Novartis Will Co-Develop UCB’s Alpha-Syn Inhibitor For Parkinson’s
Executive Summary
Deal Snapshot: Seeking to bring a disease-modifying Parkinson’s drug to market, Novartis will team with UCB on developing and commercializing UCB0599, a Phase II oral alpha-synuclein inhibitor.
Who: Novartis/UCB
What: Novartis will co-develop and co-commercialize a potentially disease-modifying, small molecule Parkinson’s disease drug that UCB has in Phase II.
Why: Novartis is wagering that inhibiting alpha-synuclein pathology could provide a way to halt progression of Parkinson’s, differing from currently approved therapies that only address disease symptoms.
Financials: Novartis is paying UCB $150m up front, with potential for earnouts up to $1.5bn.
Analysis: In tandem with its R&D day presentation on 2 December, Novartis AG announced that it is licensing co-development and co-commercialization rights to UCB0599, a Phase II oral, potentially disease-modifying alpha-synuclein inhibitor for Parkinson’s disease from UCB S.A. The big pharma will pay UCB $150m up front under the deal, which also confers option rights to a second Parkinson’s candidate, the Phase I alpha-syn-targeting monoclonal antibody UCB7853.
During the R&D call, Novartis’s global head-neuroscience development unit Norman Putski called UCB0599 “the leading oral molecule targeting alpha-synuclein misfolding.” Alpha-syn pathology is an increasingly competitive development space in neurodegenerative disease, being investigated by companies including Roche Holding AG, Prothena Corporation plc, AbbVie Inc. and BioArctic AB for both Parkinson’s and Alzheimer’s disease. (Also see "Parkinson’s Disease: Novel Science And Collaborations Fuel Progress" - In Vivo, 22 Nov, 2019.)
Putski called the deal “a great strategic fit” for Novartis’s ambition to develop and market disease-modifying therapies for severe neurodegenerative disease. “Alpha-synuclein is a super exciting target for Parkinson's disease modification,” he said. “It is neuropathologically and genetically validated and in animal models [of UCB0599], we have seen really strong data. We have seen reduced alpha-synuclein, we have seen an increase of dopamine transporters and we’ve also seen an improved motor function in these models.”
Under the deal, UCB can earn up to $1.5bn in development, regulatory and sales-based milestone fees. The companies will co-fund development of UCB0599 going forward, and Novartis can opt in to co-develop UCB7853 if it likes what it sees when Phase I data report out. The partners will split commercialization responsibilities, with Belgium-based UCB handling Europe and Japan, while Novartis will take the US and rest-of-world responsibilities. The deal announcement does not reference any cross-royalty rights for either company.
Novartis’s pipeline currently lists no clinical candidates for Parkinson’s disease. In 2013, the firm ended development of mavoglurant (AFQ056), an oral metabotropic glutamate 5 (mGluR5) antagonist for Parkinson’s dyskinesia, after the candidate failed to show efficacy in Phase II trials. (Also see "Novartis drops PhII Parkinson's program" - Scrip, 23 Oct, 2013.)