This Market Spotlight report covers the Hidradenitis Suppurativa market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, key upcoming and regulatory events, probability of success, patent information, epidemiology, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
All of the approved drugs for hidradenitis suppurativa (HS) target tumor necrosis factor-alpha. These therapies are administered via the subcutaneous route, while Humira is also available in an intravenous formulation.
The majority of industry-sponsored drugs in active clinical development for HS are in Phase II. Therapies in development for HS target tumor necrosis factor-alpha, interleukin-17, interleukin-1, interleukin-23, JAK/STAT, cluster of differentiation 40, and the C5a receptor. These therapies are administered via the oral, intravenous, and subcutaneous routes.
High-impact upcoming events for drugs in the HS space comprise topline Phase II trial results for Avacopan and Iscalimab. The overall likelihood of approval of a Phase I dermatology-general asset is 25.2%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 8.1 years from Phase I to approval in the dermatology-general space, as well as in the overall dermatology space.
There have been only eight licensing and asset acquisition deals involving HS drugs during 2015-20. The $750m definitive agreement signed in December 2019 between Janssen Pharmaceutical and Xbiotech, under which Janssen Pharmaceutical has acquired all rights to Xbiotech's bermekimab, an anti-IL-1alpha monoclonal antibody (mAb) in Phase II development for the treatment of atopic dermatitis and HS, was the largest deal.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for HS have been in the early and midphases of development, with 83% of trials in Phase I-II, and only 17% in Phase III-IV.
The US has the lead in terms of the number of HS clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
AbbVie and Abbott have the highest number of completed clinical trials for HS, with two trials each.
AbbVie is the only sponsor to have initiated a Phase III and Phase IV trial in HS.
TABLE OF CONTENTS
RECENT EVENTS AND ANALYST OPINION
- IFX-1 for HS (November 6, 2019)
- IFX-1 for HS (July 18, 2019)
- IFX-1 for HS (June 5, 2019)
- SensoReady Injector Pen for HS (April 9, 2019)
- Bermekimab for HS (January 23, 2019)
KEY UPCOMING EVENTS
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Janssen Licenses Global Rights To XBiotech's Bermekimab
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
LIST OF FIGURES
- Figure 1: Overview of pipeline drugs for HS in the US
- Figure 2: Pipeline drugs for HS, by company
- Figure 3: Pipeline drugs for HS, by drug type
- Figure 4: Pipeline drugs for HS, by classification
- Figure 5: IFX-1 for HS (June 5, 2019): Phase IIb - SHINE
- Figure 6: Bermekimab for HS (January 23, 2019): Phase II - Open Label
- Figure 7: Key upcoming events in HS
- Figure 8: Probability of success in the HS pipeline
- Figure 9: Licensing and asset acquisition deals in HS, 2015-20
- Figure 10: Clinical trials in HS
- Figure 11: Top 10 drugs for clinical trials in HS
- Figure 12: Top 10 companies for clinical trials in HS
- Figure 13: Trial locations in HS
- Figure 14: HS trials status
- Figure 15: HS trials sponsors, by phase
LIST OF TABLES
- Table 1: Marketed drugs for HS
- Table 2: Pipeline drugs for HS in the US
- Table 3: IFX-1 for HS (November 6, 2019)
- Table 4: IFX-1 for HS (July 18, 2019)
- Table 5: IFX-1 for HS (June 5, 2019)
- Table 6: SensoReady Injector Pen for HS (April 9, 2019)
- Table 7: Bermekimab for HS (January 23, 2019)
- Table 8: Parent patents in HS
- Table 9: Historical global sales, by drug ($m), 2014-18
- Table 10: Forecasted global sales, by drug ($m), 2020-24