Weekly Top News – IBD– December 16, 2019

December 16, 2019
Inflammatory Bowel Disease

Xeljanz XR (tofacitinib XR) / PfizerFDA approves Xeljanz XR (tofacitinib) extended-release tablets for the treatment of ulcerative colitis (Pfizer Press Release) - Dec 12, 2019 - "Pfizer Inc...announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers."TD-1473 / J&JTD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) - Dec 11, 2019 - P2/3; N=500; Not yet recruiting; Sponsor: Theravance Biopharma; Initiation date: Nov 2019 --> Feb 2020Remicade (infliximab) / Mitsubishi Tanabe, J&JADAPT: An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease (clinicaltrials.gov) - Dec 9, 2019 - P4; N=55; Terminated; Sponsor: Janssen Scientific Affairs, LLC; Completed --> Terminated; Study was terminated due to the inability to enroll a sufficient number of the required subject populationNI-071 (infliximab biosimilar) / Sanofi, Nichi-Iko, Binex, AprogenKorea's 11th unicorn company 'Aprogen' is the only biotechnology company [Google Translation] (Sisaweek) - Dec 10, 2019 - "...the company has successfully developed 'GS071' (Japan NI071), a biosimilar that is used to treat autoimmune diseases such as rheumatoid arthritis and Crohn's disease...Aprogen plans to apply for the GS071 in the US next year and obtain a US product approval in 2021."Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimSkyrizi US sales projection: $178M in Q4 2019 (UBS) - Dec 11, 2019 - A subscription to Thomson ONE is required to gain full access to report 68424496; Page no: 1; REPORT TITLE: "US Pharmaceuticals "Drug launches – weekly tracker" Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/29/2019ozanimod (RPC1063) / BMSOzanimod sales projection: Consensus of $1B in 2022 (William O Neil) - Dec 10, 2019 - A subscription to Thomson ONE is required to gain full access to report 68456923; Page no: 5; REPORT TITLE: "WON Global view -- December 6, 2019”; AUTHOR: Research Department; DATE: 12/06/2019Rinvoq (upadacitinib) / AbbVieRinvoq WW sales projection: $530M in 2020, $1,004M in 2021 and $1,963M in 2022 (Piper Jaffray) - Dec 11, 2019 - A subscription to Thomson ONE is required to gain full access to report 68437953; Page no: 1; REPORT TITLE: "Abbvie Inc - New rheumatologist survey indicates Rinvoq is trending ahead of expectations”; AUTHOR: Raymond, Christopher, et al; DATE: 12/03/2019Remicade (infliximab) / Mitsubishi Tanabe, J&JAlberta will force patients to switch from biologics to cheaper biosimilar medications (The Globe and Mail) - Dec 12, 2019 - "Alberta will force 26,000 patients on government-sponsored drug plans to switch from expensive drugs that are known as biologics to cheaper near-copies of the medications, a move that will save the province hundreds of millions of dollars in the coming years...Alberta’s plan will require existing patients on government-sponsored drug plans to switch to the biosimilar versions of Remicade....The changes, which kick in July 1, 2020, do not apply to patients with private insurance or patients who pay out of pocket for their prescription drugs."Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimA Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment (clinicaltrials.gov) - Dec 9, 2019 - P3; N=579; Recruiting; Sponsor: AbbVie; Trial completion date: Jun 2020 --> Mar 2021; Trial primary completion date: Jun 2020 --> Mar 2021