Novo Nordisk and Omeros Corporation have announced that they have entered into a definitive asset purchase and license agreement for the candidate drug zaltenibart in clinical development for rare blood and kidney disorders.
Under the terms of the agreement, Novo Nordisk will be granted exclusive global rights to develop and commercialise zaltenibart in all indications.
Omeros is eligible to receive $340m in upfront and near-term milestone payments, up to a total of $2.1bn, including potential development and commercial milestones plus tiered royalties on net sales.
Zaltenibart is an antibody designed to inhibit MASP-3, a protein that acts as a key activator of the complement system’s alternative pathway.
Dysregulation of the complement system, which is a crucial part of the immune system, has been shown to be involved in the pathophysiology of a number of rare diseases.
“Zaltenibart has a novel mode of action that could offer several 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.
“Novo Nordisk is in a strong position to build on the work done by Omeros to maximise the value of this asset and develop zaltenibart into a differentiated and potentially best-in-class treatment approach for several rare blood and kidney disorders.”
Omeros has reported positive Phase II data for zaltenibart in paroxysmal nocturnal haemoglobinuria (PNH).
PNH is a rare, acquired blood disorder where the immune system mistakenly attacks and destroys red blood cells, leading to low levels of healthy red blood cells and other complications.
Zaltenibart has shown multiple potential advantages over other alternative pathway inhibitors in development or on the market and has demonstrated an acceptable safety profile across all clinical trials to date.
“We are pleased to enter into this agreement with Novo Nordisk, a global leader in therapeutic innovation and development,” said Gregory Demopulos, Chairman and CEO of Omeros.
“We look forward to Novo Nordisk leveraging its extensive expertise and global reach to unlock the potential of zaltenibart across alternative pathway indications."
"With Novo Nordisk driving the success of zaltenibart, Omeros remains focused on securing approval and commercialisation of narsoplimab this quarter and continuing to advance its robust development pipeline.”
Omeros retains certain rights to its preclinical MASP-3 programmes unrelated to zaltenibart, including the ability to develop and commercialise small-molecule MASP-3 inhibitors with limited indication restrictions.
Following the closing of the transaction, Novo Nordisk aims to initiate a global Phase III programme for zaltenibart in PNH and explore further development in a range of other rare blood and kidney disorders.
“With zaltenibart, we have a compelling opportunity to help a significant number of people living with rare blood and kidney disorders in the future and support our leadership ambition in this space,” said Ludovic Helfgott, Executive Vice President of Product and Portfolio Strategy at Novo Nordisk.
“This agreement will build on Novo Nordisk’s heritage and enhance our existing Rare Disease portfolio with potential to drive additional growth in this business area.”
The transaction is subject to certain customary closing conditions, including applicable regulatory approvals and is expected to close in the fourth quarter of 2025.