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: November 25, 1996
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
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained on the following
press release dated November 25, 1996.
COMPLETE H. PYLORI GENOME SEQUENCE LICENSED TO
ORAVAX AND PASTEUR MERIEUX CONNAUGHT IN EXCLUSIVE
AGREEMENT WITH MEDIMMUNE AND HUMAN GENOME SCIENCES
FOR DEVELOPMENT OF NOVEL VACCINES
Cambridge, MA; Lyon, France; Gaithersburg, MD; and Rockville, MD,
November 25, 1996 -Vaccine development partners OraVax, Inc.
(Nasdaq:ORVX) and Pasteur Merieux Connaught have entered a research and
licensing agreement with MedImmune (Nasdaq:MEDI) and Human Genome
Sciences (Nasdaq:HGSI) (HGS). Announced jointly by all four companies,
OraVax and Pasteur Merieux Connaught have licensed the complete genome
sequence of Helicobacter pylori (H. pylori) for the development of
vaccines against H. pylori, the bacteria which causes the majority of
cases of duodenal and stomach ulcers and is a major risk factor for
stomach cancer.
Under the terms of the agreement, OraVax and Pasteur Merieux Connaught are
granted an exclusive worldwide license to the complete H. pylori genome
for vaccine development. Under an existing alliance, MedImmune licensed
from HGS the genomic sequences of H. pylori and other bacteria for the
development of new vaccines and immunotherapeutics. Under this
agreement, OraVax and Pasteur Merieux Connaught will have control and
responsibility for filing patents on new molecular discoveries for use in
the development of vaccines againstH. pylori infection.
"This agreement provides access to the most complete and detailed genomic
information and bioinformatics capabilities related to H. pylori
available, significantly strengthening our clinical development program
in the field of H. pylori vaccine development," said Jean-Jacques
Bertrand, President of Pasteur Merieux Connaught and Lance K. Gordon,
Ph.D., President and CEO of OraVax, co-Chairmen of the H. pylori vaccine
partnerships between Pasteur Merieux Connaught and OraVax. "This
information is an important addition to the genomic database we have
already assembled, allowing for rapid confirmation of existing knowledge
as well as accelerated discovery and evaluation of new molecules as
potential vaccine components."
Financial terms of the agreement call for OraVax and Pasteur Merieux
Connaught to make license payments to MedImmune/HGS beginning with
execution of the agreement and upon issuance of the first U.S. patent.
In addition to royalties on any future sales, future milestone payments
will be paid to MedImmune/HGS to reflect attainment of certain product
development and revenue goals.
This H. pylori sequence was determined by a team led by Jean-Francois Tomb,
Ph.D., of The Institute for Genomic Research (TIGR) in Rockville,
Maryland, an affiliate of HGS. Dr. Tomb's team prevailed in the assembly
of all 1.67 megabases of the H. pylori genome. The team then identified
more than 1,600 open reading frames and closed all gaps in the sequences
to complete the genome.
H. pylori infection affects an estimated 30 percent of the U.S. population,
causing more than 5 million cases of peptic ulcer disease per year. In
other parts of the world, the infection and ulcer rates are significantly
higher. The World Health Organization's 1996 World Health Report
estimates that H. pylori is also responsible for 550,000 new cases per
year of stomach cancer worldwide.
"This agreement will serve all parties well, and most importantly, we hope,
will serve patients who suffer from the pathogenic effects of H. pylori,"
said William A. Haseltine, Ph.D., Chairman and CEO of Human Genome
Sciences and Wayne T. Hockmeyer, Ph.D., Chairman and CEO of MedImmune.
"The experience and scientific capability of the OraVax and Pasteur
Merieux Connaught team, and their aggressive commitment to an H. pylori
program are an exciting and valuable complement to the genomic material
and information HGS and TIGR have developed. Naturally, we hope they are
able to develop and launch an H. pylori vaccine rapidly."
OraVax and Pasteur Merieux Connaught have established global partnerships to
develop and commercialize vaccines against H. pylori. The companies
recently completed a Phase II study which demonstrated for the first time
that one antigen, urease, when administered with an adjuvant, could
elicit an immune response and reduce levels of H. pylori infection in
humans. OraVax and Pasteur Merieux Connaught have a proprietary position
on more than 30 potential H. pylori vaccine antigens.
The collaboration between MedImmune and HGS involves the sequencing of
bacterial genomes for the development of vaccines and immunotherapeutic
agents. Prior to today's announcement, the companies have announced the
sequencing and initiation of product development for vaccines against two
bacterial pathogens, non-typeable Haemophilus influenzae, which causes
middle-ear infections in children, and Staphylococcus aureus, a major
hospital infection.
This news release contains forward-looking statements that involve risks and
uncertainties, including product development and commercialization risks,
the risks of satisfying the regulatory approval process in a timely
manner, and other risks detailed in OraVax, HGS and MedImmune filings
with the U.S. Securities and Exchange Commission (SEC).
OraVax, Inc., based in Cambridge, Massachusetts, is a biopharmaceutical
company engaged in the discovery and development of oral vaccines and non-
injected antibody products to prevent or treat diseases which infect the
human body at its mucosal linings.
Pasteur Merieux Connaught, seeks to contribute as the global leader to the
protection and maintenance of human health by creating superior
immunological products for the prevention and treatment of infectious
diseases and cancers. Pasteur Merieux Connaught refers to companies
owned by Pasteur Merieux Serums & Vaccins S.A. of Lyon, France, including
subsidiaries Connaught Laboratories in Canada and the United States,
which are part of the Rhone-Poulenc group.
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 six
new products in clinical trials. MedImmune is located in Gaithersburg,
Maryland.
Human Genome Sciences is a company with the mission to develop products to
predict, prevent, detect, treat and cure disease based on technology
derived from its leadership position in the discovery and understanding
of human, microbial, and plant genes. Human Genome Sciences, Inc. is
based in Rockville, Maryland.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
MEDIMMUNE, INC.
Registrant)
Date: November 25, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
