PRX004 is a phase 2ready anti-amyloid immunotherapy designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis.
ATTR amyloidosis is a rare, progressive and fatal disease characterised by the abnormal build-up of amyloid deposits composed of misfolded transthyretin protein in organs and tissues, most commonly the heart and/or nervous system.
Prothena has completed a phase 1 study with PRX004 in patients with hereditary forms of ATTR, in which PRX004 was found to be safe and well tolerated.
Novo Nordisk will initially focus on the clinical development of PRX004 in ATTR cardiomyopathy - an underdiagnosed and potentially fatal form of ATTR amyloidosis characterised by build-up of amyloid deposits in cardiac tissue.
Under the terms of the definitive purchase agreement, Novo Nordisk acquires Prothena’s wholly-owned subsidiary and gains full worldwide rights to the intellectual property and related rights of Prothena’s ATTR amyloidosis business and pipeline. Prothena is eligible to receive development and sales milestone payments totalling up to 1.2 billion US dollars including 100 million dollars in upfront and near-term clinical milestone payments.
“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,” said Hideki Garren, MD, PhD, chief medical officer of Prothena. “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. We also wish to extend our sincere thanks and appreciation to all the patients and investigators who participated in the PRX004 phase 1 study.”
“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,” said Marcus Schindler, chief scientific officer, EVP Research and Early Development at Novo Nordisk. “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.”