Weekly Top News – IBD – February 3, 2020

February 3, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission in US for ulcerative colitis in 2020 (Roche) – Jan 30, 2020 – FY 2019 Results: Regulatory submission in EU for ulcerative colitis in 2020 


Stelara (ustekinumab) / J&J
REScUE: Loss of RESponse to Ustekinumab Treated by Dose Escalation (clinicaltrials.gov) – Jan 28, 2020 – P3; N=108; Not yet recruiting; Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW


Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The CHMP adopted an opinion by consensus based on the PRAC recommendation [Ulcerative colitis]” (EMEA) – Jan 28, 2020 – CHMP Final Minutes for the meeting on 11-14 November 2019: “The Committee recommended that the marketing authorisations for Xeljanz should be varied. It was recommended that Xeljanz should be used with caution in all patients at high risk of blood clots”


Stelara (ustekinumab) / J&J
Health Canada approves new indication for Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (Canada Newswire) – Jan 27, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial…”


brazikumab (AMG 139) / Allergan
Abbvie and Allergan announce agreements to divest brazikumab and Zenpep (Allergan Press Release) – Jan 27, 2020 – “AbbVie…today announced that Allergan has entered into definitive agreements to divest brazikumab (IL-23 inhibitor)…AstraZeneca…will acquire brazikumab…in Phase 2b/3 development for Crohn’s Disease and in Phase 2 development for ulcerative colitis, including global development and commercial rights….AbbVie and Allergan continue to expect a first-quarter 2020 close of their pending transaction, subject to receipt of required regulatory approvals and other closing conditions.”


Humira (adalimumab) / Eisai, AbbVie
Humira sales projection: $20B peak (Credit Suisse) – Jan 29, 2020 – A subscription to Thomson ONE is required to gain full access to report 68679165; Page no: 22; REPORT TITLE: – “First edition summary Europe: Monday, 20 January, 2020”; AUTHOR: Product Marketing, Credit Suisse E, et al; DATE: 01/20/2020


filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $517M for Crohn’s disease by 2030 (Morgan Stanley) – Jan 30, 2020 – A subscription to Thomson ONE is required to gain full access to report 68667865; Page no: 129; REPORT TITLE: – “Biotechnology: Quick 4Q19 preview”; AUTHOR: Harrison, Matthew, et al; DATE: 01/17/2020


Alofisel (darvadstrocel) / Takeda
Alofisel sales projection: $250M in 2024 (Bank Vontobel) – Jan 28, 2020 – A subscription to Thomson ONE is required to gain full access to report 68642122; Page no: 15; REPORT TITLE: – “Lonza (BUY, PT CHF 390) – An in-depth look into Lonza’s biologics businesses – the pearl and main growth driver of Lonza going forward”; AUTHOR: Buchta, Daniel, et al; DATE: 01/14/2020


phosphatidylcholine CR (LT‑02) / Lipid Therap, Nestle, Dr Falk
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) (clinicaltrials.gov) – Jan 27, 2020 – P3; N=150; Completed; Sponsor: Dr. Falk Pharma GmbH; Active, not recruiting –> Completed


The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata (clinicaltrials.gov) – Jan 27, 2020 – P; N=4000; Not yet recruiting; Sponsor: Momentum Data

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