Weekly Top News – IBD – November 25, 2019

November 25, 2019

Humira (adalimumab) / Eisai, AbbVie
Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Nov 22, 2019 – P3; N=952; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed


Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan clinical trial estimate: Interim data from P2 trial (NCT03515044) for overt hepatic encephalopathy in Q4 2019 (Cowen & Co) – Nov 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 68320235; Page no: 2; REPORT TITLE: “Bausch Health Companies Inc- Model update: Thesis unchanged – Reiterate (1)”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/11/2019


PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Data from P2 trial for Crohn’s disease in H1 2021 (Stifel 2019 Healthcare Conference, Protagonist Therapeutics) – Nov 21, 2019 


Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The Committee discussed the issues identified in this application, mainly concerning the clinical efficacy data and the feasibility of a registry analyses [extension application to introduce a new pharmaceutical form (prolonged-release tablet) associated with a new strength (11 mg)]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The Committee adopted the CHMP recommendation and scientific discussion together with a 3rd list of outstanding issues and a specific timetable.”


etrasimod (APD334) / Arena
CULTIVATE: A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Nov 21, 2019 – P2b; N=225; Not yet recruiting; Sponsor: Arena Pharmaceuticals


filgotinib (GLPG0634) / Gilead
Filgotinib pricing projection: $50,00/year (SunTrust) – Nov 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 68321433; Page no: 59; REPORT TITLE: “Gilead Sciences Inc.-Initiating coverage – Initiating at Hold and $70 PT; HIV deep-dive on patent cliffs & PrEP”; AUTHOR: Research Department; DATE: 11/11/2019


Remicade (infliximab) / Mitsubishi Tanabe, J&J
Doctor urges Alberta not to switch coverage to cheaper meds for patients with IBD (Yahoo News) – Nov 21, 2019 – “Alberta is looking to switch to covering a cheaper alternative medication for patients with inflammatory bowel disease (IBD) — a move an expert says could harm some patients’ health…The minister’s office said in the past decade, the province’s spending on biologics has increased from around $20 million per year to more than $200 million…But the maker of Remicade, one of the biologics for Crohn’s patients that would be impacted, said it has reached out to the government to offer its product at a cost comparable to biosimilars.”


Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Patent delisted for Xifaxan from Orange Book (Orange Book) – Nov 20, 2019 – Patent no. 10314828 

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