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Prothena spins out of Elan

This article was originally published in Scrip

Executive Summary

Elan has carried out the demerger of its drug discovery activities into a new company, which it has named Prothena. The operation, which the firm announced back in August when its Phase III Alzheimer's antibody, intravenous bapineuzumab, partnered with Janssen and Pfizer, failed in a pivotal trial, conducted by Janssen (scripintelligence.com, 7 August 2012, 13 August 2012 and 15 August 2012).

Elan has carried out the demerger of its drug discovery activities into a new company, which it has named Prothena. The operation, which the firm announced back in August when its Phase III Alzheimer's antibody, intravenous bapineuzumab, partnered with Janssen and Pfizer, failed in a pivotal trial, conducted by Janssen (scripintelligence.com, 7 August 2012, 13 August 2012 and 15 August 2012).

Prothena combines the two activities of two pre-existing Elan subsidiaries, Neotope Biosciences and Onclave Therapeutics. Its shares are 100% owned (82% directly and 18% indirectly through a wholly owned Elan subsidiary) by Elan's existing shareholders.

Elan capitalised the new firm with a cash investment of $99 million in its legacy subsidiaries prior to the demerger; this fell short of the $120-130 million it had indicated it would invest when the business split was announced.

The new business will focus on antibody therapies for diseases that involve protein misfolding or cell adhesion. Its most advanced projects include NEOD001, an amyloid-targeting monoclonal antibody which the firm hopes to progress into Phase I studies in the rare disorder AL amyloidosis in early 2013, and NEOD002, an alpha-synuclein-targeting antibody for Parkinson's disease and other synucleinopathies which is in preclinical development.

Prothena's CEO is Dr Dale Schenk, an expert in immunotherapeutic approaches to amyloid conditions and previously Elan's chief scientific officer. Before that, he founded Athena Neurosciences, which Elan acquired.

The firm is listed on Nasdaq.

Elan's Pipeline

Aside from its interest in the residual development work being done by Janssen in Alzheimer's immune therapy (a subcutaneous version of bapineuzumab is in Phase II studies, as is ACC-001, an experimental vaccine for the disease), Elan's main R&D focus is now on expanding the indications for Tysabri (natalizumab), the blockbuster multiple sclerosis drug that is partnered with Biogen Idec.

It is also developing a small molecule beta amyloid anti-aggregation agent, ELND005, of which Elan commenced a Phase II trial in August, as an adjunctive maintenance treatment in bipolar I disorder to delay the time to occurrence of mood episodes. The product previously failed in Alzheimer's studies.

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