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December 11, 2013

Roche and Prothena to jointly develop and promote antibodies for Parkinson’s treatment

Roche and Prothena have entered into a collaboration to develop and commercialise antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody for the treatment of Parkinson's disease (PD).

Park protein

Roche and Prothena have entered into a collaboration to develop and commercialise antibodies that target alpha-synuclein, including PRX002, Prothena’s monoclonal antibody for the treatment of Parkinson’s disease (PD).

Under the deal, both the firms will jointly develop PRX002 for Parkinson’s disease and potentially other synucleinopathies.

In the US, Prothena also has an option to co-promote PRX002, while the development, commercialisation costs and profits will be shared on a 70/30 basis by Roche and Prothena respectively.

Roche will have sole responsibility for developing and commercialising PRX002 outside the US and it will pay Prothena up to double-digit royalties on net sales.

The deal will see Prothena receive an upfront payment and near-term clinical milestone totalling $45m.

Prothena is also eligible to receive additional payments of about $380m upon the achievement of development, regulatory and first commercial sales milestones, as well as up to an additional $175m in ex-US commercial milestone payments.

According to the firms, the total worldwide upfront and milestone payments may amount up to $600m.

Under the deal, the firms will also start a research collaboration focused on optimising early stage antibodies targeting alpha-synuclein including incorporation of Roche’s proprietary Brain Shuttle technology to increase delivery of therapeutic antibodies to the brain.

Roche neuroscience and small molecules research Luca Santarelli said Parkinson’s is a severely debilitating and progressive neurodegenerative disease that leads to both a gradual worsening of motor function and cognitive and behavioral alterations.

"Currently, there is no treatment that modifies its course, and by targeting one of Parkinson’s key molecular determinants, PRX002 has the potential to slowdown or reduce its progression."

"Currently, there is no treatment that modifies its course, and by targeting one of Parkinson’s key molecular determinants, PRX002 has the potential to slowdown or reduce its progression," Santarelli said.

"This approach is consistent with our strategy in other neurodegenerative diseases, such as alzheimer’s, Huntington, multiple sclerosis or spinal muscular atrophy, where we target the molecular pathophysiology and intervene early with the objective to slowdown or halt the progression of disease."

PRX002 is currently in preclinical development and is scheduled to enter Phase I clinical trials in patients with PD in 2014.

Alpha-synuclein is one protein from Synuclein proteins, a family of charged proteins found throughout the body.

Found extensively in neurons, alpha-synuclein is claimed to be a major component of pathological inclusions that characterise several neurodegenerative disorders such as PD, dementia with Lewy bodies, neurodegeneration with brain iron accumulation type 1, and multiple system atrophy, which collectively are termed synucleinopathies.

Prothena president and chief executive officer Dale Schenk said: "By combining Roche’s expertise with our own, this collaboration will greatly enhance our development efforts with PRX002 and allow us to move forward in a more comprehensive manner."

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