Weekly Top News – IBD– January 13, 2020

January 13, 2020

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis at year end 2021 (SVB Leerink) – Jan 6, 2020 – A subscription to Thomson ONE is required to gain full access to report 68502627; Page no: 72; REPORT TITLE: “2020 outlook for investing in healthcare”; AUTHOR: Sullivan, John, et al; DATE: 12/16/2019


etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P2b/3 CULTIVATE trial (NCT04173273) for Crohn’s disease in H2 2021 (SVB Leerink) – Jan 6, 2020 – A subscription to Thomson ONE is required to gain full access to report 68502627; Page no: 72; REPORT TITLE: “2020 outlook for investing in healthcare”; AUTHOR: Sullivan, John, et al; DATE: 12/16/2019


Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; brazikumab (AMG 139) / Allergan
Mergers: Commission approves AbbVie’s acquisition of Allergan, subject to conditions (European Commission) – Jan 10, 2020 – “The European Commission has approved, under the EU Merger Regulation, the proposed acquisition of Allergan by AbbVie. The approval is conditional on the divestment of a product under development by Allergan to treat inflammatory bowel diseases….The Commission found that brazikumab is likely to compete closely with AbbVie’s risankizumab…To address the Commission’s competition concerns, AbbVie offered to divest brazikumab…including the development, manufacturing and marketing rights at worldwide level, to a purchaser that will continue the drug’s development.”


etrolizumab (RG7413) / Roche
HIBISCUS I: A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1) (clinicaltrials.gov) – Jan 6, 2020 – P3; N=351; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting –> Active, not recruiting


Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Belgium’s UCB raises 2019 forecasts after net sales beat in Q4 (Reuters) – Jan 10, 2020 – “Belgian drugmaker UCB raised its revenue and earnings per share guidance for 2019 on Friday, helped by better-than-expected net sales due to strong demand for its Cimzia…drugs in the fourth quarter. Full-year revenue is expected now at about 4.9 billion euros, above the previously expected range of 4.6–4.7 billion euros…it said in a statement.”


Humira (adalimumab) / Eisai, AbbVie
Why Humira’s price keeps rising despite FDA approval of generic competition (The Washington Post) – Jan 8, 2020 – “The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023….In a statement, it chose to focus on its ‘net price,’ the amount paid by insurance companies. ‘This is an increase in list price and represents a net price increase that is in line with the projected rate of inflation,’ the company said.”


Humira (adalimumab) / Eisai, AbbVie
In brief: Appeals court chips away at Abbvie’s Humira patent fortress (Reuters) – Jan 8, 2020 – “A federal appeals court on Tuesday upheld a ruling that invalidated some of Abbvie Inc’s patents on Humira…Affirming the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit said three Abbvie patents on Humira were invalid as obvious.”


foralumab (TZLS-401) / Tiziana Life Sciences
Tiziana reports phase 1 clinical data demonstrating oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, is well-tolerated in healthy volunteers (Businesswire) – Jan 9, 2020 – “Tiziana Life Sciences plc…is pleased to report completion of a Phase 1 clinical study of Foralumab…in healthy subjects. The proprietary oral formulation…was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial….All subjects completed the trial without any safety concerns at any of the doses.”


PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics achieves milestone in Janssen Biotech, Inc., collaboration (PRNewswire) – Jan 7, 2020 – “Protagonist Therapeutics, Inc….today announced the achievement of a research milestone under its worldwide license and research collaboration agreement with Janssen Biotech, Inc….for co-development activities with affiliate Janssen Research & Development, LLC, and commercialization of…PTG-200 (JNJ-67864238) and second generation peptides for all indications including inflammatory bowel disease (IBD).”


vidofludimus (IMU-838) / Immunic
CALDOSE-1: Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (clinicaltrials.gov) – Jan 9, 2020 – P2; N=240; Recruiting; Sponsor: Immunic AG; N=150 –> 240; Trial completion date: Dec 2027 –> Jun 2029; Trial primary completion date: Jan 2021 –> Jul 2022

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