Weekly Top News – IBD – September 9, 2019

September 9, 2019

Stelara (ustekinumab) / J&J
European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union (Businesswire) – Sep 4, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies….The EC approval is based on data from the pivotal Phase 3 UNIFI trial programme…”


Otezla (apremilast) / Amgen
Otezla patent expiry: February 2028 (CFRA) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67874668; Page no: 5; REPORT TITLE: “Amgen Inc”; AUTHOR: Huang, Kevin, et al; DATE: 08/26/2019


Entyvio SC (vedolizumab SC) / Takeda; Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer; Entyvio (vedolizumab) / Takeda; Humira (adalimumab) / Eisai, AbbVie; Stelara (ustekinumab) / J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J; Xeljanz (tofacitinib) / Pfizer; Remicade (infliximab) / Mitsubishi Tanabe, J&J
ICER to assess treatments for ulcerative colitis (Institute for Clinical and Economic Review) – Sep 6, 2019 – “The Institute for Clinical and Economic Review (ICER) announced today that it plans to assess the comparative clinical effectiveness and value of therapies for ulcerative colitis (UC), including: Vedolizumab (Entyvio®, Takeda), subcutaneous and IV formulations, Infliximab (Remicade®, Janssen), Infliximab-dyyb (Inflectra®, Pfizer), Adalimumab (Humira®, AbbVie), Golimumab (Simponi®, Janssen), Tofacitinib (Xeljanz®, Ustekinumab (Stelara®, Janssen)….A draft scoping document, which will provide more detail on ICER’s planned analysis, will be available on September 27, 2019. That document will be open to public comment for three weeks.”


Otezla (apremilast) / Amgen
Otezla WW sales projection: $3.1B (US: $2.5B) peak in 2028 (RBC Capital Markets (Canada)) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873985; Page no: 3; REPORT TITLE: “Amgen Inc. – Thesis-changing M&A comes at a high cost: Otezla acquisition adds +$14/sh to PT”; AUTHOR: Mackay, Kennen, et al; DATE: 08/26/2019


Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi WW sales projection: $300M in FY2019 and $800M in FY2020 (Piper Jaffray) – Sep 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67909429; Page no: 1; REPORT TITLE: “Abbvie Inc – Skyrizi En Fuego – New derm survey indicates Q219 was no fluke”; AUTHOR: Raymond, Christopher, et al; DATE: 09/04/2019

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