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Pharma news roundup and Larvol updates

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Category: Inflammatory Bowel Disease

Weekly Top News – IBD– January 20, 2020

January 20, 2020

mirikizumab (LY3074828) / Eli Lilly
VIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Jan 18, 2020 – P3; N=778; Not yet recruiting; Sponsor: Eli Lilly and Company

 

filgotinib (GLPG0634) / Gilead
Filgotinib US regulatory estimate: Submission for ulcerative colitis in H2 2020 (Wells Fargo) – Jan 18, 2020 – A subscription to Thomson ONE is required to gain full access to report 68595639; Page no: 21; REPORT TITLE: “Biotech sector outlook – Fundamental/strategic value outweighs E”; AUTHOR: Birenchenough, James, et al; DATE: 01/05/2020

 

etrasimod (APD334) / Arena
Etrasimod: Data from P3 trial for Crohn’s disease in 2022 (Arena) – Jan 16, 2020 – Corporate Presentation
P3 data
[Screenshot]

etrasimod (APD334) / Arena
Etrasimod: Completion of enrollment of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in 2020 (Arena) – Jan 16, 2020 – Corporate Presentation: Data from P3 ELEVATE UC 12 trial (NCT03996369) for ulcerative colitis in 2021 
[Screenshot]

 

etrasimod (APD334) / Arena
Etrasimod: NDA submission for ulcerative colitis in 2022 (Arena) – Jan 16, 2020 – Corporate Presentation 
[Screenshot]

 

etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn’s Disease (clinicaltrialsregister.eu) – Jan 16, 2020 – P2; N=225; Ongoing; Sponsor: Arena Pharmaceuticals Inc.

 

Entyvio (vedolizumab) / Takeda
Takeda’s Quintiles [sic] expands indication for ulcerative colitis, Crohn’s disease (Korea Biomedical Review) – Jan 17, 2020 – “The Ministry of Food and Drug Safety recently granted the nod to Quintiles [sic] (ingredient: vedolizumab) as the first-line therapy for ulcerative colitis and Crohn’s disease….In recent trials, Quintiles [sic] showed statistically superior clinical remission, compared to existing TNF-alpha inhibitors.”

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 15, 2020 – P3; N=101; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed; Trial completion date: Sep 2020 –> Dec 2019; Trial primary completion date: Jun 2020 –> Dec 2019

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 18, 2020 – P3; N=101; Active, not recruiting; Sponsor: AbbVie; Completed –> Active, not recruiting

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz patent expiry: Late 2025 in US (RBC Capital Markets (Canada)) – Jan 17, 2020 – A subscription to Thomson ONE is required to gain full access to report 68599422; Page no: 13; REPORT TITLE: “Pfizer Inc. – P&L to inflect off more innovative high growth base; Initiate at OP, $46 target”; AUTHOR: Stanicky, Randall, et al; DATE: 01/06/2020

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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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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 – IBD– December 30, 2019

December 30, 2019

PF-06826647 / Pfizer
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis (clinicaltrials.gov) – Dec 24, 2019 – P2b; N=202; Not yet recruiting; Sponsor: Pfizer

 

filgotinib (GLPG0634) / Gilead
Filgotinib regulatory estimate: Approval for ulcerative colitis around mid-2020 (Barclays) – Dec 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68490284; Page no: 6, 1; REPORT TITLE: “Galapagos: Christmas comes early for GLPG holders – thoughts on the recent outperformance”; AUTHOR: Field, Emily, et al; DATE: 12/13/2019

 

filgotinib (GLPG0634) / Gilead
Gilead and Eisai enter into agreement in Japan for the co-promotion of the investigational rheumatoid arthritis therapy filgotinib, pending regulatory approval (Businesswire) – Dec 24, 2019 – “Gilead Sciences, Inc….and Eisai Co., Ltd….announced today that Gilead Sciences K.K. (Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib…in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.”

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200 regulatory estimate: Approval for Crohn’s disease in 2023 (BTIG) – Dec 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68441439; Page no: 7; REPORT TITLE: “Protagonist Therapeutics, Inc. – Sell off in shares on PTG-300 preliminary data in beta-thalassemia seems overdone”; AUTHOR: Chiang, Timothy, et al; DATE: 12/04/2019

 

Entyvio (vedolizumab) / Takeda
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study (clinicaltrials.gov) – Dec 23, 2019 – P4; N=60; Suspended; Sponsor: Takeda; Trial completion date: Jul 2019 –> Aug 2020; Recruiting –> Suspended; Trial primary completion date: Jul 2019 –> Aug 2020

 

Stelara (ustekinumab) / J&J
SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (clinicaltrials.gov) – Dec 26, 2019 – P3b; N=384; Active, not recruiting; Sponsor: Janssen Scientific Affairs, LLC; Recruiting –> Active, not recruiting

 

BBT-401 / Bridge Bio, Daewoong Pharma
Bridge Biotherapeutics announces China NMPA clearance of IND for BBT-401, a pellino-1 inhibitor for UC (PRNewswire) – Dec 26, 2019 – “Bridge Biotherapeutics Inc…announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) cleared the Investigational New Drug (IND) application submitted as of September 25, 2019 for BBT-401, a potent first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis (UC). Bridge Biotherapeutics plans to initiate a Phase I study of BBT-401 in Chinese subjects in May 2020…The study will include 30 healthy volunteers and is targeting to complete by end of 2020.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Xifaxan sales projection: $1.4B in 2019 (Guggenheim) – Dec 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502576; Page no: 8; REPORT TITLE: “Bausch Health Companies Ltd- BHC (Buy) – BHC (Buy) – Hepatic encephalopathy (HE) deep dive ahead of phase 2 data”; AUTHOR: Research Department; DATE: 12/16/2019

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $4,425M by 2025 (GlobalData) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 67577535; Page no: 71; REPORT TITLE: “Takeda Pharmaceutical Co Ltd (4502) – Financial and strategic SWOT analysis review”; AUTHOR: Globaldata; DATE: 12/18/2019

 

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

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Weekly Top News – IBD– December 23, 2019

December 23, 2019

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104: “Durable remission weeks 16-52: statistically significant benefit in durable remission on all visits, weeks 16-52, demonstrating an improvement of 100% over placebo”; Crohn’s disease (RedHill) – Dec 19, 2019 – Corporate Presentation 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Top-line data from P3 trials LUCENT 1 (NCT03518086), LUCENT 2 (NCT03524092) and LUCENT 3 (NCT03519945) for ulcerative colitis in 2020 (Eli Lilly) – Dec 18, 2019 – 2020 Financial Guidance Call 
[Screenshot]

 

Remsima SC (infliximab biosimilar SC) / Celltrion
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Dec 19, 2019 – P3; N=615; Not yet recruiting; Sponsor: Celltrion

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The Committee confirmed that all issues previously identified in this application had been addressed [extension application to introduce a new pharmaceutical form (prolonged-release tablet) associated with a new strength (11 mg), and presented in pack sizes of 28, 30, 90 and 91 tablets].” (EMEA) – Dec 20, 2019 – CHMP Final Minutes for the meeting on 14-17 October 2019: “The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.”

 

SHP647 / Takeda
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) (clinicaltrials.gov) – Dec 17, 2019 – P3; N=3384; Recruiting; Sponsor: Shire; N=2453 –> 3384

 

QBECO / Qu biologics
Qu Biologics Completes Enrollment in First Stage of Phase 2 Clinical Trial in Moderate to Severe Crohn’s Disease (GlobeNewswire, Qu Biologics, Inc.) – Dec 18, 2019 – “Qu Biologics Inc…is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, ‘A Phase 2…Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease’. In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function.”

 

ravagalimab (ABBV-323) / AbbVie
A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) – Dec 19, 2019 – P2; N=30; Recruiting; Sponsor: AbbVie; N=60 –> 30; Trial completion date: May 2022 –> Nov 2021

 

ABX464 / Abivax
Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients Odslepená udržiavacia liečba pacientov so stredne závažnou až závažnou ulceróznou kolitídou (clinicaltrialsregister.eu) – Dec 19, 2019 – P2; N=232; Ongoing; Sponsor: ABIVAX

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Weekly Top News – IBD– December 16, 2019

December 16, 2019

Xeljanz XR (tofacitinib XR) / Pfizer
FDA approves Xeljanz XR (tofacitinib) extended-release tablets for the treatment of ulcerative colitis (Pfizer Press Release) – Dec 12, 2019 – “Pfizer Inc…announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers.”

 

TD-1473 / J&J
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) – Dec 11, 2019 – P2/3; N=500; Not yet recruiting; Sponsor: Theravance Biopharma; Initiation date: Nov 2019 –> Feb 2020

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
ADAPT: An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease (clinicaltrials.gov) – Dec 9, 2019 – P4; N=55; Terminated; Sponsor: Janssen Scientific Affairs, LLC; Completed –> Terminated; Study was terminated due to the inability to enroll a sufficient number of the required subject population

 

NI-071 (infliximab biosimilar) / Sanofi, Nichi-Iko, Binex, Aprogen
Korea’s 11th unicorn company ‘Aprogen’ is the only biotechnology company [Google Translation] (Sisaweek) – Dec 10, 2019 – “…the company has successfully developed ‘GS071’ (Japan NI071), a biosimilar that is used to treat autoimmune diseases such as rheumatoid arthritis and Crohn’s disease…Aprogen plans to apply for the GS071 in the US next year and obtain a US product approval in 2021.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $178M in Q4 2019 (UBS) – Dec 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68424496; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/29/2019

 

ozanimod (RPC1063) / BMS
Ozanimod sales projection: Consensus of $1B in 2022 (William O Neil) – Dec 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 68456923; Page no: 5; REPORT TITLE: “WON Global view — December 6, 2019”; AUTHOR: Research Department; DATE: 12/06/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq WW sales projection: $530M in 2020, $1,004M in 2021 and $1,963M in 2022 (Piper Jaffray) – Dec 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68437953; Page no: 1; REPORT TITLE: “Abbvie Inc – New rheumatologist survey indicates Rinvoq is trending ahead of expectations”; AUTHOR: Raymond, Christopher, et al; DATE: 12/03/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Alberta will force patients to switch from biologics to cheaper biosimilar medications (The Globe and Mail) – Dec 12, 2019 – “Alberta will force 26,000 patients on government-sponsored drug plans to switch from expensive drugs that are known as biologics to cheaper near-copies of the medications, a move that will save the province hundreds of millions of dollars in the coming years…Alberta’s plan will require existing patients on government-sponsored drug plans to switch to the biosimilar versions of Remicade….The changes, which kick in July 1, 2020, do not apply to patients with private insurance or patients who pay out of pocket for their prescription drugs.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn’s Disease Who Failed Prior Biologic Treatment (clinicaltrials.gov) – Dec 9, 2019 – P3; N=579; Recruiting; Sponsor: AbbVie; Trial completion date: Jun 2020 –> Mar 2021; Trial primary completion date: Jun 2020 –> Mar 2021

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Weekly Top News – IBD – December 9, 2019

December 9, 2019

Avsola (infliximab-axxq) / Amgen
FDA approves Amgen’s Avsola (infliximab-axxq), for the same indications as Remicade (infliximab) (Amgen Press Release) – Dec 6, 2019 – “Amgen…announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)…AVSOLA, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which included comparative analytical, nonclinical and clinical data.”

 

Humira (adalimumab) / Eisai, AbbVie
CONTROL: A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab (clinicaltrials.gov) – Dec 3, 2019 – P4; N=238; Not yet recruiting; Sponsor: Groupe d’Etude Therapeutique des Affections Inflammatoires Digestives

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J; Humira (adalimumab) / Eisai, AbbVie
Tetra Therapeutics announces presentation of data from retrospective population-based study of 56 million patients at the 12th Clinical Trials on Alzheimer’s Disease Meeting (CTAD) (Businesswire) – Dec 4, 2019 – “Tetra Therapeutics…today announced a poster presentation at the 12th Clinical Trials on Alzheimer’s Disease Meeting (CTAD) being held in San Diego, from December 4 – 7….The poster, titled ‘Tumor Necrosis Factor (TNF) Blocking Agents Reduce Risk for Alzheimer’s Disease in Patients with Rheumatoid Arthritis and Psoriasis,’ highlights data from a retrospective population-based study of 56 million patients in which inflammatory disease in the body is shown to increase risk for Alzheimer’s disease and that risk can be reduced in these patients by treatment with a TNF blocking drug.”

 

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) – Dec 4, 2019 – P3; N=350; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting –> Active, not recruiting

 

ozanimod (RPC1063) / BMS
Ozanimod clinical trial estimate: Primary completion of P3 YELLOWSTONE trial (NCT03440372) for moderate to severe Crohn’s disease in February 2020 and final completion of trial in April 2022 (Morgan Stanley) – Dec 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 68388355; Page no: 22; REPORT TITLE: “Bristol-Myers Squibb: Enhanced cancer leadership, but high patent exposure; Resuming at EW”; AUTHOR: Risinger, David, et al; DATE: 11/22/2019

 

ozanimod (RPC1063) / BMS
Ozanimod sales projection: $530M in 2023 (Morgan Stanley) – Dec 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 68388355; Page no: 19; REPORT TITLE: “Bristol-Myers Squibb: Enhanced cancer leadership, but high patent exposure; Resuming at EW”; AUTHOR: Risinger, David, et al; DATE: 11/22/2019

 

Alofisel (darvadstrocel) / Takeda
Alofisel WW sales projection: Consensus of $252M in 2024 (Bell Potter) – Dec 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 68226796; Page no: 6; REPORT TITLE: “Mesoblast Ltd- MSB: 1QFY20 – Another record quarter for Temcell”; AUTHOR: Jain, Tanushree, et al; DATE: 10/31/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Dec 6, 2019 – P3; N=940; Recruiting; Sponsor: AbbVie; Trial completion date: Oct 2020 –> Mar 2021; Trial primary completion date: Oct 2020 –> Mar 2021

 

Tremfya (guselkumab) / J&J
Tremfya sales projection: >$2.5B peak (Trefis) – Dec 7, 2019 – A subscription to Thomson ONE is required to gain full access to report 68403255; Page no: 3; REPORT TITLE: “Johnson & Johnson- Trefis report: Johnson & Johnson – $161 Trefis price estimate”; AUTHOR: Research Department, et al; DATE: 11/26/2019

 

GiFD: Screening of Fabry Disease in Patients With GI Symptoms (clinicaltrials.gov) – Dec 4, 2019 – P; N=200; Recruiting; Sponsor: General University Hospital, Prague

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Weekly Top News – IBD – December 2, 2019

December 2, 2019

Alofisel (darvadstrocel) / Takeda
ADMIRE-CD: Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn’s Disease (clinicaltrials.gov) – Nov 29, 2019 – P3; N=278; Completed; Sponsor: Tigenix S.A.U.; Active, not recruiting –> Completed

 

Alofisel (darvadstrocel) / Takeda
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula (clinicaltrials.gov) – Nov 29, 2019 – P3; N=150; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Not yet recruiting –> Recruiting

 

Humira (adalimumab) / Eisai, AbbVie
Humira pricing: RMB3,160/40mg injection (BUYSELLSIGNALS RESEARCH) – Nov 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68415684; Page no: 40; REPORT TITLE: “Shanghai Henlius Biotech Co Ltd- Shanghai Henlius Biotech plummets 9% in past month”; AUTHOR: Research Team, et al; DATE: 11/27/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $3.3B in 2025 (UBS) – Nov 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 68367849; Page no: 2; REPORT TITLE: “AbbVie “Greater certainty to key growth assets – PT to $96” (Buy) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/18/2019

 

Tremfya (guselkumab) / J&J
Tremfya sales projection: $4.6B in 2029 (Guggenheim) – Nov 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 68374268; Page no: 71; REPORT TITLE: “Initiating coverage: Innovative oncology antibody platforms-next leg of industry growth not a three-legged stool”; AUTHOR: Darout, Etzer, et al; DATE: 11/19/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.7B in 2022 (Cowen & Co) – Nov 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68386681; Page no: 2; REPORT TITLE: “Celgene Corp – Discontinuing coverage”; AUTHOR: Werber, Md, Yaron, et al; DATE: 11/21/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib WW sales projection: $2B peak for rheumatoid arthritis and IBD (Jefferies) – Nov 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 68348316; Page no: 5; REPORT TITLE: “Galapagos NV: Filgotinib, Toledo and IPF in focus with key IPF interim later than hoped”; AUTHOR: Welford, Peter, et al; DATE: 11/14/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq US sales projection: $39M (consensus: $41M) in FY2019 (UBS) – Nov 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68354122; Page no: 4; REPORT TITLE: “US Pharmaceuticals “*New* Rinvoq – Drug launches – Weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/15/2019

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz patent expiry: Related to enantiomer in 2022 and related to polymorphic form in 2023 (Corporate Watchdog) – Nov 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 68393470; Page no: 26; REPORT TITLE: “Pfizer Inc. – Watchdog report: PFE – Red flags and warning signs”; AUTHOR: Research Department; DATE: 11/22/2019

 

Humira (adalimumab) / Eisai, AbbVie
China updates drug reimbursement list, agrees price cuts (PMLive) – Nov 29, 2019 – “Chinese regulators have added 70 new medicines to the country’s National Reimbursement Drug List (NRDL), and has agreed an average of 61% in price cuts with pharma companies. The key drugs which have been added to the list include AbbVie’s blockbuster drug Humira (adalimumab), Novartis’ dermatitis drug Xolair (omalizumab)…. According the NHSA, Chinese citizens can use their state medical insurance to cover a significant amount of the cost of the drugs added to the list.”

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Weekly Top News – IBD – November 25, 2019

November 25, 2019

Humira (adalimumab) / Eisai, AbbVie
Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Nov 22, 2019 – P3; N=952; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan clinical trial estimate: Interim data from P2 trial (NCT03515044) for overt hepatic encephalopathy in Q4 2019 (Cowen & Co) – Nov 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 68320235; Page no: 2; REPORT TITLE: “Bausch Health Companies Inc- Model update: Thesis unchanged – Reiterate (1)”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/11/2019

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Data from P2 trial for Crohn’s disease in H1 2021 (Stifel 2019 Healthcare Conference, Protagonist Therapeutics) – Nov 21, 2019 
[Screenshot]

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The Committee discussed the issues identified in this application, mainly concerning the clinical efficacy data and the feasibility of a registry analyses [extension application to introduce a new pharmaceutical form (prolonged-release tablet) associated with a new strength (11 mg)]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The Committee adopted the CHMP recommendation and scientific discussion together with a 3rd list of outstanding issues and a specific timetable.”

 

etrasimod (APD334) / Arena
CULTIVATE: A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Nov 21, 2019 – P2b; N=225; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

filgotinib (GLPG0634) / Gilead
Filgotinib pricing projection: $50,00/year (SunTrust) – Nov 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 68321433; Page no: 59; REPORT TITLE: “Gilead Sciences Inc.-Initiating coverage – Initiating at Hold and $70 PT; HIV deep-dive on patent cliffs & PrEP”; AUTHOR: Research Department; DATE: 11/11/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Doctor urges Alberta not to switch coverage to cheaper meds for patients with IBD (Yahoo News) – Nov 21, 2019 – “Alberta is looking to switch to covering a cheaper alternative medication for patients with inflammatory bowel disease (IBD) — a move an expert says could harm some patients’ health…The minister’s office said in the past decade, the province’s spending on biologics has increased from around $20 million per year to more than $200 million…But the maker of Remicade, one of the biologics for Crohn’s patients that would be impacted, said it has reached out to the government to offer its product at a cost comparable to biosimilars.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Patent delisted for Xifaxan from Orange Book (Orange Book) – Nov 20, 2019 – Patent no. 10314828 
[Screenshot]

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Weekly Top News – IBD – November 18, 2019

November 18, 2019

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 COTTONWOOD trial (NCT02118584) for advanced ulcerative colitis in 2020 (Roche) – Nov 13, 2019 – ASN/ACR 2019 
[Screenshot]

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Launch in UK, Germany and Benelux for ulcerative colitis in 2021 (Galapagos) – Nov 15, 2019 – Annual R&D Update 
[Screenshot]

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan clinical trial estimate: Interim data from P2 trial (NCT03515044) for overt hepatic encephalopathy in Q4 2019 (Cowen & Co) – Nov 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 68320235; Page no: 2; REPORT TITLE: “Bausch Health Companies Inc- Model update: Thesis unchanged – Reiterate (1)”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/11/2019

 

Xeljanz (tofacitinib) / Pfizer
EMA cautions on Pfizer’s Xeljanz (SeekingAlpha) – Nov 15, 2019 – “Citing data from an ongoing study…the European Medicines Agency recommends that Pfizer’s…rheumatoid arthritis med Xeljanz (tofacitinib) be used with caution in all patients at high risk of blood clots. Combined results from multiple sources showed that the risk of blood clots in deep veins and lungs was higher in patients taking Xeljanz, especially the 10 mg twice-daily dose, and those being treated for an extended period.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $167M (consensus: $98M) in Q4 2019 (UBS) – Nov 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 68304392; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/08/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Newly added patent in Orange Book (Orange Book) – Nov 14, 2019 – Expiry on February 26, 2029 
[Screenshot]

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $134M in Q4 2019 (Credit Suisse) – Nov 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 68256114; Page no: 10; REPORT TITLE: “Credit Suisse India daily: Top stories and ideas”; AUTHOR: Gupta, Ashish, et al; DATE: 11/04/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $250M in CY2019 and $2-3B peak (Jefferies) – Nov 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 68296514; Page no: 1; REPORT TITLE: “Sun Pharmaceutical Industries Ltd – 2Q20: In- line quarter as strong India offset US weakness”; AUTHOR: Nahar, Piyush, et al; DATE: 11/07/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $1.7B by 2023 (Credit Suisse) – Nov 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 68234984; Page no: 32; REPORT TITLE: “Last Edition – US: Thursday, October 31, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 10/31/2019

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