24th Oct 2007 16:07
BTG PLC24 October 2007 BTG licensee Tolerx forms collaboration with GlaxoSmithKline to develop andcommercialise TRX4 London, UK, 24 October 2007: BTG plc (LSE: BGC), the life sciences company,announces that its licensee, Tolerx, Inc. and GlaxoSmithKline have formed analliance to develop and commercialise the humanised anti-CD3 monoclonal antibodyTRX4 (otelixizumab) for type 1 diabetes and other autoimmune and immune-mediatedinflammatory diseases. BTG will receive a payment of $10m, being the relevant share of the initial $70mto be received by Tolerx. Furthermore, BTG is entitled under the terms of itslicence agreement with Tolerx to receive 50% of any future milestone paymentsreceived by Tolerx in respect of the successful development, approval andcommercialisation of TRX4 in all indications. BTG also has rights to receiveroyalties on product sales. BTG will share around half of any amounts received with the original sources ofthe licensed patents. Louise Makin, BTG's CEO, commented: "We have been excited by the progress madeby Tolerx in developing TRX4 in type 1 diabetes and psoriasis, and are delightedthat they have attracted a world class partner in GlaxoSmithKline with which tomove TRX4 forward, potentially in a broad range of disease indications." The text of the announcement by GlaxoSmithKline and Tolerx follows. GlaxoSmithKline And Tolerx Form Worldwide Collaboration For Development AndCommercialization Of Novel Medication Collaboration Focuses on Type 1 Diabetes and Other Autoimmune Indications London, UK and Cambridge, MA - October 23, 2007 -GlaxoSmithKline and Tolerx,Inc. today announced the execution of a worldwide alliance to develop andcommercialize otelixizumab (TRX4), a novel humanized anti-CD3 monoclonalantibody that has potential across a broad range of autoimmune andimmune-mediated inflammatory diseases, including type 1 diabetes. Otelixizumabhas been evaluated in type 1 diabetes in two Phase II studies and in psoriasisin two Phase I studies. In clinical trials, otelixizumab has been shown topreserve the function of insulin-producing beta cells in the pancreas inpatients with type 1 diabetes, reducing the amount of administered insulinneeded to control blood glucose levels. Under the terms of the agreement, Tolerx will have responsibility for the PhaseIII clinical program for type 1 diabetes in the US up to and includingregulatory submission of the biologics license application (BLA). Tolerx has theoption to co-promote otelixizumab in type 1 diabetes in the US with GSK, whileGSK will have exclusive rights to develop and commercialize otelixizumab in allother indications in the rest of the world. GSK also has the exclusive right todevelop the pediatric indication for type 1 diabetes in the US. As part of the collaboration, Tolerx will receive an upfront payment, equity andadvance 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 successfuldevelopment and approvals of otelixizumab for type 1 diabetes and multipleadditional indications. Tolerx may also receive up to $175 million in salesmilestone payments based on tiered net sales thresholds of otelixizumab. At thetime of an initial public offering of Tolerx's common stock and at the requestof Tolerx and certain other conditions, GSK will invest up to an additional $10million 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 expandingbiopharmaceuticals pipeline. This is a key area of future growth and investmentfor GSK and, as a novel treatment for many T cell-mediated diseases, thepotential of otelixizumab is significant. Together with Tolerx, who are pioneersin this area of science, we hope to realize the potential of this compound andbring a valuable new treatment option to patients suffering from type 1 diabetesand other autoimmune disorders." "GSK brings a wealth of experience, expertise, and global resources to thiscollaboration. The agreement with GSK enables us to operationally leverageTolerx's expertise in therapeutic immune regulation, expand the development ofotelixizumab in type 1 diabetes and other indications, and capitalize on GSK'sconsiderable worldwide development, regulatory, and commercializationinfrastructure and experience," said Dr. Douglas J. Ringler President and ChiefExecutive Officer of Tolerx. "Moreover, it provides the infrastructural supportrequired to advance our goal of being first-to-market with otelixizumab in type1 diabetes. We anticipate the collaboration will allow the potential of thisnovel therapy to be fully explored globally, not only for the treatment ofpatients with type 1 diabetes but also for those with autoimmune disorders forwhich the current standard of care is inadequate." About Type 1 Diabetes Diabetes (medically known as diabetes mellitus) is the name given to disordersin 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, alsocalled juvenile diabetes or insulin-dependent diabetes, is a disorder of thebody's immune system. In type 1 diabetes, the pancreas produces little or noinsulin as a result of the immune system attacking and destroying theinsulin-producing beta cells in the pancreas. Therefore, type 1 diabetespatients require frequent administration of insulin therapy each day to controltheir blood sugar levels. About Otelixizumab Otelixizumab is a monoclonal antibody that binds to a receptor component foundon 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 cellsthat attack the body's tissues and cause autoimmune disease while inducing asubset of T cells called T-regulatory cells that are thought to protect againstT-effector cell damage well after the drug has been eliminated from the body. Ina Phase II clinical study of subjects with new-onset type 1 diabetes,otelixizumab demonstrated the potential to preserve the function ofinsulin-producing beta cells in the pancreas and reduce the amount ofadministered insulin needed to control blood glucose levels for up to 18 monthsafter only a single six day course of therapy. In the study, residual beta cellfunction was assessed by measuring glucose clamp-induced C-peptide releasebefore and after the administration of glucagon. Otelixizumab administration wasassociated with transient symptoms of flu-like syndrome and transientEpstein-Barr Virus (EBV) reactivation. Tolerx has completed dose optimizationstudies in subjects with type 1 diabetes and psoriasis and has identified adosing regimen that thus far has significantly reduced or eliminated these sideeffects while maintaining important biological activity. About GlaxoSmithKline GlaxoSmithKline is one of the world's leading research-based pharmaceutical andhealthcare companies and is committed to improving the quality of human life byenabling 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 developmentof novel therapies to treat patients with immune-mediated diseases. Tolerxcurrently has two antibodies in clinical development: otelixizumab in type 1diabetes and psoriasis, and TRX1 in cutaneous lupus erythematosus (CLE). TRX1 isa humanized anti-CD4 antibody that is being developed in collaboration withGenentech, Inc. Tolerx is also engaged in preclinical development of new productcandidates that induce immunological tolerance for the treatment of autoimmunediseases and circumvent tolerance for the treatment of cancer or chronic viraldiseases. For more information, please visit www.tolerx.com. GlaxoSmithKline Forward-Looking Statements Under the safe harbor provisions of the U.S. Private Securities LitigationReform Act of 1995, GSK cautions investors that any forward-looking statementsor projections made by GSK, including those made in this announcement, aresubject to risks and uncertainties that may cause actual results to differmaterially from those projected. Factors that may affect GSK's operations aredescribed under 'Risk Factors' in the Operating and Financial Review andProspects 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, followedby, or that include the words "will" "may," "if," "assuming" or similarexpressions or the negation thereof, Such statements, which are not historicalfacts, constitute "forward-looking statements" within the meaning of the PrivateSecurities Litigation Reform Act of 1995 (the "Reform Act"). Statementsregarding GSK's financing commitment to Tolerx, the potential value of paymentsthat may be received by Tolerx pursuant to the agreement with GSK, and theanticipated progress and development of otelixizumab, in type 1 diabetes andother disease indications, are all forward-looking statements. Suchforward-looking statements involve risks, uncertainties and other factors thatmay cause the actual performance or achievements of Tolerx to be materiallydifferent from any future results, performance, or achievements expressed orimplied by such forward-looking statements. Factors and risks that may affectthe forward-looking statements include the ability of the parties to collaboratesuccessfully to develop the product candidates, results of future clinicalstudies, the ability to obtain regulatory approvals for otelixizumab for type Idiabetes or any other indication, and the introduction of competing therapies byother companies. These statements reflect the view of Tolerx as of the date ofthis press release, and Tolerx undertakes no obligation to update or revise anyforward-looking statements to reflect events or circumstances after the date ofthis press release. For further information contact: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 About BTG BTG in-licenses, develops and commercialises pharmaceuticals and other medicaltechnologies. With a substantial and growing revenue stream of royalties andmilestone payments from out-licensed products, BTG continues to strengthen itspipeline of preclinical and clinical development programmes. Active in thefields of oncology, diseases of ageing, neuroscience, drug repositioning andmedical devices, BTG works from its offices in London, Philadelphia and Osakawith a global partner network of healthcare companies and researchorganisations. For further information, visit: www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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