1.2 Key events1From 1 January 2019 up to the publication of date of this report.
1.2 Key events1From 1 January 2019 up to the publication of date of this report.
There have been a number of key events that have affected or will affect UCB financially:
1.2.1 Important agreements/initiatives
- February 2019 – The UCB real estate ‘Creative Campus Monheim’ in Monheim (Germany) was divested to the city of Monheim. The actual transfer of the site took place on 1 February 2019. The Creative Campus Monheim is the site for 10 companies in the life sciences sector, including UCB. UCB has now leased its respective space long-term. The city of Monheim plans to further develop and expand the campus.
- February 2019 – UCB and the Epilepsy Society, the leading epilepsy medical charity in the UK, announced a pioneering UK Genomics R&D collaboration. The five-year € 2.5 million R&D collaboration seeks to advance the current disease understanding and aims to progress treatment options by harnessing cutting edge science and data analysis to address a significant unmet need for patients living with epilepsy who do not respond to currently available medicines.
- February 2019 – UCB expanded its global satellite research site strategy by signing a new three-year research and development collaboration agreement with King’s College London (UK). This collaboration with King’s also builds upon the recent successful execution of three satellite research sites in the U.S. resulting from acquisitions of Beryllium (Boston and Seattle) and Element Genomics (Durham, NC) which will boost UCB’s capabilities in genomics, protein engineering and structural biology.
- March 2019 – UCB divested its Niferex® (iron supplement) franchise in China. Niferex® generated net sales of € 24 million in 2018 and € 6 million in 2019.
- July 2019 – Consortium project grant agreement signed: SeizeIT – a pan-European consortium under UCB’s leadership – is currently developing a discrete, personalized epileptic seizure detection device, that paves the way for the continuous collection of real-world data with application for UCB’s epilepsy clinical trial programs. A clinical trial-ready device is scheduled for incorporation in UCB’s epilepsy studies from 2020 onwards. UCB is committed to transform Epilepsy treatment by leveraging the convergence of science and technology. The SeizeIT consortium secured a grant of € 2.75 million from EIT Health; a public-private partnership in health, which is supported by the European Institute for Innovation & Technology (EIT), a body of the European Union.
- October 2019 – UCB agrees to acquire Ra Pharmaceuticals: Under the terms of the agreement, Ra Pharma shareholders would receive USD 48 in cash for each Ra Pharma share at closing (approximately USD 2.5 billion / € 2.2 billion). Total transaction value of approximately USD 2.1 billion / € 2.0 billion (net of Ra Pharma cash). The Boards of Directors of both companies have unanimously approved the transaction, and at a special meeting which took place on 17 December 2019, the Ra Pharma shareholders approved a proposal to adopt the merger agreement. Closing remains subject to receipt of required antitrust clearances. UCB expects to receive all such antitrust clearances and to close the transaction by the end of Q1 2020.
Upon closing, this acquisition would enhance UCB’s leadership potential in myasthenia gravis by adding zilucoplan, a peptide inhibitor of complement component 5 (C5) currently in Phase 3, to the UCB pipeline alongside to UCB’s rozanolixizumab, an FcRn targeting antibody also in Phase 3. zilucoplan is a novel, potentially best-in-class investigational molecule also being evaluated in other complement-mediated diseases including amyotrophic lateral sclerosis (ALS) and immune-mediated necrotizing myopathy (IMNM). UCB will develop and, if approved, plans to launch zilucoplan worldwide, accelerating and diversifying company growth. The acquisition of Ra Pharma will also accelerate UCB’s long-term innovation capabilities through the addition of Ra Pharma’s proprietary ExtremeDiversity™ technology platform. The acquisition will enable accelerated top and bottom line growth for UCB from 2024 onwards.
1.2.2 Regulatory update and pipeline progress
- January 2019 – Vimpat® (lacosamide) was approved in Japan for the treatment of partial onset seizures in children 4 years of age and older. In addition, two new formulations were approved, IV (intravenous) and dry syrup.
In June, the Vimpat® development program for the adjunctive treatment of primary generalized tonic-clonic seizures (PGTCS) in study participants 4 years of age and older achieved statistically significant positive results for both its primary (time to second seizure) and secondary efficacy (seizure freedom) endpoints. The novel primary endpoint “time-to-second-seizure” reduced placebo-exposure of patients substantially. Submissions of this new indication are planned in H1 2020 to multiple regulatory agencies.
- March 2019 – UCB started an international (U.S., EU, Japan and China) Phase 3 study with padsevonil in drug-resistant focal epilepsy patients. First headline results are expected in H2 2021 and will complement those from the ongoing Phase 2b, expected in H1 2020. padsevonil is an innovative drug purposely designed with a novel dual mechanism of action to address the needs of uncontrolled patients.
- March 2019 – UCB started as planned a Phase 2, proof-of concept, study with its novel, subcutaneous FcRn (neonatal Fc receptor) monoclonal antibody, rozanolixizumab, in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). First headline results are expected in H1 2021.
In June, UCB started as scheduled the confirmatory study (Phase 3) with rozanolixizumab in patients with myasthenia gravis. First headline results are expected in H1 2021.
In January 2020, the Phase 3 study with rozanolixizumab in patients with immune thrombocytopenia (ITP) started, first headline results are expected in H2 2022.
- May 2019 – Nayzilam® (midazolam) nasal spray was approved in the U.S. to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy. UCB acquired the rights to midazolam nasal spray from Proximagen in June 2018. UCB launched Nayzilam® Nasal Spray CIV, the first nasal rescue treatment for seizure clusters in the U.S., in December 2019.
- September 2019 – New data from a Phase 1 study indicated that UCB0107 anti-Tau was well tolerated with an acceptable safety profile. UCB aims to initiate an adequate and well controlled study in Q2 2020. UCB0107 is currently being investigated as a potential treatment for patients with tauopathies, initially focusing on progressive supranuclear palsy (PSP).
- October 2019 – Keppra® (levetiracetam) was approved, in the U.S., for monotherapy in partial onset seizures. The new indication is intended for the use of Keppra® as monotherapy in treatment of partial-onset seizures in patients 1 month of age and older and with an updated labeling to comply with the Pregnancy and Lactation Labeling Rule (PLLR). An important driver for this submission was adding patient value, especially for pregnant women or women of childbearing age.
- March 2019 – UCB announced the approval of Cimzia® (certolizumab pegol) in the U.S. to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
In July, Cimzia® was approved in China in combination with methotrexate for the treatment of moderate to severe, active rheumatoid arthritis in adult patients.
In December, Cimzia® for the treatment of psoriasis and psoriatic arthritis was approved in Japan.
- March & April 2019 – The Phase 3 programs with bimekizumab in psoriatic arthritis and axial spondyloarthritis were initiated. First headline results are expected at the end of 2021.
During the course of the fourth quarter 2019, UCB reported positive results for three Phase 3 studies with bimekizumab in psoriasis:
- In October, the study BE VIVID, evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe chronic plaque psoriasis met all primary and ranked secondary endpoints, including significantly greater efficacy compared to ustekinumab.
- In November, the study BE READY, evaluating the efficacy and safety of bimekizumab versus placebo in adults with moderate-to-severe chronic plaque psoriasis, met all primary and ranked secondary endpoints.
- In December, the study BE SURE, comparing bimekizumab to adalimumab for the treatment of adults with moderate-to-severe plaque psoriasis, met all co-primary and ranked secondary endpoints, achieving significantly greater efficacy than adalimumab.
Based on the positive proof-of-concept study, UCB decided to move into late stage development with bimekizumab also in moderate to severe hidradenitis suppurativa (HS), a severe inflammatory skin disease, affecting predominantly women. The Phase 3 program BE HEARD starts in Q1 2020. First headline results are expected in H1 2023.
- June 2019 – UCB and its partner Biogen initiated preparations for a Phase 3 program with dapirolizumab pegol in patients with active systemic lupus erythematosus despite standard-of-care treatment. The program is expected to start in H1 2020. This decision is based on the promising results of the Phase 2b clinical trial, of which interim results were presented at EULAR in June 2019.
- The Phase 1 project UCB0159 was terminated.
- Early January 2019 – UCB and Amgen announced the approval of Evenity® (romosozumab) in Japan. Evenity® is approved to reduce the risk of fractures and increase bone mineral density in men and post-menopausal women with osteoporosis at high risk of fracture.
In April, Evenity® was approved in the U.S. for the treatment of osteoporosis in post-menopausal women at high risk for fracture.
In May, Evenity® was approved in South Korea followed by Canada and Australia in June.
- June 2019 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a negative opinion for romosozumab. The companies sought the re-examination of the CHMP opinion.
In October, following re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization. Evenity® was approved by the EMA in December for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
All other clinical development programs are continuing as planned.
1 From 1 January 2019 up to the publication of date of this report.