XOMA
FOR IMMEDIATE RELEASE
Contacts:
XOMA Millennium Pharmaceuticals, Inc.
Investors: Laura Zobkiw (Tel: 510-204-7273) Investors: Gina Nugent (617-551-3611)
Media: Deb McManus (Tel: 510-204-7240) Media: Adriana Jenkins (617-761-6776)
MILLENNIUM AND XOMA ANNOUNCE RESTRUCTURING
OF COLLABORATION AGREEMENT
FOR THE DEVELOPMENT OF MLN2222
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CAMBRIDGE, MA and BERKELEY, CA, October 12, 2004 - Millennium Pharmaceuticals,
Inc. (NASDAQ:MLMN) and XOMA Ltd. (NASDAQ: XOMA) today announced the
restructuring of their agreement related to the collaboration for the
development of MLN2222, currently being investigated in a phase I clinical trial
for Coronary Artery Bypass Graft (CABG) surgery. This agreement supersedes the
Companies' previous development and investment agreements, established in
November, 2001. Key elements of the new, restructured relationship include:
o XOMA will be responsible for development work and expenses related to
MLN2222 through completion of the ongoing phase I clinical trial.
Millennium will assume responsibility for all subsequent development
work and expenses for MLN2222 at initiation of phase II testing. Under
terms of the original agreement, XOMA was responsible for development
work and expenses through phase II testing.
o XOMA will continue to provide quantities of bulk drug substance
requested by Millennium at the expense of Millennium for phase II
trials.
o XOMA will be entitled to receive an undisclosed royalty on future net
sales of MLN2222, as well as payments related to the achievement of
clinical and regulatory milestones. Under terms of the original
agreement, XOMA had the option of either entering into a cost and
profit sharing arrangement through phase III clinical trials and
commercialization or a milestone and royalty arrangement.
o The investment agreement between Millennium and XOMA is terminated and
there will be no further issuance of XOMA common shares to Millennium.
"We believe that MLN2222 is a promising molecule to provide protection against
complications associated with coronary artery bypass surgery," said John L.
Castello, chairman, president and chief executive officer of XOMA. "This new
arrangement provides advantages to both companies and is consistent with XOMA's
increasing focus in oncology, autoimmune and inflammatory diseases."
"MLN2222 has an exciting mechanism of action, and on the completion of the phase
I study, we will analyze the data and evaluate our next steps with the
molecule," said Nancy Simonian, M.D., senior vice president of clinical
development. "We are delighted to continue our supply agreement with XOMA to
ensure our development timelines remain on track."
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XOMA
About MLN2222
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MLN2222 (also known as CAB-2) is a novel, proprietary recombinant protein that
blocks both the C3 and C5 convertases, which are essential components of the
complement activation pathway. Complement activation is believed to contribute
to harmful inflammatory responses to heart bypass surgery that can result in
significant complications. MLN2222 is being developed to reduce the incidence of
death and heart attacks in patients undergoing procedures involving the use of
cardiopulmonary bypass (CPB), a heart-lung bypass machine.
The complement system plays a central role in stimulating the body's immune
functions in addition to regulating inflammatory responses. The complement
system is also an important defense mechanism against bacterial infections.
However, complement activation can cause many acute and chronic inflammatory
disorders, leading to tissue injury and greater incidence of postoperative death
and myocardial infarction in patients undergoing CPB. By blocking the two key
pathways of complement activation (the C3 and C5 convertases) early within the
complement cascade, MLN2222 may reduce tissue injury in multiple organ systems,
reducing the mortality and morbidity associated with CABG surgery employing CPB.
About Millennium
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Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in
Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, a novel cancer
product, co-promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading
cardiovascular product, and has a robust clinical development pipeline of
product candidates. The Company's research, development and commercialization
activities are focused in three therapeutic areas: oncology, cardiovascular, and
inflammation. By applying its knowledge of the human genome, its understanding
of disease mechanisms, and its industrialized drug discovery platform, the
Company is seeking to develop breakthrough products.
About XOMA
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XOMA is a biopharmaceutical company focused on the development and
commercialization of antibody and other protein-based biopharmaceuticals for
disease targets that include cancer, immunological and inflammatory disorders,
and infectious diseases. XOMA's proprietary and collaborative product
development programs include: RAPTIVA(R) for moderate to severe plaque psoriasis
(marketed) and other indications in collaboration with Genentech, Inc.; MLN
2222, a recombinant protein for reducing the incidence of post-operative events
in coronary artery bypass graft surgery patients with Millennium
Pharmaceuticals, Inc. (Phase I); CHIR-12.12, an anti-CD40 antibody for treating
B-cell tumors and additional product candidates in connection with the antibody
oncology collaboration with Chiron Corporation (preclinical); a TPO mimetic
antibody to treat chemotherapy-induced thrombocytopenia in collaboration with
Alexion Pharmaceuticals, Inc. (preclinical); and several anti-gastrin product
candidates in conjunction with the antibody collaboration for the treatment of
gastrointestinal cancers with Aphton Corporation (preclinical). XOMA's
proprietary bactericidal/permeability-increasing protein (BPI)-derived programs
include NEUPREX(R), in a Phase I/II study to limit complications following
pediatric cardiopulmonary bypass surgery. For more information about XOMA's
product pipeline and antibody product development capabilities and technologies,
please visit XOMA's website at http://www.xoma.com/.
Re: Millennium
This press release contains "forward-looking statements," including statements
about our growth and future operating results, discovery and development of
products, potential acquisitions, strategic alliances and intellectual property.
Various important risks may cause the Company's actual results to differ
materially from the results indicated by these forward-looking statements,
including: adverse results in our drug discovery and clinical development
programs; failure to obtain patent protection for our discoveries; commercial
limitations imposed by patents owned or controlled by third parties; our
dependence upon strategic alliance partners to develop and commercialize
products and services based on our work; difficulties or delays in obtaining
regulatory approvals to market products and services resulting from our
development efforts; the commercial success of VELCADE(R) (bortezomib) for
Injection and INTEGRILIN(R) (eptifibatide) Injection; and the requirement for
substantial funding to
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conduct research and development and to expand commercialization activities. For
a further list and description of the risks and uncertainties we face, see the
reports we have filed with the Securities and Exchange Commission. We disclaim
any intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Re: XOMA
Certain statements contained herein related to the progress and timing of
product development or present or future licensing, collaborative or financing
arrangements or that otherwise relate to future periods, are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These statements are based
on assumptions that may not prove accurate. Actual results could differ
materially from those anticipated due to certain risks inherent in the
biotechnology industry and for companies engaged in the development of new
products in a regulated market. These and other risks, including those related
to the results of pre-clinical testing, the timing or results of pending and
future clinical trials (including the design and progress of clinical trials;
safety and efficacy of the products being tested; action, inaction or delay by
the FDA, European or other regulators or their advisory bodies; and analysis or
interpretation by, or submission to, these entities or others of scientific
data), changes in the status of the existing collaborative relationships,
availability of additional licensing or collaboration opportunities, the ability
of collaborators and other partners to meet their obligations, market demand for
products, scale up and marketing capabilities, competition, international
operations, share price volatility, XOMA's financing needs and opportunities,
uncertainties regarding the status of biotechnology patents, uncertainties as to
the cost of protecting intellectual property and risks associated with XOMA's
status as a Bermuda company, are described in more detail in the Company's most
recent annual report on Form 10K and in other SEC filings.
Editor's Note: This release is available under the Media section on the
Company's website at www.millennium.com. and under the News and Events section
on XOMA's website at www.xoma.com.
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