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: February 26, 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 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 February 25, 1999:
MEDIMMUNE AND IXSYS ENTER FOUR PRODUCT ANTIBODY ALLIANCE
- - Lead Product in Phase 2 for Cancer Treatment by Inhibition of Angiogenesis
-
Gaithersburg, MD, and San Diego, CA, February 25, 1999 - MedImmune, Inc.
(Nasdaq:MEDI) and Ixsys, Inc. today announced that they have formed an
alliance to develop four monoclonal antibodies. The lead product, a
humanized monoclonal antibody known as Vitaxin (trademark), was developed by
Ixsys using its proprietary Directed Evolution technology and is currently
being tested in a Phase 2 trial for cancer treatment by inhibition of
angiogenesis. MedImmune will provide three additional target antibodies to
be optimized by Ixsys. Under the terms of the alliance, Ixsys will use its
Directed Evolution protein engineering technology to optimize antibodies
identified by MedImmune, and MedImmune will be responsible for clinical
development, manufacturing and commercialization of any resulting products.
MedImmune is making a $6.4 million equity investment in Ixsys, will fund
certain research to be performed by Ixsys and will make future milestone and
royalty payments on sales of any resulting products. The total value of the
collaboration to Ixsys, not including potential royalties, could be as high
as $50 million.
"The work done by Ixsys and its collaborators with Vitaxin (trademark) is
some of the most exciting and progressive we have seen in the rapidly
developing field of angiogenesis," said Scott Koenig, M.D., Ph.D., Vice
President of Research at MedImmune. "Vitaxin (trademark) appears to inhibit
a key pathway involved in the formation of new blood vessels, and may provide
a way to combat the growth and spread of solid tumors. Additionally, Vitaxin
(trademark) may have use in other diseases that require angiogenesis, such as
macular degeneration, diabetic retinopathy, rheumatoid arthritis, and
restenosis following angioplasty."
Angiogenesis is the growth of new blood vessels from pre-existing cells. In
solid tumors, angiogenesis allows new blood vessels to grow into solid tumor
tissue, providing the growing tumor both a means of nutrient and oxygen
uptake, and a possible route for tumor metastasis into other organs. During
angiogenesis, the solid tumor secretes growth factors which cause blood
vessel-forming endothelial cells to multiply and extend toward the solid
tumor. These cells use a family of proteins called integrins to adhere to
the surrounding tissue, allowing them to continue their extension toward the
tumor. Vitaxin (trademark) has been shown to bind to the integrin, called
alpha-v beta-3 (also known as the vitronectin receptor), specifically found
on newly sprouting blood vessels and to stop the growth of these vessels
through an apoptotic (programmed cell death) signaling mechanism. This
inhibition of new blood vessel formation has been shown to block the growth
and spread of solid tumors in various animal models.
Ixsys recently completed a Phase 1 clinical trial to assess the safety of
Vitaxin (trademark) in patients with incurable malignant cancer. In this
trial, Vitaxin (trademark) was found to be generally safe and well-tolerated.
Of the fourteen evaluable patients, eight experienced stabilization of their
disease of which one experienced a reduction in tumor size. The company has
also completed a Phase 1/2 imaging study at the University of Alabama, and
recently initiated a Phase 2 study in leiomyosarcoma patients at the M.D.
Anderson Cancer Center. Plans for additional clinical trials in
glioblastoma, breast or colon cancer, and rheumatoid arthritis patients are
currently being developed. Using its Directed Evolution technology, Ixsys
has recently developed a second generation variant of Vitaxin (trademark)
with significantly increased potency and production advantages. MedImmune
intends to complete development of the second generation variant of Vitaxin
(trademark) prior to commencing pivotal studies.
"Our work with human tumor tissue in animal models at The Scripps Research
Institute has clearly demonstrated the ability of Vitaxin (trademark) to
inhibit solid tumor growth and metastasis," said David A. Cheresh, Ph.D., of
The Scripps Research Institute and the discoverer of the role of alpha-v beta-
3 integrin in angiogenesis. "We have also shown the critical role of the
alpha-v beta-3 integrin in ocular neovascular diseases, such as macular
degeneration and proliferative diabetic retinopathy. The potential for
Vitaxin (trademark) to inhibit this angiogenic pathway has far reaching
implications in clinical medicine."
Vitaxin (trademark) was developed by Ixsys based on the initial discoveries
made by Dr. Cheresh and his colleagues at The Scripps Research Institute with
a precursor murine antibody known as LM609. Ixsys humanized and optimized
the original murine antibody developed by Dr. Cheresh using its protein
engineering technology called Directed Evolution. Directed Evolution
provides a quick and efficient method of protein discovery and optimization
and allows Ixsys to increase the binding affinity of proteins by combining
the efficient creation of new protein variations with new approaches to
screen and select the best variations.
"Vitaxin (trademark) is an important new product opportunity for MedImmune
which fits directly into our proven strengths in antibody development and
production, clinical research, and hospital sales," said David M. Mott,
MedImmune's Vice Chairman and Chief Financial Officer. "It also provides us
with an opportunity to begin to expand from our historical base in infectious
disease and transplantation to the field of oncology, which we have long
viewed as a future growth area for the company." Mr. Mott added that "the
breadth of the potential indications for Vitaxin (trademark) as well as the
ability to apply Ixsys' proprietary antibody engineering technology to
additional antibody targets, provides the potential for very significant
value creation for both MedImmune and Ixsys."
"We believe that MedImmune's proven ability to develop and commercialize
antibodies makes them an ideal partner for Ixsys," added William D. Huse,
M.D., Ph.D., Chief Executive Officer and Chief Scientific Officer at Ixsys.
"We are excited about the opportunity to work with MedImmune to commercialize
our novel anti-angiogenic antibody, Vitaxin (trademark), and to apply our
antibody engineering technology to the development of additional antibodies
for MedImmune."
Ixsys, located in San Diego, California, is a privately held
biopharmaceutical company engaged in the development of novel therapeutics.
Ixsys' Directed Evolution technology is centered around the Kauffman and
Codon-Based Mutagenesis patents, which form the foundation of the Company's
broad discovery and protein engineering capabilities. Specifically, this
enabling platform provides Ixsys with a valuable and efficient solution for
discovering and optimizing proteins with commercial potential for both itself
and its partners. To date, the company has successfully engineered
monoclonal antibodies in collaboration with pharmaceutical partners, and in-
licensed and engineered several molecules for itself, including Vitaxin
(trademark).
MedImmune, located in Gaithersburg, Maryland, is a biotechnology company
which currently markets three products through its hospital-based sales force
and has five new product candidates in clinical trials.
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 the 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) February 26, 1999
