Alexion Pharmaceuticals and XOMA Form Collaboration
- Product Development Efforts to Focus on TPO Mimetic Antibody -
CHESHIRE, Conn. and BERKELEY, Calif., Dec. 18 /PRNewswire-FirstCall/ -- Alexion
Pharmaceuticals, Inc. and XOMA Ltd. today announced a collaborative agreement
for the development and commercialization of a rationally designed human c-MPL
agonist antibody to treat chemotherapy-induced thrombocytopenia. The compound
was discovered at Alexion Antibody Technologies (AAT), a wholly owned subsidiary
of Alexion, and is in preclinical development. The c-MPL antibody was designed
to mimic the activity of human thrombopoietin (TPO), a naturally occurring
protein responsible for platelet production. Thrombocytopenia is an abnormal
blood condition in which the number of platelets is reduced, potentially leading
to bleeding complications.
"This collaboration combines XOMA's bacterial cell expression technology and its
strong process development and manufacturing capabilities with Alexion's
expertise in antibody engineering, providing the best development means for this
compound," said Stephen P. Squinto, Ph.D., Executive Vice President and Head of
Research. "This also marks a milestone for AAT and demonstrates the progression
of our pipeline; we are pleased to be moving this antibody forward jointly with
XOMA." "We're enthusiastic about working with Alexion. By collaborating with them, we
gain access to a promising product candidate and Alexion's antibody engineering
and development expertise," John L. Castello, XOMA's Chief Executive Officer,
President and Chairman said. "The c-MPL agonist antibody is particularly well
suited to our process development capabilities, including our bacterial cell
expression system. By combining the strengths of our two companies, we hope to
accelerate getting this product into the clinic and ultimately potential
marketing approval." Under the terms of the agreement, Alexion and XOMA will jointly develop and
commercialize the c-MPL agonist antibody for chemotherapy-induced
thrombocytopenia. The parties will share development and commercialization
expenses, including preclinical and clinical development, manufacturing and
marketing costs world-wide, as well as revenues, generally on a 70-30 basis,
with Alexion retaining the larger portion. In addition, Alexion will receive
payments tied to initiation of the collaboration and achievement of a regulatory
milestone. XOMA will be entitled to royalty payments and milestones related to
its bacterial expression technology. Specific financial terms were not
disclosed. The collaboration will initially focus on preclinical, process
development and scale-up work, with initial clinical testing anticipated in
2005.
About the TPO Mimetic Antibodies The rationally designed human c-MPL agonist antibody is part of a new class of
therapeutic antibodies that function as receptor agonists that can stimulate
their cell target, rather than blocking it, and were created using a rational
design and selection process proprietary to AAT. The first rationally designed
human antibody of this new class was designed to accelerate the return of blood
platelet levels to normal following a toxic assault on the bone marrow, which
commonly results in cancer patients undergoing chemotherapy. The TPO agonist
antibody has been designed to bind to and stimulate the c-MPL receptor on the
surface of platelet precursors and then to stimulate platelet-specific
proliferation with a specificity and activity similar to the body's own natural
platelet hormone, thrombopoietin. However, this antibody lacks any protein
sequences related to native thrombopoietin, providing additional therapeutic
benefit by potentially eliminating the harmful immune responses that have been
associated with recombinant thrombopoietin. Alexion recently presented the
status of its rationally designed human c-MPL agonist program at the American
Society of Hematology Meeting held in December 2003 in San Diego.
Administration of the antibody showed an increase in platelets to normal levels
in an animal model following chemotherapy, without production of neutralizing
antibodies against native thrombopoeitin. An abstract of the presentation, made
by Dr. Yi Wang, PhD., Senior Director of Preclinical sciences at Alexion, is
available at the Society's website, http://www.hematology.org/ About Chemotherapy-induced thrombocytopenia Chemotherapy-induced thrombocytopenia is a disease state where a patient's clot
forming platelets are depleted as a byproduct of treatment with chemotherapeutic
agents. Certain drugs used as chemotherapeutic agents are known to eliminate
cells that are a part of the pathway that leads to formation of platelets.
These cells, known as megakaryocytes, are found in the bone marrow and are the
precursor cells to platelets. Platelets play a critical role in the formation
of blood clots and act by sticking together at the site of a wound to help stop
the blood flow out of the wound. The normal level of platelets usually is in
excess of the level required to support normal clot formation. However,
following chemotherapy, these levels can fall to a level that requires blood
transfusions to protect the patient from excessive bleeding.
About XOMA XOMA develops and manufactures antibody and other protein-based
biopharmaceuticals for disease targets that include cancer, immunological and
inflammatory disorders, and infectious diseases. XOMA's programs include
collaborations with Genentech, Inc. on the RAPTIVA(TM) antibody for psoriasis
(being marketed), psoriatic arthritis (Phase II) and other indications and with
Millennium Pharmaceuticals, Inc. on a recombinant protein, MLN 2222 for reducing
the incidence of post-operative events in coronary artery bypass graft surgery
patients employing cardiopulmonary bypass (Phase I). Bactericidal/permeability-increasing protein (BPI)-derived programs include
NEUPREX(R) in a Phase I/II study to limit complications following pediatric
cardiopulmonary bypass surgery, and XMP.629, a topical formulation of a
BPI-derived compound for acne (Phase I). Other development programs focus on
antibodies and other compounds developed by XOMA for the treatment of cancer and
retinopathies. For more information about XOMA's pipeline and activities,
please visit XOMA's website at http://www.xoma.com/.
About Alexion Alexion is engaged in the discovery and development of therapeutic products
aimed at treating patients with a wide array of severe disease states, including
cardiovascular and autoimmune disorders, inflammation and cancer. Alexion's two
lead product candidates, pexelizumab and eculizumab, are currently undergoing
evaluation in several clinical development programs. Alexion has completed a
Phase III clinical study with pexelizumab in coronary artery bypass graft
surgery patients undergoing cardiopulmonary bypass, and two large Phase II
studies with pexelizumab in acute myocardial infarction patients. The Phase III
trial and Phase II trials were conducted in collaboration with Procter & Gamble
Pharmaceuticals. In addition, eculizumab is in Phase II clinical trials in
rheumatoid arthritis and membranous nephritis, and has completed pilot programs
for the treatment of paroxysmal nocturnal hemoglobinuria and dermatomyositis.
Alexion is engaged in discovering and developing a pipeline of additional
antibody therapeutics targeting severe unmet medical needs, through its wholly
owned subsidiary, Alexion Antibody Technologies, Inc. This press release and
further information about Alexion Pharmaceuticals, Inc. can be found on the
World Wide Web at: http://www.alexionpharm.com/.
Re: XOMA Certain statements contained herein related to the development of the c-MPL
antibody and XOMA's collaborative arrangement with Alexion, 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 future clinical trials (including the design and
progress of clinical trials; safety and efficacy of 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 existing
collaborative relationships, the ability of collaborators and other partners to
meet their obligations, market demand for products, scale-up and marketing
capabilities, competition, XOMA's financing needs and opportunities, share price
volatility, international operations, 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 XOMA's most recent annual report on Form 10-K and in
its other SEC filings.
Re: Alexion This news release contains forward-looking statements. Such statements are
subject to factors that may cause Alexion's results and plans to differ from
those expected, including the results of pre-clinical or clinical studies
(including termination or delay in clinical programs), the need for additional
research and testing, delays in arranging satisfactory manufacturing capability,
inability to acquire funding on timely and satisfactory terms, delays in
developing or adverse changes in commercial relationships, the possibility that
results of earlier clinical trials are not predictive of safety and efficacy
results in later clinical trials, dependence on Procter & Gamble Pharmaceuticals
for development and commercialization of pexelizumab, the risk that third
parties won't agree to license any necessary intellectual property to us on
reasonable terms, and a variety of other risks set forth from time to time in
Alexion's filings with the Securities and Exchange Commission, including but not
limited to the risks discussed in Alexion's Annual Report on Form 10-K for the
year ended July 31, 2003 and in our other filings with the Securities and
Exchange Commission. In particular, Alexion is not currently able to predict the
determination of the United States Food and Drug Administration (FDA) and other
regulatory agencies regarding the results of the PRIMO-CABG trial. Such
determinations may include, but not be limited to, the view that the results may
be sufficient for filing and approval of a Biologics License Application (BLA),
supportive of the filing and approval of a BLA together with additional studies,
or not supportive of the filing or approval of a BLA. Further, Alexion is not
currently able to predict the reaction of P&GP to the results of the PRIMO-CABG
trial, including how those results may affect P&GP's views of pexelizumab for
CABG or other indications. P&GP retains the development rights and the
termination rights discussed in Alexion's Form 10-K referred to above. Alexion
does not intend to update any of these forward-looking statements to reflect
events or circumstances after the date hereof, except when a duty arises under
law.
For Alexion Pharmaceuticals: For XOMA:
Stephen P. Squinto, Ph.D. Laura Zobkiw
Executive Vice President Corporate Communications/
and Head of Research Investor Relations
(203) 272-2596 (510) 204-7273 Rhonda Chiger (Investors)
Rx Communications Group
(917) 322-2569 Ernie Knewitz (Media)
Euro RSCG Life NRP
(212) 845-4253
DATASOURCE: Alexion Pharmaceuticals, Inc.; XOMA Ltd.
CONTACT: Stephen P. Squinto, Ph.D., Executive Vice President and Head of Research of Alexion Pharmaceuticals, Inc., +1-203-272-2596; Rhonda Chiger (Investors) of Rx Communications Group, +1-917-322-2569, or Ernie Knewitz (Media) of Euro RSCG Life NRP, +1-212-845-4253, both for Alexion Pharmaceuticals, Inc.; or Laura Zobkiw, Corporate Communications-Investor Relations, +1-510-204-7273, for XOMA Ltd. Web site: http://www.alexionpharm.com/ http://www.xoma.com/
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