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GlaxoSmithKline (GSK) and Tolerx, Inc. Form Collaboration
Worth Up to $700 Million
LONDON and CAMBRIDGE, Mass., Oct. 23, 2007 /PRNewswire-FirstCall/
-- GlaxoSmithKline (NYSE: GSK - News) and Tolerx, Inc. today
announced the execution of a worldwide alliance to develop and
commercialize otelixizumab (TRX4), a novel humanized anti-CD3
monoclonal antibody that has potential across a broad range of
autoimmune and immune-mediated inflammatory diseases, including
type 1 diabetes. Otelixizumab has been evaluated in type 1
diabetes in two Phase II studies and in psoriasis in two Phase I
studies. In clinical trials, otelixizumab has been shown to
preserve the function of insulin-producing beta cells in the
pancreas in patients with type 1 diabetes, reducing the amount
of administered insulin needed to control blood glucose levels.
Under the terms of the agreement, Tolerx will have
responsibility for the Phase III clinical program for type 1
diabetes in the US up to and including regulatory submission of
the biologics license application (BLA). Tolerx has the option
to co-promote otelixizumab in type 1 diabetes in the US with GSK,
while GSK will have exclusive rights to develop and
commercialize otelixizumab in all other indications in the rest
of the world. GSK also has the exclusive right to develop the
pediatric indication for type 1 diabetes in the US.
As part of the collaboration, Tolerx will receive an upfront
payment, equity and advance R&D funding totaling $70 million. In
addition, Tolerx may receive up to $155 million in future
development costs of otelixizumab in type 1 diabetes. Tolerx may
earn up to $350 million in milestone payments, assuming
successful development and approvals of otelixizumab for type 1
diabetes and multiple additional indications. Tolerx may also
receive up to $175 million in sales milestone payments based on
tiered net sales thresholds of otelixizumab. Tolerx will be
entitled to receive tiered, double-digit royalty payments on
worldwide sales of otelixizumab in all indications. At the time
of an initial public offering of Tolerx's common stock and at
the request of Tolerx and certain other conditions, GSK will
invest up to an additional $10 million in Tolerx's common stock.
Dr. Moncef Slaoui, Chairman of Research and Development at GSK,
commented, "Otelixizumab is another welcome addition to GSK's
rapidly expanding biopharmaceuticals pipeline. This is a key
area of future growth and investment for GSK and, as a novel
treatment for many T cell-mediated diseases, the potential of
otelixizumab is significant. Together with Tolerx, who are
pioneers in this area of science, we hope to realize the
potential of this compound and bring a valuable new treatment
option to patients suffering from type 1 diabetes and other
autoimmune disorders."
"GSK brings a wealth of experience, expertise, and global
resources to this collaboration. The agreement with GSK enables
us to operationally leverage Tolerx's expertise in therapeutic
immune regulation, expand the development of otelixizumab in
type 1 diabetes and other indications, and capitalize on GSK's
considerable worldwide development, regulatory, and
commercialization infrastructure and experience," said Dr.
Douglas J. Ringler, President and Chief Executive Officer of
Tolerx. "Moreover, it provides the infrastructural support
required to advance our goal of being first-to-market with
otelixizumab in type 1 diabetes. We anticipate the collaboration
will allow the potential of this novel therapy to be fully
explored globally, not only for the treatment of patients with
type 1 diabetes but also for those with autoimmune disorders for
which the current standard of care is inadequate."
About Type 1 Diabetes
Diabetes (medically known as diabetes mellitus) is the name
given to disorders in which the body has difficulty regulating
its blood glucose, or blood sugar, levels. There are two major
types of diabetes: type 1 and type 2. Type 1, also called
juvenile diabetes or insulin-dependent diabetes, is a disorder
of the body's immune system. In type 1 diabetes, the pancreas
produces little or no insulin as a result of the immune system
attacking and destroying the insulin-producing beta cells in the
pancreas. Therefore, type 1 diabetes patients require frequent
administration of insulin therapy each day to control their
blood sugar levels.
About Otelixizumab
Otelixizumab is a monoclonal antibody that binds to a receptor
component found on all T cells known as CD3, which is involved
in normal T cell signaling. Otelixizumab is designed to block
the function of autoreactive T-effector cells that attack the
body's tissues and cause autoimmune disease while inducing a
subset of T cells called T-regulatory cells that are thought to
protect against T-effector cell damage well after the drug has
been eliminated from the body. In a Phase II clinical study of
subjects with new-onset type 1 diabetes, otelixizumab
demonstrated the potential to preserve the function of
insulin-producing beta cells in the pancreas and reduce the
amount of administered insulin needed to control blood glucose
levels for up to 18 months after only a single six day course of
therapy. In the study, residual betacell function was assessed
by measuring glucose clamp-induced C-peptide release before and
after the administration of glucagon. Otelixizumab
administration was associated with transient symptoms of
flu-like syndrome and transient Epstein-Barr Virus (EBV)
reactivation. Tolerx has completed dose optimization studies in
subjects with type 1 diabetes and psoriasis and has identified a
dosing regimen that thus far has significantly reduced or
eliminated these side effects while maintaining important
biological activity.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to
improving the quality of human life by enabling people to do
more, feel better and live longer. For more information, visit
GlaxoSmithKline at
www.gsk.com.
About Tolerx
Tolerx is a biopharmaceutical company engaged in the discovery
and development of novel therapies to treat patients with
immune-mediated diseases. Tolerx currently has two antibodies in
clinical development: otelixizumab in type 1 diabetes and
psoriasis, and TRX1 in cutaneous lupus erythematosus (CLE). TRX1
is a humanized anti-CD4 antibody that is being developed in
collaboration with Genentech, Inc. Tolerx is also engaged in
preclinical development of new product candidates that induce
immunological tolerance for the treatment of autoimmune diseases
and circumvent tolerance for the treatment of cancer or chronic
viral diseases. For more information, please visit
www.tolerx.com.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK's operations
are described under 'Risk Factors' in the Operating and
Financial Review and Prospects in the company's Annual Report on
Form 20-F for 2006.
Tolerx Forward-Looking Statements
This press release contains certain statements that are preceded
by, followed by, or that include the words "will," "may," "if,"
"assuming" or similar expressions or the negation thereof. Such
statements, which are not historical facts, constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995 (the "Reform Act").
Statements regarding GSK's financing commitment to Tolerx, the
potential value of payments that may be received by Tolerx
pursuant to the agreement with GSK, and the anticipated progress
and development of otelixizumab, in type 1 diabetes and other
disease indications, are all forward-looking statements. Such
forward-looking statements involve risks, uncertainties and
other factors that may cause the actual performance or
achievements of Tolerx to be materially different from any
future results, performance, or achievements expressed or
implied by such forward-looking statements. Factors and risks
that may affect the forward-looking statements include the
ability of the parties to collaborate successfully to develop
the product candidates, results of future clinical studies, the
ability to obtain regulatory approvals for otelixizumab for type
1 diabetes or any other indication, and the introduction of
competing therapies by other companies. These statements reflect
the view of Tolerx as of the date of this press release, and
Tolerx undertakes no obligation to update or revise any
forward-looking statements to reflect events or circumstances
after the date of this press release.
Source
GlaxoSmithKline
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