PharmaShots Interview: Prothena's Brandon Smith Shares Insight on the Acquisition of Prothena and Novo Nordisk

In an interview with PharmaShots, Brandon Smith, Chief Business Officer at Prothena shared his views on Novo Nordisk's acquisition of Prothena's ATTR amyloidosis program includes PRX004

Shots:

The companies have entered into a definitive purchase agreement in which Novo Nordisk has acquired Prothena's PRX004 and broader ATTR amyloidosis program
Novo Nordisk acquires Prothena's subsidiary and gets WW rights to the IP and related rights of Prothena's ATTR amyloidosis business and pipeline. Novo Nordisk will initially focus on the clinical development of PRX004 in ATTR cardiomyopathy
Prothena has completed a P-I study of PRX004 in patients with hereditary forms of ATTR which showed that the therapy was safe and well-tolerated

Tuba: Discuss the deal terms in detail of the acquisition of Prothena's ATTR amyloidosis program.

Brandon Smith: Prothena and Novo Nordisk have entered into a definitive purchase agreement under which Novo Nordisk has acquired Prothena's clinical-stage antibody PRX004 and broader ATTR amyloidosis program.

Tuba: What will be the impact of the acquisition on Prothena's business and vision?

Brandon Smith: This acquisition will allow Prothena to continue to focus on its mission to advance a robust portfolio designed to address rare peripheral amyloid and neurodegenerative diseases. Under the terms of the 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. Prothena is eligible to receive development and sales milestone payments totaling up to 1.23 billion US dollars including 100 million dollars in upfront and near-term clinical milestone payments.

Tuba: What does this acquisition mean for Prothena?

Brandon Smith: This acquisition will allow Prothena to continue to focus on its mission to advance a robust portfolio designed to address rare peripheral amyloid and neurodegenerative diseases.

Our vision is bold : to offer truly transformational disease-modifying treatments designed with the patient in mind, and to eradicate Alzheimer's disease. In doing so, we want to eliminate the suffering experienced by patients, the staggering burden on caregivers, and the economic cost to society associated with one of the most overwhelming and debilitating diseases.

Tuba: What is PRX004? Discuss the potential of the therapy in ATTR cardiomyopathy.

Brandon Smith: PRX004 is a phase 2 ready anti-amyloid immunotherapy uniquely designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis. As part of the acquisition, Novo Nordisk will initially focus on the clinical development of PRX004 in ATTR cardiomyopathy an underdiagnosed and potentially fatal form of ATTR amyloidosis characterized by the build-up of amyloid deposits in cardiac tissue.

Tuba: Are you looking for a similar kind of purchase agreement for your other programs?

Brandon Smith: We are committed to developing novel and transformative medicines and treatments to create a better future for people in critical need of new treatment options and we know that this need is greater than ever. This transaction allows us to deploy additional resources to focus on the execution of the AFFIRM-AL trial, a confirmatory study of birtamimab in Stage IV AL amyloidosis patients and to advance our robust Alzheimer's portfolio. We remain focused on our path forward and this is what fuels our mission every day.

Tuba: Discuss the P-I results of PRX004 supporting the potential of the therapy in ATTR patients.

Brandon Smith: Prothena completed a Phase 1, open-label, multicenter dose-escalation study (NCT03336580). In the first report of clinical results with this depleter mechanism of action, PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months, including improvement in neuropathy in 3 of the 7 patients, and improved cardiac systolic function for all 7 patients. In this Phase 1 study, PRX004 was found to be generally safe and well-tolerated across all dose levels. PRX004 was found to be safe and well-tolerated across all dose levels.

Furthermore, PRX004 has been shown in preclinical studies to promote the clearance of insoluble amyloid fibrils through antibody-mediated phagocytosis and inhibit amyloid formation. This depleter mechanism of action has the potential to provide benefit for ATTR patients at high risk for early mortality due to amyloid deposition in vital organs.

Tuba: Give a glance at Prothena's robust pipeline.

Brandon Smith: Prothena is integrating scientific insights and extensive experience around protein dysregulation to advance a pipeline of therapeutic candidates for several rare peripheral amyloid and neurodegenerative diseases. Our wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis and a portfolio of programs for the potential treatment of Alzheimer's disease. This includes our next-generation anti-Aß antibody PRX012 and dual Aß-tau vaccine being developed for the prevention and treatment of Alzheimer's disease. Our partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson's disease, and programs that target tau (PRX005), TDP-43, and an undisclosed target in collaboration with Bristol Myers Squibb for the potential treatment of neurodegenerative diseases.

Tuba: Tell us about Prothena Corporation. What's next, we can expect in the company's pipeline?

Brandon Smith: Prothena is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases.

At this year's Alzheimer's Association International Conference 2021, we presented new preclinical data from two of our Alzheimer's programs, including PRX012, our next-generation anti-Aß antibody being developed for subcutaneous administration for patients with Alzheimer's disease, as well as data on our dual Aß-tau vaccine program being developed for the prevention and treatment of the devastating disease.

Prothena is undergoing a transformational moment with notable milestones over the next 12 months. For birtamimab, VITAL study 9-month results are expected to be presented at a medical conference in 2021, results from Part 2 of the PASADENA study for prasinezumab are expected to be presented at an upcoming medical conference, and we expect to submit our IND application for PRX012 in 1Q 2022. Additionally, we expect to receive more than $150 million in milestone payments next year through agreements with Novo Nordisk and Bristol Myers Squibb.

The AAIC presentation announcements, as well as our forthcoming milestones, are further testament to our commitment to leverage our protein dysregulation expertise to fuel a diverse range of new treatments and medicines that are designed to offer enhanced efficacy, safety, and access for patients suffering from rare peripheral amyloid and neurodegenerative diseases.

Source: Norton Children's

About Author: Brandon Smith is the Chief Business Officer of Prothena. Mr. Smith earned his B.S. in Chemical Engineering at the University of Michigan and his M.B.A from The University of Texas at Austin McCombs Graduate School of Business