Date: 2013-12-12
Type of information: R&D agreement
Compound: antibodies that target alpha-synuclein, including PRX002
Company: Roche (Switzerland) Prothena (Ireland)
Therapeutic area: Neurodegenerative diseases
Type agreement: R&D
development
commercialisation
Action mechanism: PRX002, a monoclonal antibody targeting alpha-synuclein, has been tested in various cellular and animal models of synuclein-related disease and has shown in multiple transgenic mouse models of Parkinson\'s disease, that passive immunization with 9E4, the murine version of PRX002, reduced the appearance of synuclein pathology, protected synaptic connections and improved performance by the mice in behavioral testing. PRX002 may slow or reduce the neurodegeneration associated with synuclein misfolding and/or cell-to-cell transmission of pathogenic forms of synuclein.
Disease: Parkinson\'s disease
Details: * On December 12, 2013, Roche and Prothena Corporation have announced that they have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena\'s monoclonal antibody for the treatment of Parkinson\'s disease, which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson\'s disease in 2014.
Roche and Prothena will collaborate on the development of PRX002 for Parkinson\'s disease and potentially other synucleinopathies. Prothena also has an option to co-promote PRX002 in the U.S. In the U.S., the companies will share all development and commercialization costs, as well as profits, on a 70/30 basis (70% Roche and 30% Prothena). Outside the U.S., Roche will have sole responsibility for developing and commercializing PRX002 and will pay Prothena up to double-digit royalties on net sales. Also as part of the agreement, Roche and Prothena will initiate a research collaboration focused on optimizing early stage antibodies targeting alpha-synuclein including incorporation of Roche\'s proprietary Brain Shuttle™ technology to increase delivery of therapeutic antibodies to the brain.
Financial terms: Under the terms of the agreement, Prothena will receive an upfront payment and near-term clinical milestone totaling $45 million. Prothena is also eligible to receive additional payments of up to $380 million upon the achievement of development, regulatory and first commercial sales milestones plus up to an additional $175 million in ex-U.S. commercial milestone payments. The total worldwide upfront and milestone payments may amount up to $600 million.
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