Novo to Acquire Omeros’s Experimental Therapy for Rare Blood and Kidney Diseases

Rare Daily Staff

Novo Nordisk entered into a definitive asset purchase and license agreement with Omeros for its experimental rare kidney and blood disease therapy, zaltenibart, for $340 million in upfront and near-term milestone payments.

Under the terms of the agreement, Omeros is eligible to receive up to $2.1 billion, including potential development and commercial milestones, plus tiered royalties on net sales.

The deal will enhance Novo Nordisk’s rare disease portfolio.

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, a crucial part of the immune system, is involved in the pathophysiology of several rare diseases.

Omeros retains certain rights to its preclinical MASP-3 programs unrelated to zaltenibart, including the ability to develop and commercialize small-molecule MASP-3 inhibitors with limited indication restrictions.

Omeros has reported positive Phase 2 data for zaltenibart in paroxysmal nocturnal hemoglobinuria, a rare, acquired blood disorder in which the body’s 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. It has been well tolerated and has demonstrated an acceptable safety profile across all clinical trials to date.

Following the closing of the transaction, Novo Nordisk aims to initiate a global Phase 3 program for zaltenibart in PNH and explore further development in a range of other rare blood and kidney disorders.

“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 and development at Novo Nordisk. “Novo Nordisk is in a strong position to build on the work done by Omeros to maximize the value of this asset and develop zaltenibart into a differentiated and potentially best-in-class treatment approach for a number of rare blood and kidney disorders.”