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 19, 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.
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 19, 1999:
FOR IMMEDIATE RELEASE
Contacts:
Mark E. Kaufmann Elliot Lebowitz, Ph.D.
Director, Planning and Analysis President and Chief Executive
MedImmune, Inc. Officer
301-417-0770 x321 BioTransplant Incorporated
617-241-5200
William C. Roberts
Investor and Media Relations Fran DeVellis or
MedImmune, Inc. Bruce Schiamberg
301-417-0770 x358 Feinstein Kean Partners
617-577-8110
http://www.medimmune.com
http://www.biotransplant.
com
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MEDIMMUNE AND BIOTRANSPLANT ANNOUNCE CLINICAL RESULTS AT
AMERICAN SOCIETY OF TRANSPLANTATION MEETING
- - Companies Announce Results of BTI-322 Study; MedImmune Announces Results of
CytoGam Study -
Gaithersburg, MD, and Charlestown, MA, May 19, 1999 -- MedImmune, Inc. (Nasdaq:
MEDI) and BioTransplant Incorporated (Nasdaq: BTRN) today announced preliminary
results of a Phase 1/2 clinical trial in which BTI-322 monoclonal antibody,
given in combination with Prograf(Trademark) (tacrolimus, a calcineurin
inhibitor; Fujisawa) after liver transplantation, significantly lowered the
incidence of histological organ rejection compared to Prograf(Trademark) alone.
The data from the study were presented at the American Society of
Transplantation (AST) 18th Annual Scientific Meeting in Chicago. MedImmune also
reported the results of another study, also presented at AST, which showed that
CytoGam (Cytomegalovirus Immune Globulin Intravenous (Human); CMV-IGIV), given
after renal transplantation in patients at high risk of cytomegalovirus (CMV)
infection, significantly lowered the incidence of several markers of CMV
infection and organ rejection compared to standard intravenous immune globulin
(IGIV).
The first study, by Jan P. Lerut, M.D., et al., "The Use Of Tacrolimus (TAC) And
Anti-CD2 Antibody Lo-CD2a (BTI-322) In Adult Liver Transplantation (LT):
Preliminary Results Of A Prospective Randomized Study," included 31 liver
transplant recipients who received combination immunosuppression using
Prograf(Trademark) and low dose steroids with or without a 10 day IV course of
BTI-322. The results indicated that the combined use of BTI-322 with Prograf
(Trademark) lowered the incidence of histological rejection in the immediate
post-operative period by 70% compared to Prograf(Trademark) alone (24 percent
vs. 79 percent; p=0.009) without increasing the rates of bacterial or viral
infection.
"A monoclonal antibody with the properties of BTI-322 after liver transplant
could allow for easier post-operative care and management of these very ill
patients who are vulnerable to toxicity associated with calcineurin inhibitors,"
commented Dr. Lerut, Professor of Surgery at Cliniques Saint Luc, University of
Louvain, Brussels.
"These data provide for an important product opportunity; the available data
suggest the ability to specifically inhibit the T cell response against
transplant antigens and subsequently prevent organ rejection," added Elliot
Lebowitz, Ph.D., President and Chief Executive Officer of BioTransplant. "Both
BioTransplant and MedImmune anticipate that the same activity will be
demonstrated by MEDI-507, BTI-322's humanized sister molecule, now being
evaluated in clinical trials for treatment of acute graft-versus-host disease
and autoimmune disease. Additionally, both BTI-322 and MEDI-507 may play a key
role in BioTransplant's ImmunoCognance(Trademark) systems, including
AlloMune(Trademark) for human-to-human transplants and XenoMune(Trademark) for
porcine-to-human transplants."
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The second study, "Efficacy Of CMV-IGIV Versus Standard IGIV In Reducing Post-
Transplant CMV Infection," by Hamid Shidban, M.D., et al., reviewed hospital
records of renal transplant patients at high risk of primary CMV infection (CMV
seronegative patients who received CMV seropositive organs) to compare
CytoGam(n=48) to standard IGIV (n=46) in reduction of markers associated with
organ rejection and post-transplant CMV infection. Compared to the standard IGIV
group, the group that received CytoGam had a significantly lower incidence of
CMV infection (p=0.004), rejection rate at one year (p=0.04), graft loss
(p=0.0002) and mortality at one year (p=0.03). Dr. Shidban is the Assistant
Professor of Urology and Medicine at the University of Southern California
School of Medicine.
"We are pleased to see that CytoGam reduces the risks faced by renal transplant
patients," said Robert Hirsch, Ph.D., Vice President of Medical Affairs at
MedImmune. "The results confirm CytoGam's ability to prevent CMV infection.
CytoGam is indicated for prophylaxis against CMV disease associated with
transplantation of kidney, lung, liver, pancreas, and heart." Please see full
prescribing information for CytoGam attached or at
www.medimmune.com/products/cytopil.htm
BTI-322/MEDI-507
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. A trial evaluating MEDI-507 for treatment of GvHD in
steroid-resistant BMT patients has been completed and results are expected to be
presented at the International Society for Hematology in Monaco in July. Two
additional Phase 1/2 clinical trials have been developed to evaluate MEDI-507 as
treatment for acute GvHD in steroid-nave adult and pediatric patients.
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. Herv Bazin
and Dominique Latinne at the Experimental Immunology Unit of the Catholic
University of Louvain in Belgium.
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CytoGam
CytoGam is indicated for prophylaxis against cytomegalovirus (CMV) disease
associated with transplantation of kidney, lung, liver, pancreas, and heart. In
transplants of these organs, other than kidney from CMV seropositive donors into
CMV seronegative recipients, CytoGam should be considered in combination with
gancyclovir. CytoGam is an intravenous immune globulin enriched in antibodies
against CMV. CytoGam is made from human plasma and, like other plasma products,
carries the possibility for transmission of blood- borne viral agents. The risk
of transmission of recognized blood-borne viruses is considered to be low
because of the viral inactivation and removal procedures employed in the
manufacture of CytoGam. Minor reactions such as flushing, chills, muscle cramps,
back pain, fever, nausea, vomiting, arthralgia, and wheezing were the most
frequent adverse reactions observed during the clinical trials of CytoGam.
CytoGam is marketed by MedImmune and manufactured by Massachusetts Biologic
Laboratories.
BioTransplant Incorporated utilizes its proprietary technologies in reeducating
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) May 19, 1999
