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 13, 1999
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 office (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.
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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 12, 1999:
FOR IMMEDIATE RELEASE
Contacts: Elliot Lebowitz, Ph.D.
William C. Roberts President and Chief Executive Officer
Investor and Media Relations BioTransplant Incorporated
MedImmune, Inc. 617-241-5200
301-417-0770 x358
Fran DeVellis or
Bruce Schiamberg
Feinstein Kean Partners
617-577-8110
http://www.medimune.com
http://www.biotransplant.com
MEDIMMUNE AND BIOTRANSPLANT ANNOUNCE RESULTS OF MEDI-507 TRIAL IN SEVERE
STEROID-RESISTANT GRAFT-VERSUS-HOST DISEASE PATIENTS
Gaithersburg, MD, and Charlestown, MA, July 12, 1999 -- MedImmune, Inc. (Nasdaq:
MEDI) and BioTransplant Incorporated (Nasdaq: BTRN) today announced the
presentation of data from a Phase 1/2 trial with MEDI-507 in patients with
steroid-resistant, severe graft-versus-host disease (GvHD). In the trial, 12 of
17 participants had improvement in their GvHD grade during the follow-up period
after treatment with MEDI-507; 10 patients achieved a complete response (grade
0) at some point during the study. These results were presented this week at the
28th Annual Meeting of the International Society for Experimental Hematology.
GvHD is a frequent and often fatal outcome of bone marrow transplantation and is
currently treated with corticosteroids. The mortality rate for serious
steroid-resistant GvHD cases is estimated to be over 70 percent.
"We are encouraged by the responses seen in these severe GvHD patients who were
all unresponsive to standard steroid therapy," commented Edward Connor, M.D.,
Vice President of Clinical Development at MedImmune. "GvHD is a very difficult
disease to treat; the data from this initial trial suggest biological activity
for MEDI-507 in GvHD."
Using the consensus classification based on biopsies, seven patients with GvHD
grade II and 10 patients with GvHD grade III-IV were enrolled in this study. All
but four of the patients had gut and/or liver involvement. Patients received a
short regimen of four doses of 0.12 mg/kg intravenous MEDI-507 given every third
day and then either placebo or additional doses of 0.12 mg/kg intravenous
MEDI-507 weekly for four weeks. Patients were followed for 100 days. Of the 17
patients in the trial, 12 improved their grade of GvHD and 10 achieved grade 0
at some point during follow-up. Treatment with MEDI-507 was generally well
tolerated, and no antibodies to MEDI-507 were detected. Eleven patients
experienced acute adverse events associated with MEDI-507, including chills,
fever and nausea. These events were generally mild and did not interrupt
therapy. Notwithstanding improvements in GvHD in certain patients, 12 of the 17
patients ultimately died during the 100 day period, typically as a result of
progression of their GvHD or complications such as infections. These data were
presented by the lead investigator of the study, Voravit Ratanatharathorn, M.D.,
of the University of Michigan Hospital.
Dr. Connor added, "We have now gone on to begin a randomized, controlled dose
ranging study in steroid naive GvHD patients. We hope to optimize the dose
regimen to further improve and extend the clinical benefit. In addition to the
work we are doing in GvHD, we are also evaluating MEDI-507 in a Phase 1 trial in
psoriasis patients."
"MEDI-507's ability to selectively block immune responses and to prevent the
rejection of transplanted cells or tissue is also an important part of
BioTransplant's ImmunoCognance(trademark) approach," said Elliot Lebowitz,
Ph.D., President and CEO of BioTransplant.
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.
Steroid-refractory GvHD occurs when the attacking white blood cells of the
foreign graft fail to respond to steroid therapy.
MEDI-507 is the humanized form of the murine monoclonal antibody, BTI-322. In
pilot clinical trials in over 100 patients in the United States and Europe,
BTI-322 has suggested potential clinical benefit in the studied populations and
has been generally well tolerated. In a Phase 1/2 clinical trial evaluating
BTI-322 for treatment of acute graft-versus-host disease (GvHD) in bone marrow
transplant (BMT) patients unresponsive to steroid therapy, the compound was well
tolerated and 55 percent of the patients responded positively to treatment, with
either a complete response or a reduction in grade of GvHD. A Phase 1/2 trial
has been completed for the prevention of acute renal transplant rejection in
which BTI-322 was given at the time of organ transplantation. Results of the
trial suggested a 58 percent reduction at two years post-transplant in the
incidence of kidney graft rejection episodes compared to conventional triple
drug therapy alone. Two additional Phase 1/2 clinical trials have been developed
to evaluate MEDI-507 as treatment for acute GvHD in steroid-naive adults and in
pediatric patients. MedImmune has also initiated Phase 1 studies in psoriasis,
an autoimmune disease.
Both MEDI-507 and BTI-322 bind specifically to the CD2 receptor found on T cells
and natural killer (NK) cells. Previous in vitro studies have suggested that
MEDI-507 has 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. BTI-322 was initially discovered by Drs. Herve Bazin
and Dominique Latinne at the Experimental Immunology Unit of the Catholic
University of Louvain in Belgium.
BioTransplant Incorporated utilizes its proprietary technologies in re-educating
the body's immune responses to allow tolerance of foreign cells, tissues and
organs. Based on this technology, the Company is developing a portfolio of
products designed to treat a range of medical conditions, including organ and
tissue transplantation, cancer and autoimmune disease, for which current
therapies are inadequate. BioTransplant's products are intended to induce
long-term functional transplantation tolerance in humans, increase the
therapeutic benefit of bone marrow transplants, and reduce or eliminate the need
for lifelong immunosuppressive therapy. MedImmune is developing MEDI-507 under
license from BioTransplant, and BioTransplant has retained the right to use
BTI-322 and/or MEDI-507 in its proprietary ImmunoCognance(trademark) systems,
which are designed to re-educate the immune system to accept foreign tissue: the
AlloMune(trademark) System for human-to-human transplantation, and the
XenoMune(trademark) System for porcine-to-human transplantation.
MedImmune, a biotechnology company located in Gaithersburg, Maryland, is focused
on developing and marketing products that address medical needs in areas such as
infectious disease, transplantation medicine, autoimmune disorders and cancer.
The Company currently markets Synagis (palivizumab), RespiGam (Respiratory
Syncytial Virus Immune Globulin Intravenous (Human)), and CytoGam
(Cytomegalovirus Immune Globulin Intravenous (Human)) 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.
This announcement may contain, in addition to historical information, certain
forward-looking statements 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 both
companies' filings with the U.S. Securities and Exchange Commission.
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(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) July 13, 1999
