Horizon Therapeutics plc Announces New Development Programs at Virtual R&D Day
Horizon Therapeutics announces the addition of five new development programs for investigational medicines Daxdilimab (HZN-7734) and Dazodalibep (HZN-4920), expanding its pipeline to a total of 27 programs. The new trials focus on conditions like alopecia areata, dermatomyositis, and lupus nephritis. With 10 data readouts expected by 2023, the company believes its robust pipeline may represent approximately $10 billion in peak annual net sales. The virtual R&D Day event marks a strategic step in Horizon's long-term growth trajectory.
- Expansion of pipeline to 27 development programs with five new trials.
- Potential for ~$10 billion in total peak annual net sales from the robust pipeline.
- New trials target diseases with significant unmet medical needs.
- None.
-- Announcing Five Total New Development Programs for Daxdilimab (HZN-7734) and Dazodalibep (HZN-4920); Expect to Initiate New Phase 2 Trials in 2022, Bringing Total Development Programs to 27 --
--Positioned for Growth with Expanding R&D Team, New Disease Areas and Manufacturing Capability--
-- 10 Data Readouts Across Development Programs Expected Through 2023 --
-- Robust Pipeline and Diversified Portfolio Represent Potential
-- Event Begins at
The virtual event will be held from
“Horizon’s unique combination of commercial execution, proven and disciplined business development and strong R&D capabilities transformed us into one of the fastest growing, profitable biotechnology companies in the industry,” said
New Development Programs
With the addition of five new development programs, Horizon now has 27 development programs across its pipeline. Daxdilimab (HZN-7734), an investigational, fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7) promoting the destruction of plasmacytoid dendritic cells (pDCs), is currently in a Phase 2 clinical trial for systemic lupus erythematosus. It will also be studied in four new disease areas:
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Alopecia areata
- An autoimmune disorder characterized by nonscarring hair loss. There are no FDA-approved treatments for alopecia areata.
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Dermatomyositis
- A rare, autoimmune disorder characterized by rashes, debilitating muscle weakness and interstitial lung disease. There are no FDA-approved treatments for dermatomyositis.
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Discoid lupus erythematosus
- A rare, chronic, inflammatory skin condition characterized by lesions that result in scarring. There are no FDA-approved treatments for discoid lupus erythematosus.
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Lupus nephritis
- A rare, autoimmune and inflammatory condition of the kidney.
Dazodalibep (HZN-4920), an investigational fusion protein binding CD40L on T cells, blocking their interaction with CD40-expressing B cells, is currently in Phase 2 clinical trials for Sjögren’s syndrome, rheumatoid arthritis and kidney transplant rejection. It will also be studied in one new disease area:
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Focal segmental glomerulosclerosis
- A rare kidney disorder characterized by scarring of glomeruli, or small filters in the kidney, which leads to kidney damage and failure.
All five programs are Phase 2 trials that are expected to begin in 2022.
“Our mission is to serve patients with rare, autoimmune and severe inflammatory diseases and in R&D, we are doing that by putting our focus on understanding and impacting the critical biological pathways underlying these diseases,” said
About Daxdilimab (HZN-7734)
Daxdilimab is a fully human monoclonal antibody that targets ILT7 and has been shown in early studies to promote the destruction of plasmacytoid dendritic cells (pDCs). These cells are thought to play a critical role in the pathogenesis of lupus and other autoimmune diseases through their capacity to produce rapid and robust quantities of Type 1 Interferons (IFN) as well as through IFN-independent mechanisms.
About Dazodalibep (HZN-4920)
Dazodalibep is a novel, non-antibody fusion protein that blocks CD40 ligand (CD40L) activity that has been shown to reduce B cell activation and autoantibody production, potentially halting inflammation and autoimmunity. CD40 is a well-established receptor pathway that contributes to autoimmune and inflammatory disease when it binds to the CD40L, causing B cell and T cell interaction that creates inflammation and disease. This can lead to conditions such as Sjögren’s syndrome and other autoimmune diseases.
About Horizon
Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to Horizon’s clinical development plans; timing of clinical data; potential peak net sales of Horizon’s medicines and medicine candidates; expected financial performance and operating results in future periods, including potential growth; the potential benefits of Horizon’s medicine candidates; and business and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon’s actual future financial and operating results may differ from its expectations or goals; impacts of the COVID-19 pandemic and actions taken to slow its spread, including impacts on supplies and net sales of Horizon’s medicines and potential delays in clinical trials; risks associated with the manufacture of biologic medicines; risks relating to Horizon’s ability to successfully implement its business strategies, including its development, manufacturing and global expansion strategies; risks inherent in developing novel medicine candidates and existing medicines for new indications, including the risk that future clinical trials are not successful or are delayed; risks associated with regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon’s filings and reports with the
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