Collaboration Focuses on Type 1 Diabetes and Other Autoimmune Indications
LONDON and CAMBRIDGE, Mass., Oct. 23 /PRNewswire-FirstCall/ --
GlaxoSmithKline (NYSE: GSK) 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 http://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 http://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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Related links:
http://www.gsk.com
http://www.tolerx.com
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CONTACT:
GlaxoSmithKline Enquiries: UK Media
enquiries: Philip Thomson, Alice Hunt, Joss Mathieson, or Claire
Brough, 020-8047-5502; US Media enquiries: Nancy Pekarek,
+1-215-751-7709, or Mary Anne Rhyne, +1-919-483-2839; European
Analyst - Investor enquiries: David Mawdsley, 020-8047-5564, or
Sally Ferguson, 020-8047-5543; US Analyst - Investor enquiries:
Frank Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419;
Tolerx Enquiries: CEO: Douglas J Ringler, +1-617-452-1322, CFO:
Tom Shea, +1-617-452-1328, or Media Contact: Melissa Hill,
+1-619-849-6004
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