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Product › Details

UCB0599 (Novartis / UCB / Neuropore Therapies)

Period Status 2021-12-02 development p2 existent
Organisation Organisation UCB S.A. (Euronext: UCB)
  Group UCB (Group)
     

UCB S.A.. (12/2/21). "Press Release: UCB Announces Global Partnership to Bring Disease-modifying Therapies to People Living with Parkinson’s Disease". Brussels.

> UCB to partner with Novartis on development of UCB0599 with an opt-in to develop UCB7853, two innovative and potentially disease-modifying investigational assets in Parkinson’s disease

> UCB will receive upfront payment of US$150 million and is eligible to receive further milestone payments with a total potential consideration approaching US$1.5 billion

> Partnership an important step in the development of innovative therapies for the treatment of people living with Parkinson’s disease


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).


About UCB

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


For further information contact:

Nick Francis
Global Communications, UCB
T+44.7769.307745
nick.francis@ucb.com

Antje Witte
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Dr. Alex Klein
Investor Relations, UCB
T +32.2.559.99.48
alex.klein@ucb.com

Laurent Schots
Media Relations, UCB
T+32.2.559.92.64 Laurent.schots@ucb.com


Forward looking statements UCB

This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.


References

1. 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.

2. Smit JW, Maguire RP, Avbersek A et al. UCB0599 transition to the clinic: An orally available brain-penetrant inhibitor of asynuclein (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.

3. Bendor JT, Logan TP, Edwards RH. The function of alpha-synuclein. 2013, Vol. 79, pp. 1044-1066.

4. Meade RM, Fairlie DP, Mason JM. Alpha-synuclein structure and Parkinson’s disease - lessons and emerging principles. 2019, Vol. 14(1), p. 29.

5. 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.

6. UCB Biopharma. Orchestra. About Clinical Studies. [Online] 2021. https://orchestra-study.com/about-clinical-studies/.

7. 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.

   
Record changed: 2021-12-04

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