Disease Analysis: Ulcerative Colitis
Publisher: Datamonitor Healthcare
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Disease Overview
Ulcerative colitis (UC) is a form of chronic inflammatory bowel disease (IBD), which causes mucosal inflammation affecting the colon. The idiopathic inflammation is commonly associated with the rectum (proctitis) and may extend proximally, evolving into left-sided colitis or extensive colitis (see the figure below). UC typically presents with bloody diarrhea, which may manifest alongside mucus, rectal urgency, tenesmus, and abdominal pain. The disease course is relapsing and remitting with intermittent periods of acute exacerbation, which may be serious enough to warrant therapy escalation, hospitalization, or even colectomy.
Latest key takeaways
- As specialty products, therapies for ulcerative colitis (UC) can be expensive, and formulary positioning is paramount to product uptake. Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade. This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates. Biosimilar and generic competition will further undermine the likely premium pricing of newer and pipeline products.
- Pivotal upcoming events in the forecast period include the entries of biosimilar adalimumab and generic tofacitinib. Biosimilar adalimumab will enter the US market from 2023, while generic tofacitinib is expected to enter the US market at the end of 2025. Notably, generics have fewer barriers to entry than biosimilars due to numerous factors, including their less complex nature and long-standing familiarity, which facilitates much faster and stronger erosion of branded sales.
- Nevertheless, the UC market is projected to expand, propelled by a growing patient caseload and the introduction of pipeline products. Datamonitor Healthcare estimates that in 2021, there were 13.0 million prevalent cases of UC worldwide, and forecasts that number to increase to 13.5 million prevalent cases by 2027.
- The UC pipeline holds multiple novel prospects in terms of distinct mechanisms of action and biologics with more convenient formulations. The market will welcome sphingosine 1-phosphate (S1P) receptor modulator etrasimod, interleukin-23 (IL-23) modulators mirikizumab and guselkumab, and toll-like receptor (TLR) 9 modulator Kappaproct. There has been a positive response to Xeljanz as the first novel oral drug competing with biologics for UC, and other companies have recognized this opportunity to provide ease of administration, for example with oral etrasimod and Rinvoq. Once these products reach the market, they will provide more options for UC patients beyond the established, non-oral anti-TNF class, which is currently the mainstay of treatment. It is likely that these novel products will initially compete at later lines of therapy after the anti-TNF inhibitors, given the latter’s enduring stronghold at the first line of biologic therapy.
- Zeposia (ozanimod), an S1P receptor modulator, was approved by the US FDA in May 2021 for patients with moderately to severely active UC. Zeposia will hit the market sooner than etrasimod and has a more attractive commercial profile.
- Although the anti-TNF class are the cornerstone of treatment, ~10–30% of patients are non-responders to initial treatment and ~23–46% of patients lose response over time. Additionally, the class has black box warnings for the risk of serious infections and malignancy. These drugs are favored due to long-standing physician familiarity and prioritization in formularies; however, they do not satisfy persisting unmet needs in the UC market.
- Critical unmet needs and opportunities include demonstrating strong efficacy to treat inadequate responders, clinically balanced drugs that offer both efficacy and safety, producing superior data over anti-TNF inhibitors and available drugs in the same class through head-to-head trials, and competitive pricing, which is essential to facilitate better positioning in the treatment algorithm.
- Entyvio is forecast to take top spot in the UC market, with estimated global total brand sales of $4.4bn in 2022 and steady increases over the following years.
- Topline results from the MANTA Phase II study of Jyseleca (filgotinib) demonstrated a numerically lower proportion of Jyseleca patients experiencing a >50% decline in sperm concentration (6.7% vs 8.3% on placebo). This provides initial reassurance for Jyseleca’s prospects in the US following safety concerns pertaining to the 200mg dose that caused the FDA to issue a complete response letter to the approval application in rheumatoid arthritis.
- The most anticipated upcoming events in UC include an NDA/BLA submission for mirikizumab in Q2 2023, and topline results from the Phase III CONCLUDE trial of Kappaproct by the end of 2023.
CONTENTS
9 OVERVIEW
9 Latest key takeaways
11 DISEASE BACKGROUND
11 Definition
11 Patient segmentation
13 TREATMENT
13 ACG treatment guidelines
13 ECCO treatment guidelines
13 NICE treatment guidelines
28 EPIDEMIOLOGY
28 Prevalence methodology
31 MARKETED DRUGS
40 PIPELINE DRUGS
49 KEY REGULATORY EVENTS
49 Stada And Alvotech Launch Higher-Strength Adalimumab In Europe
49 England Okays Funding For Revestive, Jyseleca & Fintepla
49 Sun Outstrips Viatris’ Pentasa Action Date With First ANDA Approval
49 Canada Sees Face-Off Over Higher-Strength Adalimumab
50 Celltrion Launches Higher-Strength Yuflyma Adalimumab In Canada
50 Carogra, Xenpozyme Among Japan World-First Approvals
51 AbbVie Grows Gastrointestinal Business With Rinvoq Approval In UC
51 France’s Abivax Looks A Likely M&A Target
51 Coherus Promises ‘Compelling Value Proposition’ After US Adalimumab Approval
52 Mochida And Ayumi Launch Unique Humira Biosimilar Formulation In Japan
52 New Indication Recommended For Zeposia
52 AbbVie Submits New Rinvoq Use Despite JAK Inhibitor Delays
53 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
53 FDA Accepts ANI’s Refiled Cortrophin Gel
53 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
54 ANI Refiles Cortrophin After Talks With FDA
55 PROBABILITY OF SUCCESS
56 LICENSING AND ASSET ACQUISITION DEALS
56 Hikma Adds Remsima SC To Celltrion MENA Collaboration
56 Pfizer Buys Arena For $6.7bn In Bid To Diversify In Inflammation & Immunology
56 Athos Therapeutics Signs Agreement With Cleveland Clinic
56 AzurRx Will Take First Wave Name After Closing Reverse Merger
57 LianBio Gets Two GI Candidates From Landos
58 CLINICAL TRIAL LANDSCAPE
59 Sponsors by status
60 Sponsors by phase
61 Recent events
66 DRUG ASSESSMENT MODEL
66 Biologic disease-modifying antirheumatic drugs (DMARDs)
69 Non-biologic DMARDs
72 DNA-based immunomodulatory sequence
73 MARKET DYNAMICS
74 FUTURE TRENDS
74 Novel pipeline products are poised to diversify the UC market
74 Brands will face headwinds as the UC market is penetrated by biosimilars and generics
76 CONSENSUS FORECASTS
82 RECENT EVENTS AND ANALYST OPINION
82 AMT-101 for Ulcerative Colitis (July 6, 2022)
83 IMU-838 for Ulcerative Colitis (June 2, 2022)
85 Etrasimod for Ulcerative Colitis (May 24, 2022)
86 Mirikizumab for Ulcerative Colitis (May 24, 2022)
88 CBP-307 for Ulcerative Colitis (May 3, 2022)
90 AMT-101 for Ulcerative Colitis (April 25, 2022)
91 GB004 for Ulcerative Colitis (April 25, 2022)
92 PN-943 for Ulcerative Colitis (April 25, 2022)
93 Etrasimod for Ulcerative Colitis (March 29, 2022)
94 Etrasimod for Ulcerative Colitis (March 23, 2022)
95 Mirikizumab for Ulcerative Colitis (February 18, 2022)
97 Tremfya for Ulcerative Colitis (February 18, 2022)
99 Mirikizumab for Ulcerative Colitis (December 14, 2021)
101 BMS-986165 for Ulcerative Colitis (October 7, 2021)
103 Multiple Drugs for Ulcerative Colitis (September 1, 2021)
105 TD-1473 for Ulcerative Colitis (August 23, 2021)
106 SER-287 for Ulcerative Colitis (July 22, 2021)
108 ABX464 for Ulcerative Colitis (May 24, 2021)
110 Jyseleca for Ulcerative Colitis (March 4, 2021)
112 Rinvoq for Ulcerative Colitis (February 22, 2021)
113 SHR0302 for Ulcerative Colitis (February 4, 2021)
115 AJM300 for Ulcerative Colitis (January 13, 2021)
116 Omilancor for Ulcerative Colitis (January 4, 2021)
118 Jyseleca for Ulcerative Colitis (December 15, 2020)
119 Rinvoq for Ulcerative Colitis (December 9, 2020)
121 KEY UPCOMING EVENTS
122 KEY OPINION LEADER INSIGHTS
123 UNMET NEEDS
123 Treatments that improve the natural history of UC
123 Effective, well-tolerated treatments that induce rapid and sustained remission
123 There is critical unmet need for predictive biomarkers
124 Novel oral treatments
125 BIBLIOGRAPHY
126 APPENDIX
LIST OF FIGURES
11 Figure 33: AJM300 for Ulcerative Colitis (January 13, 2021): Phase III – AJM300/CT3 (Japan)
29 Figure 33: Rinvoq for Ulcerative Colitis (December 9, 2020): Phase IIb/III – U-ACHIEVE
30 Figure 3: Trends in prevalent cases of ulcerative colitis, 2018–27
40 Figure 4: Pipeline drugs for ulcerative colitis, by company
41 Figure 5: Pipeline drugs for ulcerative colitis, by drug type
41 Figure 6: Pipeline drugs for ulcerative colitis, by classification
55 Figure 1: Overview of pipeline drugs for ulcerative colitis in the US
58 Figure 2: Pipeline drugs for ulcerative colitis, by company
58 Figure 3: Pipeline drugs for ulcerative colitis, by drug type
59 Figure 4: Pipeline drugs for ulcerative colitis, by classification
60 Figure 11: Ulcerative colitis trials status
61 Figure 12: Ulcerative colitis trials sponsors, by phase
66 Figure 1: Ulcerative colitis market sales across the US, Japan, and five major European markets, 2016–30
74 Figure 14: Future trends in ulcerative colitis
83 Figure 15: AMT-101 for Ulcerative Colitis (July 6, 2022): Phase II – MARKET (Anti-TNFa Add On)
85 Figure 16: IMU-838 for Ulcerative Colitis (June 2, 2022): Phase II – CALDOSE-1
86 Figure 17: Etrasimod for Ulcerative Colitis (May 24, 2022): Phase III – ELEVATE UC 12, Phase III – ELEVATE UC 52
88 Figure 18: Mirikizumab for Ulcerative Colitis (May 24, 2022): Phase III – LUCENT 2 (Maintenance)
90 Figure 19: CBP-307 for Ulcerative Colitis (May 3, 2022): Phase II – CBP-307CN002
92 Figure 20: GB004 for Ulcerative Colitis (April 25, 2022): Phase II – SHIFT-UC
97 Figure 21: Mirikizumab for Ulcerative Colitis (February 18, 2022): Phase III – LUCENT 1 (Induction)
99 Figure 22: Tremfya for Ulcerative Colitis (February 18, 2022): Phase IIb/III – QUASAR
101 Figure 23: Mirikizumab for Ulcerative Colitis (December 14, 2021): Phase III – LUCENT 2 (Maintenance)
103 Figure 24: BMS-986165 for Ulcerative Colitis (October 7, 2021): Phase II – LATTICE-UC
106 Figure 25: TD-1473 for Ulcerative Colitis (August 23, 2021): Phase IIb/III – RHEA
108 Figure 26: SER-287 for Ulcerative Colitis (July 22, 2021): Phase IIb – ECO-RESET
110 Figure 27: ABX464 for Ulcerative Colitis (May 24, 2021): Phase IIb – Multiple Dose (103)
112 Figure 28: Jyseleca for Ulcerative Colitis (March 4, 2021): Phase II – MANTA
113 Figure 29: Rinvoq for Ulcerative Colitis (February 22, 2021): Phase III – U-Accomplish
115 Figure 30: SHR0302 for Ulcerative Colitis (February 4, 2021): Phase II – AMBER2
116 Figure 31: AJM300 for Ulcerative Colitis (January 13, 2021): Phase III – AJM300/CT3 (Japan)
118 Figure 32: Omilancor for Ulcerative Colitis (January 4, 2021): Phase II – Mild to Moderate UC
120 Figure 33: Rinvoq for Ulcerative Colitis (December 9, 2020): Phase IIb/III – U-ACHIEVE
121 Figure 34: Key upcoming events in ulcerative colitis
LIST OF TABLES
12 Table 1: American College of Gastroenterology ulcerative colitis activity index
14 Table 2: 2019 ACG recommendations for induction of remission in patients with mildly active ulcerative colitis
15 Table 3: 2019 ACG recommendations for maintenance of remission in patients with previously mildly active ulcerative colitis
16 Table 4: 2019 ACG recommendations for induction of remission in patients with moderately to severely active ulcerative colitis
17 Table 5: 2019 ACG recommendations for maintenance of remission in patients with previously moderately to severely active ulcerative colitis
18 Table 6: 2019 ACG recommendations for hospitalized patients with acute severe ulcerative colitis
19 Table 7: 2021 ECCO treatment guidelines for mildly to moderately active ulcerative colitis
20 Table 8: 2021 ECCO treatment guidelines for maintenance of remission in mildly to moderately active ulcerative colitis
21 Table 9: 2021 ECCO treatment guidelines for induction of remission in moderately to severely active ulcerative colitis
22 Table 10: 2021 ECCO treatment guidelines for maintenance of remission of moderately to severely active ulcerative colitis
23 Table 11: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctitis
24 Table 12: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctosigmoiditis and left-sided ulcerative colitis
24 Table 13: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate extensive ulcerative colitis
25 Table 14: 2019 NICE treatment guidelines regarding biologics and JAK inhibitors for moderately to severely active ulcerative colitis for all extents of disease
26 Table 15: 2019 NICE treatment guidelines for acute severe ulcerative colitis for all extents of disease
27 Table 16: 2019 NICE treatment guidelines for maintaining remission
32 Table 17: Marketed drugs for ulcerative colitis
42 Table 18: Pipeline drugs for ulcerative colitis in the US
59 Table 1: Pipeline drugs for ulcerative colitis in the US
77 Table 20: Historical global sales, by drug ($m), 2017–21
80 Table 21: Forecasted global sales, by drug ($m), 2022–26
82 Table 22: AMT-101 for Ulcerative Colitis (July 6, 2022)
84 Table 23: IMU-838 for Ulcerative Colitis (June 2, 2022)
85 Table 24: Etrasimod for Ulcerative Colitis (May 24, 2022)
87 Table 25: Mirikizumab for Ulcerative Colitis (May 24, 2022)
89 Table 26: CBP-307 for Ulcerative Colitis (May 3, 2022)
90 Table 27: AMT-101 for Ulcerative Colitis (April 25, 2022)
91 Table 28: GB004 for Ulcerative Colitis (April 25, 2022)
93 Table 29: PN-943 for Ulcerative Colitis (April 25, 2022)
94 Table 30: Etrasimod for Ulcerative Colitis (March 29, 2022)
95 Table 31: Etrasimod for Ulcerative Colitis (March 23, 2022)
96 Table 32: Mirikizumab for Ulcerative Colitis (February 18, 2022)
98 Table 33: Tremfya for Ulcerative Colitis (February 18, 2022)
100 Table 34: Mirikizumab for Ulcerative Colitis (December 14, 2021)
102 Table 35: BMS-986165 for Ulcerative Colitis (October 7, 2021)
103 Table 36: Multiple Drugs for Ulcerative Colitis (September 1, 2021)
105 Table 37: TD-1473 for Ulcerative Colitis (August 23, 2021)
107 Table 38: SER-287 for Ulcerative Colitis (July 22, 2021)
108 Table 39: ABX464 for Ulcerative Colitis (May 24, 2021)
111 Table 40: Jyseleca for Ulcerative Colitis (March 4, 2021)
112 Table 41: Rinvoq for Ulcerative Colitis (February 22, 2021)
114 Table 42: SHR0302 for Ulcerative Colitis (February 4, 2021)
115 Table 43: AJM300 for Ulcerative Colitis (January 13, 2021)
117 Table 44: Omilancor for Ulcerative Colitis (January 4, 2021)
118 Table 45: Jyseleca for Ulcerative Colitis (December 15, 2020)
119 Table 46: Rinvoq for Ulcerative Colitis (December 9, 2020)
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