UCB Announces Global Partnership to Bring Disease-Modifying Therapies to People Living with Parkinson’s Disease
Brussels, Belgium – 2 December, 2021, 7:15 CET – UCB today announced that it has entered into a global co-development and co-commercialization agreement with Novartis covering UCB0599, a potential first in class, small molecule, alpha-synuclein misfolding inhibitor currently in Phase 2 clinical development, and upon completion of the ongoing Phase 1 program, an opt-in to co-develop UCB7853, an anti-alpha-synuclein antibody, both in Parkinson’s Disease (PD).
“This partnership has the potential to be transformational for people living with Parkinson’s disease, as it will combine UCB’s expertise as a leader in the field of neurodegenerative disease with Novartis’ global capabilities and deep experience developing transformative, disease modifying treatments for a range of neurological conditions,” said Dhaval Patel, Executive Vice President and Chief Scientific Officer at UCB. “It is a great example of our approach to research and development in neurodegeneration, building external networks and partnerships to access additional capabilities and knowledge, that help to accelerate the development of our medicines.”
Charl van Zyl, Executive Vice President, Neurology & Head of Europe/International Markets commented: “It is our long-term ambition to transform the Parkinson’s treatment landscape from the management of symptoms, to treatments that can slow or stop the progression of disease. By sharing resources and working together we think we can best optimize our chances of success and realize our Parkinson’s ambitions.”
Under the terms of the agreement, the parties will co-develop and co-fund the further global development of UCB0599. Novartis also have the right to “opt-in” to engage in global co-development of UCB7853 upon completion of a Phase 1 study currently being run by UCB. Further clinical development would then also be jointly funded and managed.
UCB will receive an upfront payment of US$150 million and is eligible to receive further potential payments with a total consideration approaching US$1.5 billion upon receipt of certain regulatory approvals and satisfying certain development and sales related milestones. If approved, commercial responsibilities will be split, with UCB being the marketing authorization holder and commercial lead in Europe and Japan, and Novartis in the US and all other territories.
This agreement does not impact UCB’s 2021 financial guidance.
About UCB0599 and UCB7853
UCB0599 was in-licensed by UCB from Neuropore Therapies Inc. (1) It is an orally administered, brain penetrant, small molecule inhibitor of alpha-synuclein misfolding under clinical investigation for the potential to slow the progression on Parkinson’s (2). UCB7853 is an anti-alpha-synuclein monoclonal antibody under investigation for the potential treatment of people living with Parkinson’s.
The most prominent neuropathological hallmark of Parkinson’s is the abnormal accumulation and misfolding of the alpha-synuclein protein. This misfolding is thought to be a primary step in the pathological cascade that results in the progression of Parkinson’s disease pathobiology culminating in the loss of neurons (3; 4).
Through action on this early step in Parkinson’s pathology, UCB0599 may have the potential to slow the progression of the disease and related clinical symptoms. A complementary approach may be achieved by targeting the extracellular spread of pathological species of alpha-synuclein with antibody therapies such as UCB7853. Collectively, UCB0599 and UCB7853 represent a unique opportunity to target a key pathobiology in Parkinson’s and offer the potential to bring transformative treatments to patients (5; 6; 7).
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,300 people in approximately 40 countries, UCB generated revenue of € 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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- UCB Biopharma. UCB Initiates Phase 1b US-Based Multicenter Clinical Trial in Parkinson’s Disease Patients with UCB0599, a Compound Arising from the Neuropore-UCB Collaboration. [Online] 2021. https://www.neuropore.com/media/news/neuropore-initiates-phase-1-clinical-trial-in-healthy-volunteers-with-npt52034-a-therapeutic-candidate-aimed-at-treating-parkinsons-disease-and-amyotrophic-lateral-sclerosis9672.htm.
- Smit JW, Maguire RP, Avbersek A et al. UCB0599 transition to the clinic: An orally available brain-penetrant inhibitor of αsynuclein (ASYN) misfolding in Phase 1 development for Parkinson’s disease (PD). MDS Virtual Congress September 12–16 Late-breaking abstract;LBA4. [Online] 2020. https://www.movementdisorders.org/Congress-Branded/Congress-2020-Files/MDSVirtualCongressLateBreakingAbstracts1.pdf.
- Bendor JT, Logan TP, Edwards RH. The function of alpha-synuclein. 2013, Vol. 79, pp. 1044-1066.
- Meade RM, Fairlie DP, Mason JM. Alpha-synuclein structure and Parkinson’s disease - lessons and emerging principles. 2019, Vol. 14(1), p. 29.
- ClinicalTrials.gov. A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD). NCT04651153. [Online] 2020. https://clinicaltrials.gov/ct2/show/NCT04651153?term=UP0092&draw=2&rank=1.
- UCB Biopharma. Orchestra. About Clinical Studies. [Online] 2021. https://orchestra-study.com/about-clinical-studies/.
- ClinicalTrials.gov. A 18-month Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson's disease. [Online] 2020. https://clinicaltrials.gov/ct2/show/NCT04658186?term=PD0053&draw=2&rank=1.
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