Ulcerative Colitis: KOL Insight
Ulcerative colitis (UC) treatment is on the brink. Patents are ending on various branded drugs and clearing the way for an influx of biosimilars; first-mover, Entyvio has a direct competitor coming on stream; and there is even talk of combination therapies and natural treatments in some quarters. What are the most influential key opinion leaders (KOLs) saying about market dynamics for UC drug therapies? How do they expect the market to flex and adapt? Are the new arrivals likely to face an enthusiastic welcome or more of a tepid reception?
Covering 5 marketed drugs and 9 pipeline therapies, this report gives the viewpoint from 12 KOLs in North America and Europe. Find out what they think about prescribing trends for different patient segments, the various products coming through the pipeline, and the key issues influencing treatment choices.
Take a tour of the report now:
- The table of contents
- The key questions answered
- The key KOL quotes
- See the 14 therapies covered
- Find out who the 12 EU & US KOLs are
- Review an extract from the report - 1 drug profile
- Uceris/Cortiment (budesonide MMX; Cosmo/Santarus/Ferring)
- Entyvio (vedolizumab; Takeda)
- Etrolizumab (RG 7413, rhuMab beta7; Roche)
- Stelara (ustekinumab; Johnson & Johnson)
- Plus 10 more – download the full list now
- Dr. Adam Cheifetz, MD, Director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School.
- Prof Jean-Frédéric Colombel, MD, Professor of Medicine and Director of the Susan and Leonor Feinstein IBD Center at Icahn School of Medicine in New York, NY.
- Prof Gerhard Rogler, MD, PhD, Professor of Gastroenterology and Hepatology and Ordinarius ad personam at the University of Zürich, based at the University hospital of Zurich.
- Prof Laurent Peyrin-Biroulet, MD, PhD, Department of HepatoGastroenterology, University Hospital of Nancy, Vandoeuvre-les-Nancy, France.
- Plus 8 more - download the full list now
- Possible change to mild-to-moderate UC treatment: What difference will LT 02 (controlled-release phosphatidylcholine) make to entrenched 5-ASA prescribing habits? Do KOLs see LT 02 as an alternative or an add-on for early stage patients?
- One brand is still the preferred TNF inhibitor, but for how long? How do gastroenterologists feel about switching to biosimilars and are they 100% confident about efficacy? Should originators be concerned for their market share?
- Patient education: Is patient perception that non-branded drugs are inferior a real problem or a perceived one? Do KOLs believe pharma is helping or hindering patient views on biosimilars? Could (and should) more be done to educate patients about treatment choices?
- Views on a crowded moderate-to-severe drug pipeline: One trial has recently halted but with 8 more still actively progressing, which hold most promise for KOLs? Conversely, which head-to-head trial is viewed as ‘risky’ and which current study is described as ‘completely uninteresting’?
- Two in-trial drugs are prompting more excitement than the rest: Which two potential new arrivals are viewed positively, but for different reasons? Could these be game changers for the severe patient segment?
- Safety and cost dominate the debate: KOLs express cynicism about various pipeline drugs and possible treatment pathways, primarily due to side effect profiles and cost. The latter may also impact appetite for combination therapies, even though many KOLs are calling for this.
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2. RESEARCH OBJECTIVES
3. RESEARCH FOCUS
4. MILD-TO-MODERATE ULCERATIVE COLITIS
4.1 Overview
4.2 Marketed drugs
4.3 Uceris/Cortiment (budesonide MMX; Cosmo/Salix /Ferring)
4.4 Pipeline drugs
4.5 LT-02 (phosphatidylcholine controlled-release;
4.6 Lipid Therapeutics/Dr Falk Pharma/Nestlé Health Science)
5. MODERATE-TO-SEVERE ULCERATIVE COLITIS
5.1 Overview
5.2 Marketed drugs
5.3 TNF inhibitors
5.4 Entyvio (vedolizumab; Takeda)
6. PIPELINE DRUGS
6.1 etrolizumab (RG7413, rhuMab beta7; Roche)
6.2 carotegrast methyl (AJM300; EA Pharma/Kissei)
6.3 Stelara (ustekinumab; Johnson & Johnson)
6.4 Xeljanz (tofacitinib, CP-690,550; Pfizer)
6.5 ozanimod (RPC 1063; Celgene)
6.6 GS-5745 (Gilead Sciences)
6.7 Kappaproct (cobitolimod, DIMS0150; InDex Pharmaceuticals)
6.8 alicaforsen (ISIS 2302; Atlantic Healthcare/Ionis Pharmaceuticals)
7. CURRENT AND FUTURE TREATMENT ALGORITHM
8. CONCLUSION
9. APPENDIX
9.1 KOL biographies
The goal of this FirstWord Therapy Trends report is to present a comprehensive qualitative review of drug therapies in the ulcerative colitis (UC) market with an emphasis on current and future treatment pathways. In order to achieve this goal, FirstWord analysts conduct detailed secondary research into current and late-stage pipeline therapies. This research focuses on the development of commercial and clinical profiles for each product, the identification of key clinical data, the isolation of key ongoing clinical trials, and the classification of the current treatment algorithm based on patient segment, line of therapy and patient characteristics.
Following this research, FirstWord conducts 60-minute telephone interviews with 12 key opinion leaders (KOLs) from across the major markets to provide expert views on the current treatment landscape and how it will change in the future.
In order to ensure the quality of the interviews, the KOLs are carefully selected based on their clinical experience, authored scientific publications, involvement in clinical trials and within the Pharma industry, their participation in treatment guideline development, and their record of presenting at high-profile international conferences. Moderators with detailed knowledge of the market dynamics and a track record of obtaining valuable insights from the KOLs conduct the interviews with the following objectives:
- Which therapies are the treatment of choice for each patient segment, line of therapy and unique patient characteristic, and what product attributes contribute to this preference e.g. based on efficacy, safety, ease of administration?
- How is the product perceived by the medical community in terms of efficacy, tolerability, ease of administration and other product attributes, and how does it compare with other treatment options?
- Which recently completed or ongoing clinical trials have the greatest potential to impact prescribing trends and how will the results impact future practice e.g. Simponi paediatric trial and etrolizumab’s head-to-head trials versus TNF inhibitors?
- What will therapies need to show in order to become the treatment of choice in a specific line of therapy and is it likely the products will meet these requirements?
- How will the use of each current and pipeline drug change in the future in terms of line of therapy and preference e.g. Takeda/Millennium’s Entyvio (vedolizumab) and Pfizer’s tofacitinib?
- What will the pipeline products for UC need to show in terms of efficacy and tolerability endpoints to effectively compete with current therapies, and what is the likelihood the pipeline products will achieve those endpoints?
- Which pipeline products are the most promising and how will they impact current players in the market e.g. etrolizumab (Genentech) and LT 02 (Lipid Therapeutics/Dr Falk Pharma)?
- How will the treatment landscape for UC evolve in the future for each patient segment and line of therapy?
The insights obtained from both the primary and secondary research are organised by disease activity (mild-to-moderate and moderate-to-severe) as well as by marketed and pipeline products. The insights begin with a concise overview, followed by more detailed insights focussed on each current and pipeline product. At the end of the report, the current and future treatment algorithm for UC is summarised, allowing rapid identification of key players and expected future developments.
