Novo Nordisk and Omeros Corporation announced that they have entered into a definitive asset purchase and license agreement for Omeros’ clinical-stage MASP-3 inhibitor, zaltenibart, currently in development for rare blood and kidney disorders. 

Under the terms of the agreement, Novo Nordisk will receive exclusive global rights to develop and commercialise zaltenibart across all indications. Omeros is eligible to receive US4 340 million in upfront and near-term milestone payments, and up to US$ 2.1 billion in total, including potential development and commercial milestones, as well as tiered royalties on future net sales. 

Zaltenibart is a monoclonal antibody designed to inhibit MASP-3, a key activator of the complement system’s alternative pathway. Dysregulation of this pathway plays a significant role in the pathophysiology of various rare complement-mediated diseases. 

“Zaltenibart has a novel mode of action that could offer distinct advantages over other treatments for complement-mediated diseases,” said Martin Holst Lange, Chief Scientific Officer and Executive Vice President of Research & Development at Novo Nordisk. “We are well positioned to build on Omeros’ work and advance zaltenibart as a potentially best-in-class therapy for a range of rare blood and kidney disorders.”

 Omeros has reported positive Phase 2 results for zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH), a rare acquired blood disorder in which the immune system destroys red blood cells, leading to anemia and other complications. 

“We are pleased to enter into this agreement with Novo Nordisk, a global leader in therapeutic innovation,” said Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros. “Novo Nordisk’s expertise and global reach will help fully realise zaltenibart’s potential across alternative pathway disorders. With Novo Nordisk advancing this program, Omeros will remain focused on the upcoming approval and commercialisation of narsoplimab and the continued progress of our broader pipeline.” 

Omeros will retain certain rights to its preclinical MASP-3 programmes unrelated to zaltenibart, including the development and commercialisation of small-molecule MASP-3 inhibitors for select indications. 

Following completion of the transaction, Novo Nordisk plans to initiate a global Phase 3 programme for zaltenibart in PNH and explore further development across other rare blood and kidney diseases. 

“Zaltenibart presents a compelling opportunity to improve outcomes for people living with rare blood and kidney disorders while strengthening Novo Nordisk’s leadership in the Rare Disease space,” said Ludovic Helfgott, Executive Vice President of Product and Portfolio Strategy at Novo Nordisk. “This agreement builds on our heritage and enhances our portfolio with a promising growth driver in this important therapeutic area.”