Novo Nordisk Pledges $285M to Ascendis for Long-Acting GLP-1 Drug Collaboration

Novo Nordisk, a frontrunner in the development of GLP-1 drugs for metabolic disorders, is advancing its drug delivery methods from once-weekly injections to potentially once-monthly doses. The Danish pharmaceutical company has committed $285 million to establish a strategic alliance with Ascendis Pharma, also based in Denmark. This partnership aims to leverage Ascendis Pharma's TransCon technology to develop drugs that require less frequent dosing.

The collaboration's primary focus is on creating a once-monthly GLP-1 drug for metabolic diseases. However, the agreement also extends to cardiovascular conditions. Ascendis Pharma will handle the early development phases of the product candidates using its TransCon platform, while Novo Nordisk will shoulder the expenses for early development and clinical trials. Additionally, Novo Nordisk will manage regulatory affairs, commercial manufacturing, and the marketing of any products resulting from the partnership.

TransCon is a unique technology platform designed to prolong a drug's activity in the body, thereby reducing the frequency of dosing. Ascendis Pharma's TransCon technology has already achieved clinical and regulatory success. The FDA has approved two Ascendis products: Skytrofa and Yorvipath. Skytrofa, approved in 2021, is a once-weekly injectable treatment for pediatric growth hormone deficiency, offering an alternative to daily injections. Yorvipath, approved in August, is a once-daily injectable for hypoparathyroidism, replacing a more cumbersome treatment that necessitates multiple daily injections.

The agreement provides Novo Nordisk with an exclusive global license to use Ascendis's technology for the development of its drugs in metabolic diseases. For cardiovascular disease drugs, the license is granted on a product-by-product basis. According to a regulatory filing, the primary goal of the partnership is to develop a once-monthly version of semaglutide. Semaglutide is the main ingredient in Novo Nordisk's GLP-1 products, Ozempic and Wegovy, which are used for treating type 2 diabetes and obesity, respectively. The license allows Novo Nordisk to utilize TransCon to develop and commercialize GLP-1 drugs for various indications, excluding specific rare endocrine conditions, eye-related issues, and cancer. These exclusions ensure that the collaboration does not encroach on areas where Ascendis Pharma already has product candidates in its pipeline. However, Novo Nordisk retains the exclusive right to expand any resultant metabolic disease products into other therapeutic areas.

The financial commitment from Novo Nordisk includes an upfront payment of $100 million to Ascendis Pharma for the exclusive license. The remaining funds are earmarked for development and regulatory milestone payments for the lead program. Additionally, Ascendis Pharma could earn up to $77.5 million for each additional metabolic or cardiovascular disease drug candidate developed under the alliance. The company is also eligible for milestone payments and royalties based on the sales of any approved products resulting from the collaboration. Novo Nordisk and Ascendis Pharma anticipate finalizing the deal by the end of this year.

Brian Vandahl, Novo Nordisk's senior vice president of global research technologies, expressed optimism about the partnership. "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," Vandahl stated. "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."