Summary "Competitor Landscape: Inflammatory Bowel Disease (IBD)", briefings contain evaluations of ongoing development activities within the Inflammatory Bowel Disease (IBD) market, together with analysis of current & potential future product positioning.
Key Highlights from the report - - Given the significant time difference between primary completion dates of VISIBLE 1 (UC) and VISIBLE 2 (Crohn’s disease), Takeda will likely file the subQ formulation of VDZ in UC before filing in Crohn’s disease, in order to mitigate against the risk of ustekinumab becoming established in UC. - RHB-104 will likely be the first antibiotic approved in Crohn’s disease, but RedHill BioPharma announced in the results webcast that it will likely need to conduct an additional Phase III trial to support a New Drug Application (NDA) in the US, which will delay its approval timeline. - Allergan is the second company, after Genentech (with UTTR1147A), to use vedolizumab as an active comparator in a Phase II UC trial, with the design suggesting brazikumab could proceed directly to Phase III if it is successful at Phase II.
The report comprises four key sections.
Executive Summary: Contains analysis of key market events that have occurred during the previous month and which have impacted the Inflammatory Bowel Disease (IBD) landscape
Pipeline Landscape: Section contains the following analysis - - ‘Order of Entry’ analysis, detailing timeline forecasts for each drug in Phase II development or later. - An overview of pipeline candidates, containing snapshots of current development status. - Expected drug-specific events & milestones until YE 2019. - Assessment of initial market entry strategies for key pipeline candidates.
Approved Product Landscape: Section contains the following analysis - - An overview of marketed candidates, containing snapshots of current development status. - Timeline forecasts for each approved product’s lifecycle management initiatives. - Expected drug-specific events & milestones until YE 2018. - ‘Direction of Travel’ positioning analysis for currently approved therapies.
Appendix: Data slides containing the following information - - Current Early Stage IBD Pipeline & candidate ‘Watch List’. - Timeline Assumptions, including standard assumptions & drug-specific assumptions.
Scope - The briefing is based on Sociable Pharma’s analysis of clinical trial data from company announcements (press releases, earnings calls) and clinical trial databases (clinicaltrials.gov) - Sociable Pharma applies disease & drug specific assumptions in order to forecast US & EU approvals for drugs in Phase II development, or higher - these are outlined in the report Appendix - Forecasts are presented in pipeline forecast figures & detailed tables - ‘Market Entry’ & ‘Direction of Travel’ positioning analysis for pipeline & currently approved therapies is also provided.
Reasons to buy - Provides details on forecast US & EU approvals for pipeline drugs in Phase II development or higher - Includes potential positioning strategies that companies may adopt for their novel assets once they are approved & launched in the market - Reviews ongoing lifecycle management strategies for existing players in the market - A detailed methodology allows you to understand the forecast assumptions made, enabling cross comparison with your own internal forecasts.
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