GSK, Tolerx forge $760M development pact

Tolerx has scored a Big Pharma partner in its race to develop a monoclonal antibody (MAb) that may protect people from autoimmune disease. Its chief competitor in the race is MacroGenics, which just days ago announced its licensing deal with Eli Lilly for teplizumab. Both companies are advancing an anti-CD3 monoclonal antibody. Tolerx says that its MAb binds to the CD3 receptor on T cells, blocking a function of T-effector cells that cause autoimmune disease. The biotech has struck its deal with GlaxoSmithKline right at the sweet spot in the deal-making calendar: Tolerx has its therapy--otelixizumab--headed into Phase III trials for type 1 diabetes. Mid-stage trials demonstrated its effectiveness in lowering the need for insulin therapy. The therapy has also been studied in two Phase I trials in psoriasis.

Under the terms of the deal, Tolerx gets $70 million in upfront fees, equity and advanced R&D funds, up to $155 million in future development costs, $350 million in scheduled milestones for a successful program and $175 million in sales milestones. As a further sweetener, Glaxo will invest up to $10 million in Tolerx stock when it goes public. Tolerx will be responsible for a late-stage study of the therapy for type 1 diabetes through the biologics license application. Tolerx also keeps an option to co-promote the therapy for type 1 in the U.S. while Glaxo gains exclusive rights to all other indications in the rest of the world.

"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," says Dr. Moncef Slaoui, chairman of research and development at GSK.

- see the release for more info

ALSO: For more on Tolerx and its race with MacroGenics, read this profile.

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