After Omeros decided to hit pause on developing its MASP-3 inhibitor zaltenibart, Novo Nordisk has spied an opportunity to scoop up the rare disease drug.
Omeros spent the first weeks of the year readying the necessary trial sites for a phase 3 study of zaltenibart in a rare blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). Now, Novo Nordisk intends to pick up where Omeros dropped off, with the Danish pharma aiming to initiate a global phase 3 program for zaltenibart in PNH as well as “explore further development in a range of other rare blood and kidney disorders.”
This morning’s deal means Omeros could be in line for up to $2.1 billion in total, including $340 million from upfront and near-term milestone payments. The Seattle-based biopharma will also get a slice of the royalties should zaltenibart make it to market, according to the Oct. 15 press release.
The PNH market has been dominated by AstraZeneca’s C5 inhibitors Ultomiris and Soliris, which the pharma acquired as part of its takeover of rare disease company Alexion in 2020. Soliris became the first FDA approved therapy for the condition in 2007, followed in 2018 by Ultomiris, which—like zaltenibart—can be dosed once every eight weeks.
Things had looked promising for zaltenibart by December 2024, when Omeros arrived at the American Society of Hematology annual meeting armed with phase 2 data demonstrating that treatment with zaltenibart resulted in “sustained clinically meaningful improvements in both hemoglobin and absolute reticulocyte count and prevented both intravascular and extravascular hemolysis.”
But in May, the company announced that the “anticipated ramp up in spending” for the planned phase 3 PNH trial, combined with the “need to prioritize the use of currently available capital,” meant that Omeros had “temporarily” hit pause on the program.
The biopharma said at the time that it was “working with our vendors and investigators to ensure that the program is ready to be restarted with as little disruption to the timeline as possible after securing capital.”
Omeros made no secret of the fact that it was hunting for suitable partners across its pipeline, and it seems to have found the right fit in Novo. In this morning’s release, the pharma’s chief scientific officer Martin Holst Lange praised zaltenibart for its “novel mode of action that could offer several advantages over other treatments for complement-mediated diseases.”
“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 a number of rare blood and kidney disorders,” Holst Lange added in the Oct. 15 release.
The acquisition of zaltenibart comes at a time of churn at Novo, as the Wegovy maker lays off thousands of workers and ends work on its cell therapy R&D, while still seeking out fresh opportunities in liver disease and obesity.
This morning’s deal also offers some timely validation of Omeros’ pipeline, coming two months after the FDA pushed back the company’s second attempt to get its anti-MASP-2 antibody narsoplimab approved for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
“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 CEO Gregory Demopulos, M.D., said in the release.
