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The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Psoriasis– January 13, 2020

January 13, 2020

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Presentation of full data from P3 BE SURE trial (NCT03412747) for psoriasis at ESDR (September 02-September 05, 2020) (J.P. Morgan) – Jan 9, 2020 – A subscription to Thomson ONE is required to gain full access to report 68594462; Page no: 129; REPORT TITLE: “EU Pharma & Biotech: Sector set to top the medal table in an Olympic year”; AUTHOR: Vosser, Richard, et al; DATE: 1/06/2020

 

Cosentyx (secukinumab) / Novartis
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site (clinicaltrials.gov) – Jan 9, 2020 – P3; N=204; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed

 

Qletli (adalimumab biosimilar) / Bio-Thera Solutions
Bio-Thera Solutions launches first commercial product, Qletli (格乐立), in China (Businesswire) – Jan 10, 2020 – “Bio-Thera Solutions, Ltd…today announced that QLETLI® (格乐立®), a biosimilar to Humira® (adalimumab), is now available in China. QLETLI® (格乐立®), the first adalimumab biosimilar approved by the China National Medical Products Administration (NMPA), is authorized for the treatment of three autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.35B by 2020 (GlobalData) – Jan 7, 2020 – A subscription to Thomson ONE is required to gain full access to report 67598474 Page no: 66; REPORT TITLE: ” Cipher Pharmaceuticals Inc (CPH) – Financial analysis review”; AUTHOR: GlobalData ; DATE: 12/30/2019

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Weekly Top News – Breast Cancer– January 6, 2020

January 6, 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu now available in U.S. for HER2 positive unresectable or metastatic breast cancer following two or more prior anti-HER2-based regimens (Businesswire) – Jan 6, 2020 – “Daiichi Sankyo Company, Limited…announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S….ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.”

 

Tuoyi (toripalimab) / Shanghai Junshi Bioscience
Junshi Bio and CSPC Pharma disengage from Tuoyi/paclitaxel deal (GBI Health) – Dec 31, 2019 – “China-based CSPC Pharmaceutical Group Ltd (1093.HK) and Shanghai Junshi Biosciences Co Ltd have agreed to terminate a deal struck in June 2018 in relation to programmed death-1 (PD-1) monoclonal antibody (mAb) Tuoyi (toripalimab) combined with paclitaxel in treating breast cancer. The firms cite a ‘potential conflict of interests in terms of CSPC Pharma’s PD-1 mAb development’ as the reason for the cancellation…Per the termination agreement, the milestone payments and RMB 3.68 million (527,000) in clinical development expenses paid to Junshi Bio will not be refunded, and no further milestone payments will be made.”

 

Faslodex (fulvestrant) / AstraZeneca; AZD9833 / AstraZeneca
SERENA-2: A Comparative Study of AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer (clinicaltrials.gov) – Jan 2, 2020 – P2; N=288; Not yet recruiting; Sponsor: AstraZeneca

 

Imfinzi (durvalumab) / AstraZeneca, BMS
Imfinzi sales projection: $4.8B in 2025 (Cowen & Co) – Jan 3, 2020 – A subscription to Thomson ONE is required to gain full access to report 68527170; Page no: 7; REPORT TITLE: “Portfolio manager’s weekly – December 20, 2019”; AUTHOR: Cowen Research, et al; DATE: 12/20/2019

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Weekly Top News – IBD– January 6, 2020

January 6, 2020

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

 

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 – Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis at year end 2021

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
MAPUS: Efficacy and Safety of Anti-MAP Therapy in Adult Crohn’s Disease (clinicaltrials.gov) – Jan 2, 2020 – P3; N=331; Completed; Sponsor: RedHill Biopharma Limited; Active, not recruiting –> Completed; Trial completion date: Apr 2019 –> Aug 2019

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: January 2024 in EU (Barclays) – Jan 2, 2020 – A subscription to Thomson ONE is required to gain full access to report 68519497; Page no: 8; REPORT TITLE: “Johnson & Johnson: Last minute gift idea? JNJ; Upgrade to overweight”; AUTHOR: Stewart, Kristen, et al; DATE: 12/19/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Xifaxan patent protection: Until 2031 for soluble solid dispersion tablets (Guggenheim) – Dec 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502576; Page no: 4; REPORT TITLE: “Bausch Health Companies Ltd- BHC (Buy) – Hepatic encephalopathy (HE) deep dive ahead of phase 2 data”; AUTHOR: Research Department; DATE: 12/16/2019

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Simponi patent expiry: April 2025 in EU and February 2024 in US (Barclays) – Jan 2, 2020 – A subscription to Thomson ONE is required to gain full access to report 68519497; Page no: 8; REPORT TITLE: “Johnson & Johnson: Last minute gift idea? JNJ; Upgrade to overweight”; AUTHOR: Stewart, Kristen, et al; DATE: 12/19/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib WW sales projection: $6.7B in 2030 (Morgan Stanley) – Jan 3, 2020 – A subscription to Thomson ONE is required to gain full access to report 68506973; Page no: 207; REPORT TITLE: “Biotechnology: 2020 outlook: Still a stockpickers’ world, but macro pressures receding”; AUTHOR: Harrison, Matthew, et al; DATE: 12/17/2019

 

Humira (adalimumab) / Eisai, AbbVie
Pfizer, AbbVie and Gilead among drugmakers boosting prices to start 2020 (BioPharma Dive) – Jan 2, 2020 – “Some of the largest pharmaceutical and biotech companies started 2020 by increasing U.S. list prices for a range of top-selling medications, despite intense political scrutiny on the industry and its pricing practices…AbbVie raised the list price of Humira (adalimumab), the world’s best-selling drug, by 7.4%, according to Raymond.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Xifaxan patent protection: Until 2027 (Cowen & Co) – Dec 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68468883; Page no: 1; REPORT TITLE: “Bausch Health Companies Ltd- Best ideas for 2020: Continued execution should generate significant value”; AUTHOR: Cacciatore, Ken,et al; DATE: 12/09/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Xifaxan sales projection: $2.3B by 2028 (Guggenheim) – Dec 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502576; Page no: 2; REPORT TITLE: “Bausch Health Companies Ltd- BHC (Buy) – Hepatic encephalopathy (HE) deep dive ahead of phase 2 data”; AUTHOR: Research Department; DATE: 12/16/2019

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Weekly Top News – Psoriasis– January 6, 2020

January 6, 2020

Stelara (ustekinumab) / J&J
Stelara patent expiry: January 2024 in EU (Barclays) – Jan 2, 2020 – A subscription to Thomson ONE is required to gain full access to report 68519497; Page no: 8; REPORT TITLE: “Johnson & Johnson: Last minute gift idea? JNJ; Upgrade to overweight”; AUTHOR: Stewart, Kristen, et al; DATE: 12/19/2019

 

AVT02 (adalimumab biosimilar) / Alvotech, Cipla; Humira (adalimumab) / Eisai, AbbVie
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jan 3, 2020 – P3; N=413; Active, not recruiting; Sponsor: Alvotech Swiss AG; Recruiting –> Active, not recruiting; Initiation date: Feb 2019 –> Dec 2019

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