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: December 16, 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 December 14, 1998:
MEDIMMUNE AND BIOTRANSPLANT ANNOUNCE INITIATION OF TWO NEW CLINICAL STUDIES AND
ORPHAN DRUG DESIGNATION OF MEDI-507
Gaithersburg, MD, and Charlestown, MA, December 14, 1998 -- MedImmune, Inc.
(Nasdaq: MEDI) and BioTransplant Incorporated (Nasdaq: BTRN) today announced
their plans to initiate two new Phase 1/2 clinical trials to evaluate MEDI-507
as treatment for acute graft-versus-host disease (GvHD) in steroid-naive adults
and pediatric patients. Additionally, MedImmune announced MEDI-507 has received
orphan drug designation from the United States Food and Drug Administration
(FDA), providing the Company seven years of market exclusivity if MedImmune is
the first to receive marketing approval for the orphan drug in the designated
indication. MEDI-507 specifically targets immune cells believed responsible for
organ rejection and GvHD. The companies believe MEDI-507 may have several
potential applications in transplantation medicine and autoimmune diseases.
In the first study which is placebo-controlled, adult steroid-naive bone marrow
transplant (BMT) or stem cell transplant (SCT) recipients will receive MEDI-507
combined with corticosteroids (methylprednisolone) for initial treatment of
acute GvHD. Because this study would be the first to evaluate MEDI-507 as part
of initial treatment of GvHD, all patients are expected to receive the standard
initial GvHD treatment with corticosteroids. It is anticipated that this Phase
1/2 trial will include up to 32 patients recruited from up to 15 centers. The
trial protocol has been approved by the FDA, and patient recruitment has begun.
In the second study, MEDI-507 will be assessed in an open-label trial for its
ability to treat GvHD in pediatric BMT or SCT patients. There is a high
morbidity and mortality rate associated with acute GvHD, and currently there are
no agents approved for the treatment of this disease in children. Up to 20
pediatric patients (age 2-17) are expected to be recruited from at least ten
centers for this Phase 1/2 study. The clinical trial protocol has been
submitted for approval to the FDA and if approved, the study will commence
enrollment following the entry of initial patients in the adult trial.
Additionally, the companies also announced the conclusion of the initial Phase
1/2 study evaluating MEDI-507 for the treatment of GvHD in adult steroid-
resistant SCT or BMT patients. The data from this trial are currently being
analyzed. The results of this trial are expected to be presented at a medical
conference in 1999.
MedImmune has received orphan drug designation from the Office of Orphan
Products Development of the FDA for MEDI-507 for the treatment of GvHD. The
Orphan Drug Act was established to encourage development of drugs for rare
diseases and conditions affecting a small patient population (generally less
than 200,000 people). Orphan designation of a product can potentially provide a
company with seven years of market exclusivity if the company is the first to
receive FDA product marketing approval for the orphan drug in the designated
indication. Additionally, this designation provides a company with tax credits
of 50 percent for clinical research expenses and the opportunity for clinical
research grants.
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 population and has
been generally well-tolerated. In a Phase 1/2 clinical trial evaluating BTI-322
for treatment of acute GvHD in 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.
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 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, located in Charlestown, Massachusetts, 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 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 reeducate
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, located in Gaithersburg, Maryland, 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.
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.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, Vice Chairman and Chief Financial Officer
(DATE) December 16, 1998
