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UCB SA UNSP/ADR (UCBJY) is a global biopharmaceutical company focused on developing innovative medicines for immune system and central nervous system diseases. Recent achievements include 48-week post-hoc analyses of pooled Phase 3 data from the BE HEARD I and BE HEARD II studies for hidradenitis suppurativa patients, showing clinically meaningful improvements in skin pain and draining tunnels with BIMZELX treatment. The company is actively pursuing regulatory applications globally for the approval of BIMZELX.
A new research analysis by UCB focuses on the lived experience of myasthenia gravis (MG), detailing patient insights published in Neurology and Therapy. Conducted by a Patient Council of nine advocates from Europe and the U.S., the study highlights significant themes affecting MG patients, including treatment inertia, communication gaps with physicians, and the emotional burden of the disease. Despite MG's rarity, with 8-10 cases per million annually, the incidence is rising due to better diagnostics. The study encourages improved dialogue and understanding between patients and healthcare providers.
UCB, on World Osteoporosis Day 2021, announced a strategic out-licensing of its AI fracture identification technology, BoneBot, to ImageBiopsy Lab. This collaboration aims to integrate AI into clinical practice by 2023, enhancing the detection of asymptomatic spinal fractures via CT scans. Osteoporosis affects around 200 million people globally, leading to 9 million fragility fractures annually. This partnership reflects UCB's commitment to addressing the needs of osteoporosis patients and improving healthcare outcomes through innovative technology.
UCB announced it could not complete the FDA review of the Biologics License Application for bimekizumab by the October 15, 2021 PDUFA date due to COVID-19 travel restrictions affecting necessary facility inspections. The BLA remains under review, and UCB is in contact with the FDA to schedule inspections. Bimekizumab received marketing authorization in the EU and Great Britain in August 2021 and remains under regulatory review in several other countries. UCB's financial guidance for 2021 and 2025 remains unchanged.
UCB has announced promising interim results from the BE BRIGHT study, evaluating the long-term safety and efficacy of bimekizumab for patients with moderate to severe plaque psoriasis. Presented at the 30th EADV Congress, the data revealed sustained skin clearance rates (PASI 90: 89.4% at week 104) and tolerability over two years. The findings indicate effective transition from other treatments, enhancing treatment options and patient outcomes. UCB remains committed to improving psoriasis care as they await FDA approval for bimekizumab.
UCB announced the publication of key findings from Phase 3 studies BE RADIANT and BE SURE in The New England Journal of Medicine. These studies evaluated the effectiveness of bimekizumab, an investigational IL-17A and IL-17F inhibitor, for moderate to severe plaque psoriasis. Results indicated that 61.7% of patients achieved complete skin clearance (PASI 100) at week 16 with bimekizumab, compared to 48.9% with secukinumab (p<0.001). Safety profiles showed a consistent rate of treatment-emergent adverse events, including upper respiratory infections. The drug remains unapproved by regulatory authorities.
UCB announced the presentation of 12 abstracts on bimekizumab, an investigational IL-17A and IL-17F inhibitor, at the American Academy of Dermatology Virtual Meeting Experience 2021 from April 23-25. This includes an oral presentation of late-breaking data from the Phase 3b BE RADIANT study, comparing bimekizumab's efficacy and safety to secukinumab for treating moderate to severe plaque psoriasis. The data focus on treatment response, efficacy across subgroups, and patient quality of life. Notably, bimekizumab is still under investigation and not yet approved.
Insilico Medicine announced the integration of its Chemistry42™ platform into UCB's drug discovery pipeline, enhancing UCB's ability to design new hit compounds efficiently. This collaboration aims to reduce costs and streamline the drug development process. Chemistry42™ will be customized for UCB's cloud-based supercomputing infrastructure, enabling rapid, user-defined druglike properties formulation. UCB's commitment to AI-powered drug discovery further solidifies its leadership in the biopharmaceutical sector.
UCB reported strong 2020 financial results with revenues of €5.3 billion, reflecting a 9% increase. Key products drove an 8% growth in net sales, totaling €5.1 billion. Adjusted EBITDA reached €1.4 billion, but net profit decreased to €761 million. The company plans to pay a dividend of €1.27 per share. UCB aims to achieve revenues of over €6 billion by 2025 despite patent expirations, focusing on its promising pipeline. Recent acquisitions enhance its gene therapy capabilities, while sustainability remains integral to its strategy.
UCB and Microsoft announced a strategic collaboration to enhance drug discovery through AI and cloud computing. This partnership aims to expedite the development of medicines, particularly in immunology and neurology, by leveraging Microsoft's computational capabilities alongside UCB's scientific expertise. The collaboration builds on previous efforts, such as the COVID Moonshot project, and targets improving patient experiences, understanding disease biology, and accelerating clinical timelines. CEO Jean-Christophe Tellier emphasized the intent to create personalized medicine through digital transformation.
UCB and Aetion have entered into a partnership to enhance UCB's use of real-world evidence (RWE) through advanced analytics. This agreement aims to support value-based contracting across UCB's portfolio in the U.S. market, particularly in immunology and neurology. UCB's Executive Vice President highlighted that this collaboration will expedite the analysis of health data, improving patient outcomes and medication value assessment. UCB views RWE as a key part of its market access strategy, matching transparency with healthcare payment models.
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