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  1. Emisphere Technologies
23 October 2015

Emisphere Signs License Agreement with Novo Nordisk to Develop Oral Formulations of Four Molecules Targeting Metabolic Indications

Emisphere Technologies has announced it has entered a development and license agreement with Novo Nordisk to develop and commercialise oral formulations of four classes of Novo Nordisk’s investigational molecules targeting major metabolic disorders, including diabetes and obesity, using Emisphere’s oral Eligen technology.

Under the agreement, Emisphere licensed to Novo Nordisk the exclusive right to develop potential product candidates in three molecule classes.

The company also licensed to Novo Nordisk the non-exclusive right to develop potential product candidates in a fourth molecule class using Eligen’s technology.

The license provides Emisphere with a $5m upfront licensing fee, and the opportunity to receive up to $62.5m in development and sales milestone payments for each of the three exclusively licensed molecule classes, and up to $20m in development milestone payments for the non-exclusively licensed molecule class.

In addition, Emisphere would receive royalties on sales of each successfully commercialised product. Novo Nordisk is solely responsible for the development and commercialisation of all product candidates.

Emisphere also granted Novo Nordisk the option to obtain exclusive and non-exclusive rights to develop and commercialise oral formulations of additional investigational molecules for the treatment of diabetes, obesity, and indications in other important therapeutic areas using the Eligen technology.

If Novo Nordisk exercises its option to develop and commercialise any additional investigational molecules, Emisphere would be entitled to receive an additional payment upon the exercise of each option for exclusive or non-exclusive development rights for each molecule class.

Emisphere would be eligible to receive up to $62.5m in development and sales milestone payments for each additional exclusively licensed molecule class, and up to $20m in development milestone payments for each additional non-exclusively licensed molecule class, plus royalties on sales of each commercialized product.

Emisphere and Novo Nordisk also amended their existing GLP-1 (semaglutide) license agreement to provide a payment of $9m to Emisphere from Novo Nordisk as prepayment of a product development milestone in exchange for a reduction in future royalty payments.

Novo Nordisk Global Research senior vice-president Peter Kurtzhals said: "We are delighted to have broadened our collaboration with Emisphere for access to their Eligen technology under this new development and license agreement."

Emisphere CEO Alan L Rubino said: "Novo Nordisk has been an important partner for many years and this expanded partnership further validates the Eligen technology and its ability to facilitate absorption from the gastrointestinal tract.

"We have been intensely focused on transforming Emisphere into a robust commercial and development organisation, seeking to identify and establish new, value-creating licensing opportunities for our Eligen technology to major pharmaceutical companies, while realising the significant market potential of our proprietary oral Eligen B12 product.

"This agreement with Novo Nordisk represents the first significant accomplishment in this ongoing, transformational effort and we look forward to future successes resulting from our global business development strategy."

Emisphere's Eligen® Technology binds a delivery agent with a therapeutic compound without alternation. This process occurs when both agent and compound are in close proximity.
Originally published by Elsevier Journals on 24 May 2011, this white paper outlines an open-label, randomised, single-dose, parallel-group study of the pharmacokinetics of oral cyanocobalamin...
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