GSK, Tolerx forge $760M development pact

Tolerx has scored a Big Pharma partner in its race to develop a monoclonal antibody [1] (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 [2] 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 [3] for more info

ALSO: For more on Tolerx and its race with MacroGenics, read this profile [4].

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