Roche and Prothena, a clinical-stage biopharmaceutical company, have formed a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody (mAb) for the treatment of Parkinson's disease, which is currently in preclinical development and is expected to enter Phase I clinical trials in patients with Parkinson's disease in 2014.
Synuclein proteins are a family of charged proteins found throughout the body. One protein from this family, alpha-synuclein, is found extensively in neurons and is a major component of pathological inclusions that characterize several neurodegenerative disorders, including Parkinson's disease, dementia with Lewy bodies, neurodegeneration with brain iron accumulation Type 1, and multiple system atrophy, which collectively are termed synucleinopathies.
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 United States. In the US, 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 US, Roche will have sole responsibility for developing and commercializing PRX002 and will pay Prothena up to double-digit royalties on net sales.
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-US commercial milestone payments. The total worldwide upfront and milestone payments may amount up to $600 million.
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. The transaction is subject to customary regulatory clearances, including expiration of the applicable Hart- Scott-Rodino waiting period.