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: April 1, 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.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated March 31, 1998:
BIOTRANSPLANT AND MEDIMMUNE ANNOUNCE ISSUANCE OF U.S. PATENT
COVERING MEDI-507 AND BTI-322 ANTIBODIES
Charlestown, MA and Gaithersburg, MD, March 31, 1998 -- BioTransplant
Incorporated (Nasdaq: BTRN) and MedImmune, Inc. (Nasdaq: MEDI) today
announced that the U.S. Patent and Trademark Office has issued patent no.
5,730,979 for the companies' antibodies BTI-322 and MEDI-507, the humanized
form of BTI-322. The patent, licensed exclusively to BioTransplant and
sublicensed to MedImmune, covers composition of matter and the use of BTI-322
and MEDI-507 to inhibit T cell-mediated immune response. Both BTI-322 and
MEDI-507 selectively target specific immune cells believed responsible for
organ rejection, graft versus host disease (GvHD) and certain autoimmune
diseases.
"We are gratified with the recognition that this patent provides for the
novel and important work done by our collaborators at BioTransplant and at
the University of Louvain," commented David M. Mott, President and Chief
Operating Officer of MedImmune. "Together, we continue to make important
progress both in the clinic and in the laboratory toward fully understanding
the potential of these molecules to enhance patient care and advance the
field of transplantation."
Elliot Lebowitz, Ph.D., President and Chief Executive Officer of
BioTransplant added: "The patent advances MedImmune and BioTransplant's
proprietary position as we seek to develop BTI-322 and MEDI-507 as stand-
alone products. In addition, these compounds could play a substantial role
in BioTransplant's ImmunoCognance systems: AlloMune for human-to-human
transplants and XenoMune for porcine-to-human transplants.
BioTransplant exclusively licensed MEDI-507 and BTI-322 to MedImmune for
evaluation and potential commercialization as a therapy for indications such
as organ transplant rejection, GvHD and autoimmune diseases. MedImmune is
responsible for all activities related to commercialization, and
BioTransplant will receive royalties on sales, if any. BioTransplant has
retained the right to use BTI-322 and/or MEDI-507 in its AlloMune and
XenoMune systems. BTI-322 was discovered by Drs. Herve Bazin and Dominique
Latinne at the Experimental Immunology Unit of the Catholic University of
Louvain, Belgium.
In pilot clinical trials in over 100 patients in the U.S. and Europe, BTI-322
has demonstrated potential clinical benefit and has been generally well
tolerated. A Phase I/II trial has been 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 for the prevention of
transplant rejection are underway. Encouraging results for treatment of
steroid resistant GvHD were demonstrated in a Phase I/II trial with BTI-322
and an Investigational New Drug (IND) application for MEDI-507 was submitted
for this indication. MedImmune has also submitted an IND for MEDI-507 to
treat the autoimmune disorder psoriasis.
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 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 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) April 1, 1998
