Product Code: DMKC0206778
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.
- 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 development for SLE focus on a wide variety of targets. The majority of pipeline drugs 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 evobrutinib, lenabasum, iscalimab, and BMS-986165; topline Phase IIa trial results for RSLV-132; topline Phase III trial results for Benlysta and anifrolumab; and an expected patent expiration for INV103.
- The overall likelihood of approval of a Phase I SLE asset is 3.5%, and the average probability a drug advances from Phase III is 33.3%. 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 17 licensing and asset acquisition deals involving SLE drugs during 2015-20. 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, Sjogren'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 European 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 29 trials.
- GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.
TABLE OF CONTENTS
- Disease definition
- Patient subtypes
- Risk factors
- Nonsteroidal anti-inflammatory drugs (NSAIDs) and pain relievers
- Antimalarial drugs
- Immunosuppressive agents
- Monoclonal antibodies
- Repository corticotropin injection
RECENT EVENTS AND ANALYST OPINION
- BIIB059 for SLE (December 3, 2019)
- Multiple Drugs for SLE (October 24, 2019)
- Anifrolumab for SLE (August 29, 2019)
- CC-11050 for SLE (August 26, 2019)
- Lupuzor for SLE (June 28, 2019)
- IFNa Kinoid for SLE (April 6, 2019)
- Dapirolizumab Pegol for SLE (October 23, 2018)
- XmAb5871 for SLE (October 5, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Benlysta Becomes First Approved Treatment For Pediatric Lupus
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Overview of pipeline drugs for SLE in the US
- Figure 2: Pipeline drugs for SLE, by company
- Figure 3: Pipeline drugs for SLE, by drug type
- Figure 4: Pipeline drugs for SLE, by classification
- Figure 5: BIIB059 for SLE (December 3 2019): Phase II - LILAC
- Figure 6: Anifrolumab for SLE (August 29, 2019): Phase III - TULIP SLE 2 (IV)
- Figure 7: Dapirolizumab Pegol for SLE (October 23, 2018): Phase IIb - SL0023
- Figure 8: XmAb5871 for SLE (October 5, 2018): Phase II - XmAb5871-04
- Figure 9: Key upcoming events in SLE
- Figure 10: Probability of success in the SLE pipeline
- Figure 11: Licensing and asset acquisition deals in SLE, 2015-20
- Figure 12: Parent patents in SLE
- Figure 13: Clinical trials in SLE
- Figure 14: Top 10 drugs for clinical trials in SLE
- Figure 15: Top 10 companies for clinical trials in SLE
- Figure 16: Trial locations in SLE
- Figure 17: SLE trials status
- Figure 18: SLE trials sponsors, by phase
LIST OF TABLES
- Table 1: Marketed drugs for SLE
- Table 2: Pipeline drugs for SLE in the US
- Table 3: BIIB059 for SLE (December 3, 2019)
- Table 4: Multiple Drugs for SLE (October 24, 2019)
- Table 5: Anifrolumab for SLE (August 29, 2019)
- Table 6: CC-11050 for SLE (August 26, 2019)
- Table 7: Lupuzor for SLE (June 28, 2019)
- Table 8: IFNa Kinoid for SLE (April 6, 2019)
- Table 9: Dapirolizumab Pegol for SLE (October 23, 2018)
- Table 10: XmAb5871 for SLE (October 5, 2018)
- Table 11: Historical global sales, by drug ($m), 2014-18
- Table 12: Forecasted global sales, by drug ($m), 2020-24