GSK enters global TRX4 alliance with Tolerx

UK drug major GlaxoSmithKline and USA-based Tolerx have entered 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. The agent has already been evaluated in type 1 diabetes in two Phase II studies and in psoriasis in two Phase I trials. In the clinic, it 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, Tolerx noted.

Under the terms of the agreement, the US firm will have responsibility for the Phase III clinical program for type 1 diabetes in the USA, up to and including regulatory submission of the biologics license application. Tolerx has the option to co-promote the agent in this indication in the USA with GSK, while the latter will have exclusive rights to develop and commercialize otelixizumab as a treatment for other diseases in the rest of the world. The UK drugmaker also has the exclusive right to develop the pediatric indication for type 1 diabetes in the USA.

As part of the collaboration, Tolerx will receive an upfront payment, equity and advance R&D funding totaling $70.0 million, as well as up to $155.0 million in development costs for the type 1 diabetes indication. The firm may also earn up to $350.0 million in milestones, assuming successful development and approvals for multiple additional indications, and up to $175.0 million in sales milestones based on tiered revenue thresholds, as well as tiered, double-digit royalty payments on worldwide sales of otelixizumab in all indications. At the time of an initial public offering of Tolerx,' GSK may also invest up to $10.0 million in the firm's common stock.