GSK, Tolerx Collaborate on Anti-CD3 MAb

GlaxoSmithKline and Tolerx, Inc. have formed 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.

Tolerx will have responsibility for the Phase III clinical program for type 1 diabetes in the U.S. as far as and including regulatory submission of the BLA. Tolerx has the option to co-promote otelixizumab in type 1 diabetes in the U.S. with GSK, while GSK will have exclusive rights to develop and commercialize it 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 U.S.

Tolerx will receive an upfront payment, equity and advance R&D funding totaling $70 million. In addition, Tolerx may receive as much as $155 million in future development costs of otelixizumab in type 1 diabetes, and may earn as much as $350 million in milestone payments, assuming successful development and approvals of otelixizumab for type 1 diabetes and multiple additional indications. Tolerx may also receive as much as $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.

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.