Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of ulcerative colitis (UC). Topics covered include expert opinions on; Protagonist Therapeutics announcing the initiation of a global Phase IIb induction study in UC with PTG 100, an oral peptide that targets alpha4beta7 integrin; Atlantic Healthcare announcing that it has received agreement from the FDA to initiate a rolling submission of its New Drug Application (NDA) for alicaforsen to treat pouchitis; as well as Cellceutix announcing the progression of its ongoing Phase II trial of brilacidin, a new class of antibiotic, to the third cohort (highest dose) for induction of remission of mild-to-moderate UC.*Latest* Update 2: March 2017
Update 1: Dec 2016
Original Publication: Seot 2016
*Purchase of this report includes all updates*
This update tackles these key questions
- How do KOLs view PTG 100 as a therapy for UC?
- Do experts have any specific concerns regarding PTG 100?
- According to KOLs, how clinically attractive is alicaforsen in pouchitis and UC?
- What are KOLs’ opinions on brilacidin’s mechanism of action?
- Where in the treatment paradigm could brilacidin be positioned?
Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of ulcerative colitis (UC). Topics covered include expert opinions on: Galapagos obtaining US and EU regulatory approval to commence Phase III trials for its JAK1 inhibitor, filgotinib, in patients with UC and Crohn’s disease; the US Food & Drug Administration (FDA) approving Amgen’s Amjevita (adalimumab-atto), a biosimilar of Humira (adalimumab; AbbVie), for multiple inflammatory diseases, including Crohn's disease and UC; and TopiVert announcing that the first patients have been dosed in its Phase IIa proof-of-concept study to evaluate the safety, tolerability and efficacy of a rectal formulation of TOP1288, a narrow spectrum kinase inhibitor, in symptomatic UC patients with moderate-to-severe disease activity.
Original Publication: Are UC biosimilars a real or perceived threat to branded drugs?
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.
“Fundamentally biosimilars are going to be a good thing, because it's going to drive costs down. There might be some minor differences clinically, but improving access of these drugs to the population far outweighs any clinical downside or scientific downside.”
US Key Opinion Leader
Take a tour of the report now:
Sample of brands covered:
- 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 >
Sample of KOLS interviewed
- 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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Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.
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