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Pharma news roundup and Larvol updates

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Category: Inflammatory Bowel Disease

Weekly Top News – IBD – November 11, 2019

November 11, 2019

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Initiation of P2/3 trial for Crohn’s disease in H1 2020 (Bausch Health) – Nov 5, 2019 – Q3 2019 Results 
[Screenshot]

 

amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Amiselimod: Initiation of P2 trial for ulcerative colitis in H1 2020 (Bausch Health) – Nov 5, 2019 – Q3 2019 Reuslts 
[Screenshot]

 

PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics announces first patient dosed in a phase 2 study of oral IL-23 receptor antagonist PTG-200 (JNJ-67864238) in the treatment of Crohn’s disease (PRNewswire) – Nov 6, 2019 – P2, N=90; PRISM (NCT04102111); Sponsor: Janssen Research & Development, LLC; “Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first patient has been dosed in a Phase 2 study of PTG-200 (also referenced as JNJ-67864238) in patients with moderate to severe Crohn’s disease…The global, randomized, double blind, placebo-controlled, Phase 2 study is evaluating the efficacy of oral administration of PTG-200 in 90 patients with moderate to severe Crohn’s disease…Clinical efficacy results for the Janssen Collaboration Asset are expected in 2021.”

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $5.9B peak for rheumatoid arthritis, $2.6B for ankylosing spondylitis, $1.1B for ulcerative colitis, $870M for psoriatic arthritis and $790M in Crohn’s disease by 2030 (Morgan Stanley) – Nov 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68200745; Page no: 3; REPORT TITLE: “Galapagos NV: MOR106 Stopped for futility.”; AUTHOR: Harrison, Matthew, et al; DATE: 10/28/2019

 

etrolizumab (RG7413) / Roche
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 #2) (clinicaltrials.gov) – Nov 10, 2019 – P3; N=350; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Dec 2020 –> Jul 2020; Trial primary completion date: Oct 2020 –> Mar 2020

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $275M in 2020 (Wolfe Research) – Nov 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68243153; Page no: 2; REPORT TITLE: “Abbvie Inc Global Pharmaceuticals – ABBV: 3Q19 – They just said what?! Highlights from conference call that just ended”; AUTHOR: Anderson, Tim, et al; DATE: 11/01/2019

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $3.1B in FY2019 (Cowen & Co) – Nov 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68241376; Page no: 19; REPORT TITLE: “Takeda Pharaceutical Co Ltd- Initiating coverage: Initiation: management is executing but pressures on key franchises outweigh”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/01/2019

 

Rinvoq (upadacitinib) / AbbVie
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy (clinicaltrials.gov) – Nov 4, 2019 – P3; N=645; Recruiting; Sponsor: AbbVie; Trial completion date: Feb 2021 –> Jun 2021; Trial primary completion date: Feb 2021 –> Jun 2021

 

Xeljanz (tofacitinib) / Pfizer
Health puts restrictions on Xeljanz (Pfizer) for risk of thromboembolism [Google Translation] (Redacción Médica) – Nov 6, 2019 – “The Agency for Medicines and Health Products ( Aemps ) has announced new restrictions on the use of Xeljanz, Pfizer medication with tofacitinib as an active ingredient that is indicated for various inflammatory diseases such as arthritis. This decision of the Aemps is motivated after the review carried out by the Committee for Risk Assessment in European Pharmacovigilance (PRAC ) on this drug.”

 

READ-UC: Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal (clinicaltrials.gov) – Nov 7, 2019 – P; N=310; Not yet recruiting; Sponsor: Pfizer

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Weekly Top News – IBD – November 4, 2019

November 4, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib launch estimate: 2021 for ulcerative colitis and Crohn’s disease (Credit Suisse) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183641; Page no: 31; REPORT TITLE: “First edition – US Alert: Friday, October 25, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 10/25/2019

 

Xeljanz (tofacitinib) / Pfizer
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019 (EMEA) – Oct 31, 2019 – “The PRAC concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. The PRAC recommended that Xeljanz should be used with caution in patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk…Patients older than 65 years of age should be treated with Xeljanz only when there is no other appropriate treatment.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib US sales projection: $35M in 2021, $80M in 2022, $165M in 2023 and $300M in 2024 to Gilead (Cowen & Co) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68178826; Page no: 4; REPORT TITLE: “Gilead Sciences Inc – Q3 In-line, guidance narrowed; Boring is ok, though it won’t drive a re-rating”; AUTHOR: Nadeau, Phil, et al; DATE: 10/24/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan patent expiry: 2024/2025 related to composition-of-matter (Cowen & Co) – Nov 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183642; Page no: 30; REPORT TITLE: “Bausch Health Companies Inc – Initiating Coverage Initiation: Transformed & diversified, Bausch Health should slowly grind higher”; AUTHOR: Cacciatore, Ken, et al; DATE: 10/25/2019

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: July 2024 in EU (Kepler Cheuvreux) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68195721; Page no: 1; REPORT TITLE: “Formycon AG Espresso Note | Formycon | Buy | start of phase I for FYB202”; AUTHOR: Choplain, Damien, et al; DATE: 10/28/2019

 

etrolizumab (RG7413) / Roche
Open-Label Extension and Safety Study for Patients With Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (clinicaltrials.gov) – Oct 31, 2019 – P3; N=900; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Apr 2024 –> Oct 2025; Trial primary completion date: Apr 2024 –> Oct 2025

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma to present new phase 3 data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting (GlobeNewswire) – Oct 28, 2019 – “RedHill Biopharma Ltd…announced that two oral presentations and two posters on two of the Company’s leading drug candidates, RHB-1051 (Talicia®, H. pylori infection) and RHB-104 (Crohn’s disease) will be presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting, being held October 25-30, in San Antonio, Texas.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan US patent expiry: July 2029 (Cowen & Co) – Nov 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183642; Page no: 31; REPORT TITLE: “Bausch Health Companies Inc – Initiating Coverage Initiation: Transformed & diversified, Bausch Health should slowly grind higher”; AUTHOR: Cacciatore, Ken, et al; DATE: 10/25/2019

 

Rinvoq (upadacitinib) / AbbVie
A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies (clinicaltrials.gov) – Oct 30, 2019 – P3; N=501; Recruiting; Sponsor: AbbVie; Trial completion date: Mar 2022 –> Sep 2021; Trial primary completion date: Mar 2022 –> Sep 2021

 

Entyvio SC (vedolizumab SC) / Takeda
Douglas Wolf, MD: Vedolizumab subcutaneous treatment for ulcerative colitis (MD Magazine) – Nov 3, 2019 – “The biological license application to the FDA has already been submitted and things are in the works for approval of subcutaneous ENTYVIO. That approval is anticipated in in 2020. It may be early in 2020, it may be in the middle of 2020, it’s not absolutely unknown.”

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Weekly Top News – IBD – October 28, 2019

October 28, 2019

Stelara (ustekinumab) / J&J
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (PRNewswire) – Oct 21, 2019 – “The Janssen Pharmaceutical Companies…announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Gilead) – Oct 25, 2019 – Q3 2019 Results 
[Screenshot]

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Initiation of P2b/3 CULTIVATE trial for Crohn’s disease in Q4 2019 (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68024735; Page no: 3; REPORT TITLE: “Companies, catalysts and controversies: Top questions for management at our upcoming global healthcare conference”; AUTHOR: Research Department; DATE: 09/29/2019

 

Stelara (ustekinumab) / J&J
Stelara (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial (Businesswire) – Oct 21, 2019 – P3, N=399; UNIFI (NCT02407236); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies…announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented today as a late-breaking data presentation (LB01) at the 27th UEGW congress…Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission…Results from the UNITI Crohn’s disease (CD) clinical trial programme are also being presented at the congress.”

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals presented new data analyses demonstrating the long-term safety and efficacy of once-daily etrasimod in patients with moderately to severely active ulcerative colitis at UEG Week (PRNewswire) – Oct 22, 2019 – P2, N=156; OASIS (NCT02447302); Sponsor: Arena Pharmaceuticals; “Arena Pharmaceuticals, Inc…resented new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod…in patients with moderately to severely active ulcerative colitis (UC) at the 25th Annual United European Gastroenterology (UEG) Week…’We are delighted to see that most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46….Etrasimod also demonstrated a favorable safety profile, consistent with safety findings reported in the double-blind portion of OASIS,'”

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 VIVID-1 trial (NCT03926130) for Crohn’s disease in Feb 2022 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 VIVID-1 trial for Crohn’s disease in Jul 2023; Completion of P3 OASIS-1 trial (NCT03482011) in moderate-to-severe plaque psoriasis in Feb 2020 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 1 trial (NCT03518086) in moderate-to-severe ulcerative colitis in Sep 2020 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 LUCENT 1 trial in moderate-to-severe ulcerative colitis in Dec 2021; Primary completion and completion of P2 SHINE 1 trial (NCT04004611) in children and teenagers with ulcerative colitis in Aug 2022 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 2 trial (NCT03524092) in moderate-to-severe ulcerative colitis in Jun 2021 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 LUCENT 2 trial in moderate-to-severe ulcerative colitis in Jun 2023; Primary completion and completion of P3 LUCENT 3 trial (NCT03519945) in moderate-to-severe ulcerative colitis in Aug 2023 
[Screenshot]

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma to present new phase 3 data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting (GlobeNewswire) – Oct 28, 2019 – “RedHill Biopharma Ltd…announced that two oral presentations and two posters on two of the Company’s leading drug candidates, RHB-1051 (Talicia®, H. pylori infection) and RHB-104 (Crohn’s disease) will be presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting, being held October 25-30, in San Antonio, Texas.”

 

etrasimod (APD334) / Arena
Etrasimod US sales projection: $665M peak for ulcerative colitis (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68047432; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals Inc – Management dinner takeaways”; AUTHOR: Research Department; DATE: 10/03/2019

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Weekly Top News – IBD – October 21, 2019

October 21, 2019

Stelara (ustekinumab) / J&J
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (PRNewswire) – Oct 21, 2019 – “The Janssen Pharmaceutical Companies…announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission.”

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Initiation of P2b/3 CULTIVATE trial for Crohn’s disease in Q4 2019 (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68024735; Page no: 3; REPORT TITLE: “Companies, catalysts and controversies: Top questions for management at our upcoming global healthcare conference”; AUTHOR: Research Department; DATE: 09/29/2019

etrolizumab (RG7413) / Roche
Etrolizumab: Regulatory submissions in US/EU for Crohn’s disease in 2022 or later (Roche) – Oct 16, 2019 – Q3 2019 Results 
[Screenshot]

 

Stelara (ustekinumab) / J&J
Stelara (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial (Businesswire) – Oct 21, 2019 – P3, N=399; UNIFI (NCT02407236); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies…announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented today as a late-breaking data presentation (LB01) at the 27th UEGW congress…Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission…Results from the UNITI Crohn’s disease (CD) clinical trial programme are also being presented at the congress.”

 

Alofisel (darvadstrocel) / Takeda
Approved a drug with stem cells for Crohn’s fistulas [Google Translation] (Webconsultas Healthcare) – Oct 18, 2019 – “Spanish researchers have discovered and developed a drug, darvadstrocel (marketed as Alofisel ), made with stem cells obtained from donor fat to treat complex perianal fistulas in patients with Crohn’s disease…This medicine…is the first allogeneic cell therapy approved in Europe, is already approved by the Ministry of Health, Consumption and Social Welfare and will be funded by Social Security.”

 

BMS-986165 / BMS
BMS-986165 sales projection: $2.4B in 2027 (Guggenheim) – Oct 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 68074910; Page no: 19; REPORT TITLE: “3Q global pharma preview: Another solid quarter likely tempered by politics & policy”; AUTHOR: Fernandez, Seamus, et al; DATE: 10/09/2019

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals’ presence at United European Gastroenterology Week bolsters commitment to the gastrointestinal disease community (Arena Press Release) – Oct 18, 2019 – “Arena Pharmaceuticals, Inc…will present new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod…in patients with moderately to severely active ulcerative colitis (UC) at the 25th Annual United European Gastroenterology (UEG) Week…UEG Week is taking place October 19-23, 2019, in Barcelona, Spain.”

 

etrasimod (APD334) / Arena
Etrasimod US sales projection: $665M peak for ulcerative colitis (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68047432; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals Inc – Management dinner takeaways”; AUTHOR: Research Department; DATE: 10/03/2019

 

Otezla (apremilast) / Amgen
Otezla WW revenue projection: $1,917M in 2019 (Jefferies) – Oct 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 68079059; Page no: 30; REPORT TITLE: “Q3 EPS and thoughts into year-end”; AUTHOR: Yee, Michael, et al; DATE: 10/10/2019

 

Rinvoq (upadacitinib) / AbbVie; Xeljanz (tofacitinib) / Pfizer
In a U-turn, ICER takes more positive view of AbbVie’s Rinvoq (PMLive) – Oct 14, 2019 – “The Institute for Clinical and Economic Review (ICER) has shifted its position on the value of AbbVie’s Rinvoq (upadacitinib), bringing the rheumatoid arthritis drug under its quality-adjusted life-year (QALY) threshold….ICER has changed some of the parameters and inputs for the value models described in the report…Under the revised model, the incremental QALY for Rinvoq versus Humira came in at $92,000, below the $150,000 threshold used by ICER….Notably, the statement that Rinvoq ‘provided marginal clinical benefit…The revised report also retains a skeptical view about the value of Xeljanz and Olumiant….One of ICER’s independent committees will discuss the document and hold a vote on it in December.”

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Weekly Top News – IBD – October 14, 2019

October 14, 2019

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Data from P3 TRUE NORTH trial (NCT02435992) for moderate-to-severe ulcerative colitis in mid-2020 (Guggenheim) – Oct 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68001013; Page no: 2; REPORT TITLE: “Highlights from our autoImmune/immunology KOL series Part 3: Emerging treatment landscape in Crohn’s Disease and ulcerative colitis”; AUTHOR: Fernandez, Seamus, et al; DATE: 09/24/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Topline data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H1 2020 (Cantor Fitzgerald) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016498; Page no: 1; REPORT TITLE: “Cantor conference class of 2019: Top questions, catalysts, and who is most likely to….”; AUTHOR: Research Department; DATE: 09/26/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma Announces Full Results from Positive MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Open-Label Extension Study with RHB-104 in Crohn’s Disease (GlobeNewswire, RedHill Biopharma Ltd.) – Oct 11, 2019 – P3, N=330; MAPUS (NCT01951326); P3, N=331; MAPUS2 (NCT03009396); Sponsor: NCT01951326; “RedHill Biopharma Ltd…announced full Week 52 results for all subjects in the previously announced positive Phase 3 randomized, controlled study of RHB-104 in Crohn’s disease (the ‘MAP US study’) and supportive top-line results from the open-label extension Phase 3 study (the ‘MAP US2 study’). The full Week 52 results of blinded treatment in the MAP US Phase 3 study….continued to meet its primary endpoint…”

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz US sales projection: $2.7B in 2024 (Infinata) – Oct 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 14; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

 

Humira (adalimumab) / Eisai, AbbVie; Remicade (infliximab) / Mitsubishi Tanabe, J&J
HLA-DQA1*05 carriage associated with development of anti-drug antibodies to infliximab and adalimumab in patients with Crohn’s disease (Gastroenterology) – Oct 7, 2019 – P=NA, N=1,240; “We performed a genome-wide association study to identify variants associated with time to development of anti-drug antibodies in…patients with Crohn’s disease starting infliximab or adalimumab therapy…In an observational study, we found a genome-wide significant association between HLA-DQA1*05 and the development of antibodies against anti-TNF agents.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $4B in 2027 (Oppenheimer) – Oct 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68004961; Page no: 1; REPORT TITLE: “Amgen Inc- Key takeaways from meeting with management”; AUTHOR: Research Department; DATE: 09/24/2019

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Weekly Top News – IBD – October 7, 2019

October 7, 2019

Stelara (ustekinumab) / J&J
REAL WORLD EXPERIENCE WITH USTEKINUMAB IN PAEDIATRIC CROHN´S DISEASE. A MULTICENTRE RETROSPECTIVE STUDY FROM PAEDIATRIC IBD PORTO GROUP OF ESPGHAN (UEGW 2019) – Oct 4, 2019 – Abstract #LB05; Pres time: Oct 21, 2019; 02:48 PM – 03:00 PM; Location: F3; “This abstract will be published on October 21, 2019”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi launch estimate: 2022 for Crohn’s disease and 2023 for ulcerative colitis (UBS) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68017232; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Gastroenterology – Takeaways from UBS expert symposium””; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

 

Humira (adalimumab) / Eisai, AbbVie
An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial (clinicaltrialsregister.eu) – Oct 5, 2019 – P4; N=238; Ongoing; Sponsor: GETAID

 

Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer; Remsima SC (infliximab biosimilar SC) / Celltrion
NONINFERIORITY OF NOVEL SUBCUTANEOUS INFLIXIMAB (CT-P13) TO INTRAVENOUS INFLIXIMAB (CT-P13) IN PATIENTS WITH ACTIVE CROHN’S DISEASE AND ULCERATIVE COLITIS: WEEK 30 RESULTS FROM A MULTICENTRE, RANDOMISED CONTROLLED PIVOTAL TRIAL (UEGW 2019) – Oct 4, 2019 – Abstract #LB02; Pres time: Oct 21, 2019; 02:12 PM – 02:24 PM; Location: F3; “This abstract will be published on October 21, 2019”

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $4.3B by 2022 (Deutsche Bank Research) – Oct 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67968779; Page no: 2; REPORT TITLE: “Roche: Pharma day; biosimilar headwinds should soon be in the rear view”; AUTHOR: Parkes, Richard, et al; DATE: 09/17/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq sales projection: $5.6B peak (UBS) – Oct 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016563; Page no: 1; REPORT TITLE: “US Pharmaceuticals “UBS healthcare expert symposium: Dermatology panel key …”; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

 

etrolizumab (RG7413) / Roche
Etrolizumab sales projection: CHF765M in 2025 (Deutsche Bank Research) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67968779; Page no: 2; REPORT TITLE: “Roche Holding Ltd- Roche: Pharma Day; Biosimilar headwinds should soon be in the rear view”; AUTHOR: Parkes, Richard, et al; DATE: 09/17/2019
Sales projection

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9B in 2019 and $2.2B in 2020 (Cowen & Co) – Sep 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2914; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

BMS-986165 / BMS
BMS-986165 sales projection: Consensus of $3.5B peak (Exane BNP Paribas) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67972680; Page no: 38; REPORT TITLE: “Pharmaceuticals: Champions League 2019: Powered by pulse “; AUTHOR: Hector, Luisa, et al; DATE: 09/17/2019

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz sales projection: $1B peak for gastrointestinal disorders (UBS) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68017232; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Gastroenterology – Takeaways from UBS expert symposium””; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

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Weekly Top News – IBD – September 30, 2019

September 30, 2019

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma provides H2/2019 R&D update (GlobeNewswire) – Sep 26, 2019 – “…the last patient enrolled in the open-label extension Phase 3 study with RHB-104 in Crohn’s disease (MAP US2 study) has recently completed their participation in the study. A total of 30 subjects completed 52 weeks of treatment with RHB-104 in the MAP US2 study, with top-line results expected in the fourth quarter of 2019.”

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals presented new data from the phase 2 OASIS trial for etrasimod at the World Congress of Gastroenterology Meeting (PRNewswire) – Sep 26, 2019 – P2, N=156; OASIS (NCT02447302); Sponsor: Arena Pharmaceuticals; “Arena Pharmaceuticals, Inc…presented new data from the Phase 2 OASIS trial for etrasimod…in development for a range of immune-mediated and inflammatory conditions…These data were presented at the World Congress of Gastroenterology Meeting in Istanbul, Turkey. ‘Steady-state etrasimod trough concentrations were achieved and maintained from weeks 1 to 12 in patients with moderately to severely active ulcerative colitis….”

 

Humira (adalimumab) / Eisai, AbbVie; Remicade (infliximab) / Mitsubishi Tanabe, J&J
Micro‐fragmented autologous adipose tissue injection for fistula‐in‐ano (MAATIFA) in patients with Crohn’s disease: a prospective observational study (ESCP 2019) – Sep 28, 2019 – Abstract #P453; “Results Ten patients underwent the procedure in the time interval between two biologic drug administration (6 infliximab –4 adalimumab). Conclusion Micro-fragmented autologous adipose tissue injection showed promising results in promoting Crohn’s-related complex anal fistula healing. These good results are probably related to the reduction of inflammation and the activation of a reparative mechanisms.”

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz sales projection: $2.2B in 2019, $3B in 2020 and $4.1B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 725; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Simponi WW sales projection: $3B in 2019 and $3.7B in 2024 (Cowen & Co) – Sep 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2876; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira patent protection: Until 2022-2034 (Cowen & Co) – Sep 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2872; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Health Care Research, et al; DATE: 09/17/2019

 

mirikizumab (LY3074828) / Eli Lilly
Phase 3 initiation of mirikizumab, a candidate drug for the treatment of immune diseases, for patients with moderate and severe active Crohn’s disease [Google Translation] (Newsmp) – Sep 24, 2019 – “Lilly Korea will conduct a phase 3 clinical trial of a candidate drug for treating immunological diseases in patients with Crohn’s disease in Korea. The Ministry of Food and Drug Safety approved the phase 3 trial of Mirikizumab…filed by Lilly Korea.”

 

Stelara (ustekinumab) / J&J
Stelara WW sales projection: $6.2B in 2019, $7B in 2020 and $10B in 2024 (Cowen & Co) – Sep 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2917; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira patent expiry: January 2023 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 715; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Entyvio (vedolizumab) / Takeda
Limit therapies [Google Translation] (Nasz Dziennik) – Sep 23, 2019 – “Crohn patients are also waiting for the drug vedolizumab (Entyvio) used in many EU countries. In the message sent to us, the Ministry of Health ensures that the specific product will soon be available in Poland. ‘Entyvio (vedolizumab) will be reimbursed from November 1, 2019 as part of a drug program for the treatment of severe, active Crohn’s disease as another therapeutic option in addition to infliximab and adalimumab,’ reads the letter.”

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Weekly Top News – IBD – September 23, 2019

September 23, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P3 Diversity1 trial (NCT02914561) for Crohn’s disease in Q2 2021 (Morgan Stanley) – Sep 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67932681; Page no: 4; REPORT TITLE: “Galapagos NV: Large differentiated pipeline headlined by Filgotinib, resume at OW”; AUTHOR: Harrison, Matthew, et al; DATE: 09/08/2019

 

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 HIBISCUS 1 trial (NCT02163759) for ulcerative colitis in 2020 (Roche) – Sep 17, 2019 – Pharma Day 2019: Data from P3 HIBISCUS 2 trial (NCT02171429) for TNF naive ulcerative colitis in 2020 
[Screenshot]

 

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 HICKORY trial (NCT02100696) for ulcerative colitis in 2020 (Roche) – Sep 17, 2019 – Pharma Day 2019: Data from P3 BERGAMOT trial (NCT02394028) for moderate-to-severe Crohn’s disease in 2021 
[Screenshot]

 

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 LAUREL trial (NCT02165215) for ulcerative colitis in 2020 (Roche) – Sep 17, 2019 – Pharma Day 2019: Data from P3 GARDENIA trial (NCT02136069) for moderate to severe ulcerative colitis in 2020
P3 data
[Screenshot]

foralumab (TZLS-401) / Tiziana Life Sciences
Tiziana Life Sciences announces FDA approval to initiate phase I clinical trial with orally administered foralumab in healthy volunteers (Businesswire) – Sep 16, 2019 – “Tiziana Life Sciences plc…is pleased to announce…that the U.S. Food and Drug Administration (FDA) has allowed the initiation of a Phase I clinical trial in healthy volunteers using a novel oral enteric-coated capsule formulation of Foralumab….This is the first clinical trial in which Foralumab will be administered orally to healthy subjects.”

 

Tremfya (guselkumab) / J&J
Tremfya sales projection: $3B in 2024 (MainFirst Bank AG) – Sep 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 67932139; Page no: 30; REPORT TITLE: “MainFirst AG- Initiating coverage: MainFirst: Morphosys AG (OPF / EUR 140): On the cusp of transformation supported by a fat wallet”; AUTHOR: Wieprecht, Marcus, et al; DATE: 09/08/2019

 

Stelara (ustekinumab) / J&J
Stelara WW sales projection: $9B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 479; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira patent expiry: January 2023 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 715; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq: Newly added patents in Orange Book (Orange Book) – Sep 18, 2019 – Expiry of patents on December 1, 2030, January 15, 2031, October 17, 2036 
[Screenshot]

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $250M in 2019, $850M in 2020 and $3B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 491; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

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Weekly Top News – IBD – September 16, 2019

September 16, 2019

oral etanercept (OPRX-106) / Protalix
OPRX-106 clinical trial estimate: Data from P2 trial (NCT02768974) for ulcerative colitis in H2 2019 (Jefferies) – Sep 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67787343; Page no: 1; REPORT TITLE: “Protalix Biotherapeutics Inc Go-ahead for expedited US path; PRX-102 filing expected in 1Q20”; AUTHOR: Welford, Peter, et al; DATE: 08/08/2019

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Data from P1 trial in healthy volunteers in 2019 (H.C. Wainwright Global Life Sciences Conference 2019, Protagonist Therapeutics) – Sep 11, 2019 
[Screenshot]

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Remicade pricing: $28,906/year (Infinata) – Sep 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 67557275; Page no: 8; REPORT TITLE: “UCB S.A. – Company report”; AUTHOR: Infinata, et al; DATE: 09/03/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.1B in 2020 (CFRA) – Sep 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67896905; Page no: 5; REPORT TITLE: “Amgen Inc.”; AUTHOR: Huang, Kevin, et al; DATE: 08/31/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq sales projection: $236M for ulcerative colitis in 2026 and $690M for ulcerative colitis and Crohn’s disease in 2030 (Infinata) – Sep 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67557855; Page no: 12; REPORT TITLE: “AbbVie Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 09/03/2019

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $4,425M by 2025 (GlobalData) – Sep 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 67577535; Page no: 64; REPORT TITLE: “Takeda Pharmaceutical Co Ltd (4502) – Financial and strategic SWOT analysis review”; AUTHOR: Globaldata, et al; DATE: 09/05/2019

 

Stelara (ustekinumab) / J&J
Serum Institute unveils ₹4,000-cr plant in Pune (The Hindu Business Line) – Sep 9, 2019 – “Union Health Minister…on Monday inaugurated Serum Institute of India’s (SII) new plant with an investment of ₹4,000 crore at Manjri in Pune. The new unit, which will commence operations from November…The unit is built in compliance with the US and European vaccine manufacturing regulations….It will maximise the production of…monoclonal antibodies like…Ustekinumab (Stelara®).”

 

Tremfya (guselkumab) / J&J
Tremfya sales projection: $3B in 2024 (MainFirst Bank AG) – Sep 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 67932139; Page no: 30; REPORT TITLE: “MainFirst AG- Initiating coverage: MainFirst: Morphosys AG (OPF / EUR 140): On the cusp of transformation supported by a fat wallet”; AUTHOR: Wieprecht, Marcus, et al; DATE: 09/08/2019

 

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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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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