Emisphere Technologies said today it will develop and commercialize oral formulations of four classes of Novo Nordisk investigational molecules targeting major metabolic disorders—including diabetes and obesity—using Emisphere's oral Eligen® drug-delivery technology. The deal could generate up to $221.5 million-plus for Emisphere.
Emisphere has licensed to Novo Nordisk exclusive rights to develop potential product candidates in three molecule classes, as well as a non-exclusive right to develop potential product candidates in a fourth molecule class via Eligen.
In return, Emisphere will receive from Novo Nordisk a $5 million upfront licensing fee, and is eligible to receive up to $62.5 million in development and sales milestone payments for each of the three exclusively-licensed molecule classes, as well as up to $20 million in development milestone payments for the non-exclusively licensed molecule class. Also, Emisphere would receive royalties on sales of each successfully commercialized product.
Novo Nordisk is solely responsible for the development and commercialization of all product candidates.
Emisphere has also granted Novo Nordisk the option to obtain exclusive and non-exclusive rights to develop and commercialize oral formulations of additional investigational molecules for the treatment of diabetes, obesity, and indications in other important therapeutic areas using Eligen.
Should Novo Nordisk exercise that option, 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 for up to $62.5 million in development and sales milestone payments for each additional exclusively licensed molecule class, and up to $20 million in development milestone payments for each additional non-exclusively licensed molecule class, plus royalties on sales of each commercialized product.
Eligen is designed to deliver a therapeutic molecule without altering its chemical form or biological integrity through the use of synthetic chemical compounds, known as Emisphere delivery agents or carriers.
The companies’ Eligen partnership stretches back to 2008, when Novo Nordisk licensed Eligen to advance its type 2 diabetes program. Two years later, Novo Nordisk licensed the technology to develop oral formulations of its insulin products.
“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,” Emisphere CEO Alan L. Rubino said in a statement.
“We have been intensely focused on transforming Emisphere into a robust commercial and development organization, seeking to identify and establish new, value-creating licensing opportunities for our Eligen Technology to major pharmaceutical companies, while realizing the significant market potential of our proprietary oral Eligen B12™ product,” Rubino added.
Eligen B12, Emisphere’s first prescription drug, is indicated for the dietary management of patients who have a medically-diagnosed vitamin B12 deficiency, associated with a disease or condition that cannot be managed by a modification of the normal diet alone. Eligen B12 was launched in March as the first and only once-daily oral prescription medical food tablet shown to normalize B12 levels without the need for an injection.
“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 also said it agreed with Novo Nordisk to amend their existing GLP-1 (semaglutide) license agreement by adding terms that include a $9 million payment to Emisphere from Novo Nordisk as prepayment of a product development milestone, in exchange for lower future royalty payments.
In August, Emisphere said Novo Nordisk agreed to launch the PIONEER global Phase IIIa development program with oral semaglutide, a once daily tablet formulation of the long-acting GLP-1 analogue semaglutide for type 2 diabetes. PIONEER consists of seven trials and approximately 8,000 patients with type 2 diabetes.