Transition Therapeutics licenses diabetes regenerative therapy to Novo Nordisk

Toronto-based biopharmaceutical company Transition Therapeutics has signed a licensing agreement with Novo Nordisk to develop Islet Neogenesis Therapy (INT) for the treatment of diabetes.

The technology represents a novel approach to regenerate insulin producing cells in the body and is currently under development for the treatment of both type I and type II insulin dependent diabetics. The agreement includes an equity investment of C$6m, upfront payments and development milestones potentially totalling US$48m, commercial milestones and royalties.

The INT technology platform, covered by a broad patent portfolio, is based on the discovery that a short course of injections of naturally occurring peptides can regenerate insulin-producing cells in the body. Two lead islet neogenesis products are currently under development. E1-INT, a combination of Transition's epidermal growth factor analogue (E1) and gastrin analogue (G1), has completed two Phase I clinical trials and is advancing towards Phase II clinical trials. GLP1-INT, a combination of one of the leading diabetes drug candidates, Glucagon-Like-Peptide-1 (GLP-1), with G1, is currently in preclinical development.

Under the terms of the licensing agreement, Novo Nordisk will:

Receive exclusive worldwide rights to Transition's INT technology except for INT for transplantation;

Make up-front and milestone payments to Transition which, assuming all development milestones are achieved, will total US$ 48m;

Make an equity investment in Transition of CAN$6m;

Pay commercial milestone payments and royalty payments on future net sales to Transition; and

Assume all costs for the development for the licensed INT technology.

The licensing agreement also provides for Transition to continue advancing programmes that are already in clinical development, specifically E1-INT. Transition intends to move E1-INT into Phase II clinical trials, and will fund development until Novo Nordisk takes over the programme, at its option, at which point Novo Nordisk will retroactively reimburse Transition for costs incurred.

'The signing of this agreement with Novo Nordisk represents a key milestone for Transition and provides significant validation of our work to date,' said Tony Cruz, chairman and ceo of Transition. 'This relationship will allow us to advance key INT programmes while working closely with a world leader in diabetes care.'