Novo Nordisk was a pioneer in developing GLP-1 drugs for metabolic disorders, but its products are still mainly once-weekly injections. The Danish pharmaceutical giant is putting up $285 million to begin a strategic alliance granting the pharmaceutical giant access to Ascendis Pharma technology that could develop its drugs for dosing every four weeks. The lead product candidate for the partnership is a once-monthly GLP-1 drug for metabolic indications, but the agreement also includes cardiovascular diseases.
Under deal terms announced Monday, Ascendis, which is also based in Denmark, will conduct early development of the product candidates using its TransCon technology. Novo Nordisk will cover the costs of early development and clinical testing. It's also responsible for regulatory, commercial manufacturing, and commercialization of products stemming from the partnership.
TransCon is a platform technology that extends the duration of a drug's activity in the body, which in turn permits less frequent dosing. The technology already has clinical and regulatory validation through two FDA-approved Ascendis products. Skytrofa, a drug for pediatric growth hormone deficiency, won its FDA nod in 2021. That once-weekly injectable medication was developed as an alternative to daily growth hormone injections. In August, the FDA approved Ascendis's once-daily injectable Yorvipath as treatment for hypoparathyroidism. Yorvipath provides an alternative to an engineered version of parathyroid hormone that requires multiple injections per day.
The new agreement grants Novo Nordisk an exclusive worldwide license to Ascendis's technology to develop the pharma giant's drugs in metabolic diseases. The license for cardiovascular disease drugs is on a product-by-product basis. In a regulatory filing, Ascendis said the collaboration's lead program aims to develop once-monthly semaglutide, the main pharmaceutical ingredient in the Novo Nordisk GLP-1 products Ozempic, for type 2 diabetes, and Wegovy, for obesity. The license permits Novo Nordisk to use TransCon to develop and commercialize GLP-1 drugs for all indications except for certain rare endocrine indications, indications of the eye and the region around the eye, and cancer. Those exclusions keep the alliance from spreading into areas where Ascendis's internal pipeline already has product candidates. But Novo Nordisk has exclusive rights to expand any resulting metabolic disease products into other therapeutic areas.
Per the regulatory filing, the $285 million sum includes $100 million up front to Ascendis for the exclusive license. The balance is for development and regulatory milestone payments for the lead program. For each additional metabolic or cardiovascular disease drug candidate developed under the alliance, Ascendis could earn up to $77.5 million in development and regulatory milestone payments. It is also eligible for milestone payments and royalties tied to sales of each approved product produced by the collaboration. Novo Nordisk and Ascendis expect to close the deal by the end of this year.
"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," Brian Vandahl, Novo Nordisk senior vice president of global research technologies, said in a prepared statement. "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."