to 1.80 (p=0.0005). For the trial,
11 patients responded positively to treatment, with six patients experiencing
a complete response to treatment and five patients showing a reduction in the
grade of GvHD. In three patients the grade of GvHD did not progress to a more
severe stage. The grade of GvHD decreased from 2.82 to 0.73 (p<0.00001) for
the 14 patients who responded to the BTI-322 therapy. Aside from
mild/moderate first dose reactions, patients tolerated the BTI-322 well.
Results of the study were presented by Donna Przepiorka, M.D., Ph.D., of the
M.D. Anderson Cancer Center in Houston, the lead investigator of the study.
BTI-322 has been evaluated to date in pilot clinical trials of over 100
patients in the U.S. and Europe. A Phase I/II controlled trial was completed
for the prevention of kidney transplant rejection in which BTI-322 was given
at the time of organ transplantation. Results of the trial demonstrated a 58
percent reduction after one year in the incidence of kidney graft rejection
episodes compared to conventional triple drug therapy alone, as well as a
reduction in delayed graft function. Initial clinical studies with MEDI-507
in a Phase I trial in renal transplant recipients indicated that MEDI-507 was
well tolerated. MedImmune has also commenced a Phase I clinical trial
evaluating MEDI-507 to treat the autoimmune disorder psoriasis.
BTI-322 was discovered by Drs. Herve Bazin and Dominique Latinne at the
Experimental Immunology Unit of the Catholic University of Louvain, Belgium,
licensed to BioTransplant and subsequently licensed to MedImmune. 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 suggest 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 three
products through its hospital-based sales force and has four 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) July 17, 1998
