Ascendis Pharma A/S announced that it has granted Novo Nordisk A/S an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases. The agreement includes provisions requiring certain TransCon technology-based products to be identified and advanced in metabolic diseases to maintain exclusivity in the field and additional provisions for cardiovascular diseases. Under the terms of the agreement, Novo Nordisk also receives exclusive rights to expand any resulting metabolic disease products into other therapeutic areas. The lead program in the collaboration is a once-monthly GLP-1 receptor agonist product candidate that will initially target obesity and type 2 diabetes.
In exchange for the license, Ascendis will be eligible to receive total payments of up to $285 million in upfront, development, and regulatory milestone payments for the lead program. In addition, Ascendis will be eligible to receive sales-based milestone payments and tiered royalties on global net sales. For each additional metabolic or cardiovascular disease product candidate, Ascendis will be eligible to receive payments of up to $77.5 million in development and regulatory milestone payments, plus sales-based milestone payments and tiered royalties on global net sales.
Ascendis will conduct early development of TransCon product candidates under the collaboration. Novo Nordisk will be responsible for these early development costs and for clinical development, regulatory, commercial manufacturing, and commercialization.
“We are pleased to collaborate with Novo Nordisk, an established expert in metabolic diseases, to maximize the potential of TransCon products for helping patients,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “The agreement with Novo Nordisk reflects our Vision 2030 to create value in additional large therapeutic areas outside endocrinology rare disease through collaborations with established global leaders.”
“Developing potential therapies that can be administered less frequently could benefit societies as well as individual patients, and it is a clear focus area for Novo Nordisk,” said Brian Vandahl, Senior Vice President of Global Research Technologies at Novo Nordisk. “We look forward to working with Ascendis to explore the potential of the TransCon technology platform to reduce the dosing frequency of GLP-1 receptor agonists and other treatments for cardiometabolic diseases.”
The closing of this transaction is subject to receipt of applicable regulatory approvals and the parties are seeking to close before the end of 2024.