AstraZeneca Expands Amyloidosis Portfolio with $780M Neurimmune Deal

AstraZeneca has significantly bolstered its presence in the amyloidosis treatment landscape, announcing a new licensing agreement with Swiss biotech firm Neurimmune. The deal, which could reach $780 million, centers on NI009, a preclinical monoclonal antibody targeting light chain (AL) amyloidosis.

Deal Structure and Asset Details

The agreement grants AstraZeneca's rare disease unit, Alexion Pharmaceuticals, exclusive rights to NI009. The financial terms include an undisclosed upfront payment and potential development, regulatory, and commercial milestone payments totaling up to $780 million. Neurimmune is also set to receive tiered royalties on net sales if NI009 reaches the market.

NI009 is described as being in "advanced preclinical development" and targets lambda light chain fibrils and deposits in affected tissues and organs of AL amyloidosis patients. Neurimmune's CEO, Roger Nitsch, highlighted the drug's "broad activity against amyloids of diverse lambda light chain subtypes across patients despite the high clonal heterogeneity of the disease."

Strategic Expansion in Amyloidosis

This latest collaboration builds upon AstraZeneca's existing partnership with Neurimmune in the amyloidosis space. In early 2022, AstraZeneca paid $30 million to license NI006, an ATTR amyloidosis candidate. Recent phase 1 data for NI006 showed "substantial" reductions in cardiac amyloid deposition at higher doses, according to Neurimmune.

The expansion into lambda light chain amyloidosis complements AstraZeneca's existing work with anselamimab, an AL amyloidosis candidate acquired through the purchase of Caelum Biosciences in 2021. Despite recent setbacks in a phase 3 trial where anselamimab failed to reduce deaths and hospitalizations, AstraZeneca remains optimistic about its potential in specific patient subgroups.

Clinical Development and Future Prospects

Neurimmune will oversee the first clinical trial of NI009 before transferring development responsibilities to Alexion. Gianluca Pirozzi, head of development, regulatory and safety at Alexion, expressed enthusiasm about applying learnings from the anselamimab CARES program to the development of NI009, aiming to "potentially benefit more patients living with AL amyloidosis."

The collaboration underscores AstraZeneca's commitment to addressing rare diseases, particularly in the complex field of amyloidosis. As the company continues to invest in novel therapies, the pharmaceutical industry watches closely to see how these strategic moves will shape the future of amyloidosis treatment.