Tolerx retains rights to type 1 diabetes indication and could earn up to $680 million in development funds and milestone fees for R&D in other diseases.

GlaxoSmithKline and Tolerx are collaborating to further the latter’s Phase II mAb that reportedly has the potential to treat autoimmune and immune-mediated inflammatory diseases. Tolerx will initially receive $70 million and could make up to $680 million with various milestone achievements.

Tolerx will advance this humanized anti-CD3 mAb called otelixizumab (TRX4), which has completed Phase II studies in type 1 diabetes, into late-stage trials and will file a BLA for the compound. The company has the option to copromote otelixizumab for this indication in the U.S.

GSK has exclusive rights to develop and commercialize otelixizumab in all other indications in the rest of the world. The firm also has the exclusive right to develop the pediatric indication for type 1 diabetes in the U.S.

As part of the collaboration, Tolerx will receive an upfront payment, equity, and advance R&D funding totaling $70 million. The company may earn up to $155 million in future development costs of otelixizumab in type 1 diabetes. GSK could tender up to $350 million in milestone fees related to all indications.

Tolerx may also get up to $175 million in milestone payments based on tiered net sale thresholds of otelixizumab. The company will be entitled to receive tiered, double-digit royalty payments on worldwide sales of otelixizumab in all indications.

At the time of an IPO of Tolerx’ common stock and at the request of Tolerx and certain other conditions, GSK will invest up to an additional $10 million in the company.

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