Novo Nordisk intends to initially develop the Phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy


Novo Nordisk to acquire Prothena’s ATTR amyloidosis assets. (Credit: Adam Radosavljevic from Pixabay.)

Novo Nordisk has reached a definitive agreement with Irish biotechnology firm Prothena to acquire the latter’s ATTR amyloidosis business, including its lead candidate PRX004.

Under the terms of the agreement, Novo Nordisk will acquire Prothena’s wholly-owned subsidiary to obtain full rights to Prothena’s ATTR amyloidosis business.

Prothena will receive a total of up to $1.2bn in development and sales milestone payments, including an upfront near-term clinical milestone payment of $100m.

Novo Nordisk intends to initially focus on the clinical development of PRX004 in ATTR cardiomyopathy, which is often underdiagnosed.

Novo Nordisk research and early development EVP, chief scientific officer Marcus Schindler said: “With its innovative amyloid-depleting mechanism, PRX004 has the potential to offer a novel treatment option for ATTR cardiomyopathy, an often fatal disease with significant unmet medical need.

“This acquisition is a testament to Prothena’s pioneering work in ATTR amyloidosis and Novo Nordisk’s dedication to advancing new disease-modifying therapies for the benefit of people with cardiovascular diseases which are the world’s leading cause of death.”

PRX004 is a Phase 2ready investigational humanised monoclonal antibody designed to diminish the amyloid deposits related to the disease pathology of ATTR amyloidosis.

In the preclinical studies, the therapy was found to help the depletion of insoluble amyloid fibrils through antibody-mediated phagocytosis and inhibit amyloid formation.

ATTR amyloidosis is a rare, progressive and mortal disease that involves the abnormal build-up of amyloid deposits in organs and tissues, and prevalently in the heart and nervous system.

Prothena has completed a Phase one, open-label, multicentre dose-escalation study of PRX004 in patients with hereditary forms of ATTR.

The study enrolled 21 patients to receive PRX004 intravenously once every 28 days for up to 3 infusions and showed that PRX004 is safe and well-tolerated.

Prothena chief medical officer Hideki Garren said: “Today’s announcement is consistent with our commitment to create a better future for patients in critical need of new treatment options.

“We are confident that Novo Nordisk will leverage its extensive expertise in developing treatments for those affected by cardiovascular diseases to advance this promising potential treatment to patients on an expedited timeline.

“With Novo Nordisk’s commitment to further develop PRX004 in ATTR cardiomyopathy, Prothena will continue to focus on our mission to advance our robust portfolio designed to address rare peripheral amyloid and neurodegenerative diseases.”

Last year, Novo Nordisk agreed to acquire US-based Corvidia Therapeutics for around $2.1bn.