GSK and Tolerx in global diabetes and autoimmune tie up

UK-headquartered GlaxoSmithKline (GSK) and US-based biopharmaceutical company Tolerx have revealed a global alliance to develop and commercialise otelixizumab (TRX4), a novel humanised anti-CD3 monoclonal antibody for autoimmune and immune-mediated inflammatory diseases, including type I 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 preserved the function of insulin-producing beta cells in the pancreas in patients with type I diabetes, reducing the amount of administered insulin needed to control blood glucose levels.

Per the agreement, Tolerx will run a phase III clinical programme for type 1 diabetes in the US up to and including regulatory submission of the biologics license application (BLA). The company also 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 commercialise the monoclonal antibody in all other indications in the rest of the world. GSK also has the exclusive right to develop the paediatric indication for type 1 diabetes in the US.

Tolerx will receive an upfront payment, equity and advance R&D funding of USD 70m.  The company could also receive up to USD 155m in future development costs of otelixizumab in type I diabetes and earn approximately USD 350m in milestone payments for otelixizumab in type I diabetes and multiple additional indications. USD 175m may also be available in sales milestone payments based on tiered net sales thresholds of otelixizumab.

Tolerx will receive tiered, double-digit royalty payments on worldwide sales of otelixizumab in all indications. At the time of an initial public offering (IPO) of Tolerx's common stock and at the request of Tolerx and certain other conditions, GSK will invest up to an additional USD 10m in Tolerx's common stock.

Dr Moncef Slaoui, chairman of R&D at GSK, said: "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."

Dr Douglas J Ringler, Tolerx's CEO, said: "GSK brings a wealth of experience, expertise, and global resources to this collaboration. The agreement with GSK provides the infrastructural support required to advance our goal of being first-to-market with otelixizumab in type I 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."