Palopegteriparatide

The Danish companies aim to jointly develop a GLP-1RA administered once a month. Credit: Kittyfly / Shutterstock Novo Nordisk and Ascendis Pharma have agreed to collaborate in developing metabolic and cardiovascular therapies, among them a once-monthly glucagon-like peptide receptor agonist (GLP-1RA). The collaboration will focus on Novo Nordisk’s obesity and type 2 diabetes products, chief among them a once-monthly GLP-1RA to be developed as the joint venture’s lead candidate. Under the deal’s terms, Novo Nordisk holds exclusive rights to expand resulting metabolic disease products into other therapeutic areas. Novo Nordisk is known globally for its GLP-1RA drug semaglutide, marketed as Wegovy for obesity and Ozempic for type 2 diabetes. The drug is predicted to make $42.85bn in sales in 2030, according to GlobalData. Novo Nordisk’s biggest rival is Eli Lilly’s candidate tirzepatide, marketed as Mounjaro for T2D and Zepbound for obesity, which is predicted to bring in $57.65bn in the same year. A once-monthly drug would be attractive to patients compared to the once-weekly dosing with current alternatives. GlobalData is the parent company of Pharmaceutical Technology. As per the deal signed yesterday (4 November), the two Danish companies will jointly develop therapeutics for metabolic and cardiovascular indications. Ascendis will grant an exclusive, worldwide license for its TransCon technology to Novo Nordisk to develop, manufacture, and commercialise metabolic disease products and product-by-product licenses for those in cardiovascular indications. In return, Ascendis will be eligible to receive total upfront payments from Novo Nordisk of up to $285m, with up to $77.5m in developmental and regulatory milestone payments for each asset concerned as well as sales-based milestone payments and tiered royalties on net sales. Finalisation of the deal depends on regulatory approvals, which both parties seek to achieve by the end of 2024. The TransCon platform allows the transient conjugation of an inert carrier to a parent drug for systemic or local release of a therapeutic payload. Ascendis gained US Food and Drug Administration (FDA) approval for its TransCon-based hypoparathyroidism drug Yorpvipath (palopegteriparatide) in August 2024. In October, the company submitted a supplemental biologics licence application (sBLA) for TransCon hGH, marketed as Skytrofa, to treat growth hormone deficiency. Ascendis stock saw a slight uptick following the disclosure of the deal, rising in value by 1.5% as markets opened on 4 November, adding to the company’s market cap of $7.5bn. According to GlobalData, Ascendis is projected to bring in $508m in global revenue in 2024, set to increase to an annual $4.2bn by 2030. Jan Mikkelesen, Ascendis CEO, said, “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.” This deal adds to a collaboration made in 2023 with Teijin Limited, licensing TransCon technology for endocrinological rare diseases, as well as the company’s creation of Eyconis to apply TransCon in ophthalmological indications. Senior Vice President of global research technologies at Novo Nordisk, Brian Vandahl, emphasised the company’s interest in reducing the frequency of therapy delivery and underscored the potential of using the TransCon platform to achieve this.

Dive Brief:Novo Nordisk is investing further in obesity and metabolic disease, signing a deal to use Ascendis Pharmas delivery technology to advance a long-acting GLP-1 drug as well as develop products in diabetes and cardiovascular conditions, Ascendis said Monday.Per deal terms, Novo could pay up to $285 million in immediate and milestone-based fees to Ascendis for the GLP-1 drug, depending on its progress toward approval. In addition, Ascendis could receive up to $77.5 million for each additional drug developed.Ascendis has won Food and Drug Administration approval of two products using its extended release technology, both in rare conditions. In partnering with Novo, Ascendis would gain entry into conditions that have blockbuster sales potential.Dive Insight:Ascendis claims its drug delivery technology can be tailored to reduce dosing frequency or deliver a therapeutic molecule directly to tissue with disease activity. Its two approved products, Skytrofa for growth hormone deficiency and Yorvipath for hypoparathyroidism, are weekly and daily shots, respectively.In obesity and diabetes, the leading GLP-1 drugs, which include Novos Wegovy and Ozempic, require injections once a week. Novo believes longer-acting agents could help patients stay on their medications. Research released in July showed that more than half of those who initiate GLP-1 treatment discontinue use in just six months.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, said Brian Vandahl, senior vice president of global research technologies at Novo Nordisk, in a statement.The lead product under the collaboration, which grants Novo an exclusive worldwide license to Ascendis technology, is a once-monthly GLP-1 drug.Ascendis will conduct early development of the drugs developed under the collaboration, with Novo financing that stage of research and assuming clinical, regulatory and commercial development of the drugs.The fees from this collaboration will add to several cash infusions Copenhagen-based Ascendis has received to help fund its operations. In September, Ascendis sold 3% of Yorvipath royalties to Royalty Pharma for $150 million and, later in the same month, sold $281 million in shares following approval of Yorvipath.Despite having two approved products, only one is fully launched. Ascendis lost 240 million euros, or about $262 million, in the first six months of the year. It held 259 million euros in cash as of June 30. '