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Market Spotlight: Systemic Lupus Erythematosus (SLE)

Market Spotlight: Systemic Lupus Erythematosus (SLE)

  • October 2019
  • 54 pages
  • ID: 5807904
  • Format: PDF
  • By Pharma Intelligence


Table of Contents

This Market Spotlight report covers the SLE market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, patent information, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways
The approved drugs in the systemic lupus erythematosus (SLE) space target B-cell activating factor, glucocorticoid receptor, corticotropin releasing factor, and corticotropin releasing hormone. These drugs are administered via the subcutaneous, intravenous, intramuscular, and oral routes.
The majority of industry-sponsored drugs in active clinical development for SLE are in Phase II. Therapies in mid-to-late-stage development for SLE focus on a wide variety of targets. The majority of pipeline drugs in mid- and late-stage development are administered via the subcutaneous route, with the remainder being intravenous, oral, and intramuscular formulations.
High-impact upcoming events for drugs in the SLE space comprise topline Phase II trial results for BIIB059, GS-9876, evobrutinib, lenabasum, and RSLV-132; topline Phase III trial results for Benlysta; and an expected patent expiration for INV103.
The overall likelihood of approval of a Phase I SLE asset is 4.9%, and the average probability a drug advances from Phase III is 44.4%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
There have been 15 licensing and asset acquisition deals involving SLE drugs during 2014–19. The largest deal during the period was the $690m exclusive collaboration and license agreement signed in 2015 between Eli Lilly and Hanmi Pharmaceutical to develop and commercialize HM71224 for potential treatment of rheumatoid arthritis, lupus, lupus nephritis, Sjögren’s syndrome, and other related conditions.
The distribution of clinical trials across Phase I–IV indicates that the majority of trials for SLE have been in the early and midphases of development, with 68% of trials in Phase I–II, and 32% in Phase III–IV.
The US has a substantial lead in the number of SLE clinical trials globally. Germany leads the major EU markets, while South Korea has the top spot in Asia.
Clinical trial activity in the SLE space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for SLE, with 27 trials.
GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca

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