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The Digest

Pharma news roundup and Larvol updates

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Category: Inflammatory Bowel Disease

Weekly Top News – IBD – March 30, 2020

March 30, 2020

AVT02 (adalimumab biosimilar) / Alvotech, Cipla
Alvotech and DKSH partner on adalimumab in Asia (Generics Bulletin – Informa) – Mar 26, 2020 – “Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.”

 

ozanimod (RPC1063) / BMS
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=675; Recruiting; Sponsor: Celgene; Trial primary completion date: Feb 2020 –> Mar 2022

 

Humira (adalimumab) / Eisai, AbbVie
Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn’s Disease Patients With Loss of Response ( PRADA ) (clinicaltrials.gov) – Mar 26, 2020 – P=N/A; N=98; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

ozanimod (RPC1063) / BMS
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=535; Recruiting; Sponsor: Celgene; Trial primary completion date: Apr 2021 –> Mar 2023

 

ozanimod (RPC1063) / BMS
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=1040; Recruiting; Sponsor: Celgene; Trial completion date: Oct 2024 –> Jun 2024; Trial primary completion date: Dec 2022 –> Mar 2024

 

ozanimod (RPC1063) / BMS
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=675; Recruiting; Sponsor: Celgene; Trial completion date: Mar 2022 –> Jun 2022; Trial primary completion date: Mar 2020 –> Mar 2022

 

filgotinib (GLPG0634) / Gilead
Galapagos CEO talks next steps as coronavirus stalls the biotech’s top drug (BioPharma Dive) – Mar 25, 2020 – “As the companies await the agency’s decision, they’re investigating filgotinib across other immune-related diseases. A federal database of clinical trials shows 14 ongoing studies testing the drug in Crohn’s disease, ulcerative colitis and psoriatic arthritis, among other conditions….The new coronavirus, however, has prompted Gilead and Galapagos to pause enrollment for more than half of these trials.”

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Weekly Top News – IBD – March 23, 2020

March 23, 2020

Entyvio (vedolizumab) / Takeda
New drug for inflammatory bowel disease in China! Takeda’s Entyvio, the world’s only intestinal selective biologic, approved! [Google Translation] (Bioon.com) – Mar 15, 2020 – “Takeda China announced recently that Entyvio (Anjiyou®, vedolizumab, vedolizumab for injection)…obtained approval from the National Drug Administration (NMPA) to officially enter China, and was approved for moderate to severe active ulcerative colon with inadequate response, inadequate response, or intolerance to traditional treatment or tumor necrosis factor alpha (TNFα) inhibitors Adults with inflammation and Crohn’s disease.”

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Weekly Top News – IBD – March 16, 2020

March 16, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 BERGAMOT trial (NCT02394028) for moderate-to-severe Crohn’s disease in 2021 (Roche, Barclays Global Healthcare Conference 2020) – Mar 13, 2020 
[Screenshot]

 

Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR Pharma
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn’s Disease (clinicaltrials.gov) – Mar 10, 2020 – P3; N=330; Completed; Sponsor: Mesoblast, Inc.; Active, not recruiting –> Completed

 

PN-10-943 / Protagonist Therapeutics; PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics reports fourth quarter and full year 2019 financial results (PRNewswire) – Mar 10, 2020 – “Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (or JNJ-67864238) through completion of a Phase 2a study in patients with moderate-to-severe Crohn’s disease, with the anticipation of completion in the first half of 2021….The Company plans to initiate a Phase 2 study in patients with ulcerative colitis in the second quarter of 2020, with topline data expected in the second half of 2021.”

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Patent expiry in US in 2035 (Protagonist Therapeutics) – Mar 11, 2020 – Annual Report 2019

 

brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Ulcerative Colitis (clinicaltrials.gov) – Mar 11, 2020 – P2; N=300; Enrolling by invitation; Sponsor: Allergan; Not yet recruiting –> Enrolling by invitation

 

Humira (adalimumab) / Eisai, AbbVie
UCanADA: Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (clinicaltrials.gov) – Mar 10, 2020 – P=N/A; N=100; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

UTTR1147A / Roche
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn’s Disease (CD) (clinicaltrials.gov) – Mar 10, 2020 – P1; N=70; Completed; Sponsor: Genentech, Inc.; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: Patent expiry in mid-2026 (Cowen & Co. 40th Annual Health Care Conference 2020, Pfizer) – Mar 13, 2020

 

CERC-002 / Sanofi, Kyowa Hakko Kirin, Cerecor
Cerecor reports 2019 results (GlobeNewswire) – Mar 11, 2020 – “The 2020 organizational focus is driving clinical development programs towards key milestones: CERC-002 (anti-LIGHT mAb) being developed for Pediatric-onset Crohn’s Disease expects initial data readout 2 Half 2020.”

 

Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR Pharma
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn’s Disease (clinicaltrials.gov) – Mar 10, 2020 – P3; N=73; Completed; Sponsor: Mesoblast, Inc.; Active, not recruiting –> Completed; N=120 –> 73

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Weekly Top News – IBD – March 9, 2020

March 16, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 BERGAMOT trial (NCT02394028) for moderate-to-severe Crohn’s disease in 2021 (Roche, Barclays Global Healthcare Conference 2020) – Mar 13, 2020 
[Screenshot]

 

Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR Pharma
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn’s Disease (clinicaltrials.gov) – Mar 10, 2020 – P3; N=330; Completed; Sponsor: Mesoblast, Inc.; Active, not recruiting –> Completed

 

PN-10-943 / Protagonist Therapeutics; PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics reports fourth quarter and full year 2019 financial results (PRNewswire) – Mar 10, 2020 – “Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (or JNJ-67864238) through completion of a Phase 2a study in patients with moderate-to-severe Crohn’s disease, with the anticipation of completion in the first half of 2021….The Company plans to initiate a Phase 2 study in patients with ulcerative colitis in the second quarter of 2020, with topline data expected in the second half of 2021.”

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Patent expiry in US in 2035 (Protagonist Therapeutics) – Mar 11, 2020 – Annual Report 2019

 

brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Ulcerative Colitis (clinicaltrials.gov) – Mar 11, 2020 – P2; N=300; Enrolling by invitation; Sponsor: Allergan; Not yet recruiting –> Enrolling by invitation

 

Humira (adalimumab) / Eisai, AbbVie
UCanADA: Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (clinicaltrials.gov) – Mar 10, 2020 – P=N/A; N=100; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

UTTR1147A / Roche
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn’s Disease (CD) (clinicaltrials.gov) – Mar 10, 2020 – P1; N=70; Completed; Sponsor: Genentech, Inc.; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: Patent expiry in mid-2026 (Cowen & Co. 40th Annual Health Care Conference 2020, Pfizer) – Mar 13, 2020

 

CERC-002 / Sanofi, Kyowa Hakko Kirin, Cerecor
Cerecor reports 2019 results (GlobeNewswire) – Mar 11, 2020 – “The 2020 organizational focus is driving clinical development programs towards key milestones: CERC-002 (anti-LIGHT mAb) being developed for Pediatric-onset Crohn’s Disease expects initial data readout 2 Half 2020.”

 

Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR Pharma
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn’s Disease (clinicaltrials.gov) – Mar 10, 2020 – P3; N=73; Completed; Sponsor: Mesoblast, Inc.; Active, not recruiting –> Completed; N=120 –> 73

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Weekly Top News – IBD – March 9, 2020

March 9, 2020

Entyvio (vedolizumab) / Takeda
Entyvio: “Extension application to introduce a new pharmaceutical form (solution for injection), associated with a new strength (108 mg) and a new route of administration (subcutaneous use)” (EMEA) – Mar 3, 2020 – CHMP Final Minutes of the meeting on 9-12 December 2019: “The Committee discussed the issues identified in this application, mainly relating to some quality and clinical issues”; “The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy (clinicaltrials.gov) – Mar 2, 2020 – P2/3; N=1536; Recruiting; Sponsor: AbbVie; N=720 –> 1536

 

brazikumab (AMG 139) / Allergan
AbbVie and Allergan receive final European approval to close pending transaction (PRNewswire) – Mar 3, 2020 – “AbbVie…and Allergan plc…today announced that the European Commission has approved the divestiture of brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca. The transaction remains subject to additional customary closing conditions…The United States Federal Trade Commission (FTC) continues to review the pending transaction…the companies have entered into a timing agreement with FTC staff that would likely result in a decision by the FTC early in the second quarter of 2020.”

 

Entyvio (vedolizumab) / Takeda
Royalty Pharma acquires royalties on Entyvio from Massachusetts General hospital (PRNewswire) – Mar 5, 2020 – “Royalty Pharma announced today that it has acquired Massachusetts General Hospital’s (MGH) royalty interest in Entyvio (vedolizumab) for $94 million. Entyvio is a monoclonal antibody that is used in the treatment of ulcerative colitis and Crohn’s disease…’Through this transaction with Royalty Pharma, we’ll be able to accelerate our investment in discovery and science for the benefit of patients worldwide.’ ”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
The Interministerial Commission modifies the price of 50 medicines (Acta Sanitaria) – Mar 6, 2020 – “The Interministerial Commission for the Prices of Medicines (CIPM), at its meeting held on February 4, approved three new drugs and decided to review the price of 50…as stated in the information provided by the Ministry of Health….According to the minutes of the CIPM meeting, the Commission approved three new medicines (Skyrizi, from Abbvie…The price set for this drug is € 3,833.49.”

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Weekly Top News – IBD – March 2, 2020

March 2, 2020

TD-1473 / J&J
TD-1473: Data from P2 DIONE trial (NCT03635112) for Crohn’s disease in 2020 or later (Theravance, SVB Leerink 9th Annual Global Healthcare Conference) – Feb 27, 2020 – Data from P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in 2020 or later 
[Screenshot]

 

Stelara (ustekinumab) / J&J
REScUE: Loss of RESponse to Ustekinumab Treated by Dose Escalation (clinicaltrials.gov) – Feb 25, 2020 – P3; N=108; Recruiting; Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW; Not yet recruiting –> Recruiting

 

ozanimod (RPC1063) / BMS
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn’s Disease (clinicaltrials.gov) – Feb 26, 2020 – P2; N=69; Completed; Sponsor: Celgene; Active, not recruiting –> Completed

 

Entyvio SC (vedolizumab SC) / Takeda
Takeda receives positive CHMP opinion for subcutaneous formulation of vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease (Businesswire) – Feb 28, 2020 – “Takeda Pharmaceutical Company Limited…announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a subcutaneous (SC) formulation of…vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Takeda proposes to make vedolizumab SC available in both a pre-filled syringe and a pre-filled pen.”

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Weekly Top News – IBD – February 24, 2020

February 24, 2020

filgotinib (GLPG0634) / Gilead
Filgotinib: Regulatory approval for ulcerative colitis in 2021 (Galapagos) – Feb 22, 2020 – FY 2019 Results

 

brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Ulcerative Colitis (clinicaltrials.gov) – Feb 20, 2020 – P2; N=300; Not yet recruiting; Sponsor: Allergan

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Feb 17, 2020 – P3; N=101; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

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Weekly Top News – IBD – February 17, 2020

February 17, 2020

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 HIBISCUS 2 trial (NCT02171429) for TNF naive ulcerative colitis in mid-2020 (J.P. Morgan) – Feb 15, 2020 – A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: – “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020

 

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 GARDENIA trial (NCT02136069) for moderate to severe ulcerative colitis in mid-2020 (J.P. Morgan) – Feb 15, 2020 – A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: – “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020

 

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 trials LAUREL (NCT02165215), HICKORY (NCT02100696) and HIBISCUS 1 (NCT02163759) for ulcerative colitis in mid-2020 (J.P. Morgan) – Feb 15, 2020 – A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: – “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020

 

carotegrast methyl (AJM300) / Kissei, Eisai
AJM300 clinical trial estimate: Data from P3 trial (NCT03531892) for ulcerative colitis in H2 2020 (J.P. Morgan) – Feb 17, 2020 – A subscription to Thomson ONE is required to gain full access to report 68874313; Page no: 11; REPORT TITLE: “European Pharma & Biotech: Flushing out the UC opportunity: ROG’s etrolizumab seems well positioned, GLGP’s filgotinib could be less differentiated”; AUTHOR: Vosser, Richard, et al; DATE: 02/13/2020

 

Stelara (ustekinumab) / J&J
New phase 3b interim data from STARDUST study show two-thirds of patients with moderately to severely active Crohn’s disease achieved clinical remission after two doses of Stelara (ustekinumab) (PRNewswire) – Feb 14, 2020 – P3b, N=500; STARDUST (NCT03107793); Sponsor: Janssen-Cilag Ltd.; “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical response and 67 percent were in clinical remission…Week 16 data (digital oral presentation, or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as digital oral presentations at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO)….Janssen is presenting a total of 23 abstracts at this year’s ECCO congress.”

 

Entyvio (vedolizumab) / Takeda
Investigational subcutaneous formulation of vedolizumab achieves clinical remission at week 52 in patients with moderately to severely active Crohn’s disease (Businesswire) – Feb 14, 2020 – P3, N=383; VISIBLE 2 (NCT02611830); Sponsor: Takeda; “Takeda Pharmaceutical Company Limited…today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the…vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn’s disease (CD)….The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008])…These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria.”

 

Humira (adalimumab) / Eisai, AbbVie
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn’s Disease (clinicaltrials.gov) – Feb 11, 2020 – P3; N=514; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals’ presence at the European Crohn’s and Colitis Organisation (ECCO) Congress further highlights commitment to the GI community (Arena Press Release) – Feb 11, 2020 – P2, N=156; NCT02447302; Sponsor: Arena; “Arena Pharmaceuticals…announced it will present new data from the open-label extension (OLE) of the Phase 2 OASIS trial for its investigative drug candidate etrasimod, a next-generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, at the 15th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO). The congress is taking place February 12-15, 2020, in Vienna, Austria….Arena is presenting additional data on etrasimod and the unmet need in IBD, as well as hosting a dinner symposium with focused discussion on the integration of histology into a treat-to-target strategy.”

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Weekly Top News – IBD – February 10, 2020

February 10, 2020

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Initiation of P3 trial for ulcerative colitis in 2020 (AbbVie) – Feb 8, 2020 – Pipeline Update: Initiation of P3 trial for atopic dermatitis in 2021 
[Screenshot]

 

ravagalimab (ABBV-323) / AbbVie
Ravagalimab: Initiation of P3 trial for ulcerative colitis in 2021 (AbbVie) – Feb 8, 2020 – Pipeline Update: Proof-of-concept data from P2 trial (NCT03695185) for ulcerative colitis in 2020 
[Screenshot]

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Data from P3 trial for Crohn’s disease in 2020 (AbbVie) – Feb 8, 2020 – Pipeline Update: Data from P3 KEEPSAKE2 trial (NCT03671148) for psoriatic arthritis in 2020 
[Screenshot]

 

TD-1473 / J&J
TD-1473: Data from P2 DIONE trial (NCT03635112) for Crohn’s disease in late 2020 (Theravance) – Feb 6, 2020 – Investor Presentation: Data from P2b portion of P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in late 2020 
[Screenshot]

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Data from P2 PRISM trial (NCT04102111) for Crohn’s disease in H1 2021 (Protagonist Therapeutics) – Feb 6, 2020 – Corporate Presentation 
[Screenshot]

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Rinvoq (upadacitinib) / AbbVie
AbbVie reports full-year and fourth-quarter 2019 financial results (PRNewswire) – Feb 7, 2020 – “‘The launches of Skyrizi and Rinvoq are going extremely well, and we are entering 2020 with substantial momentum. We also look forward to completing the planned Allergan acquisition in the first quarter.’…Global SKYRIZI net revenues were $216 million and global RINVOQ net revenues were $33 million….Detailed data from both pivotal studies will be presented at an upcoming medical meeting and AbbVie expects to submit our regulatory applications for RINVOQ in PsA in the second quarter of this year.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Regulatory submissions for Crohn’s disease and psoriatic arthritis in 2021 (AbbVie) – Feb 8, 2020 – Pipeline Update 
[Screenshot]

 

Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Amgen launches biosimilar for the treatment of inflammatory diseases [Google translation] (PRNewswire) – Feb 3, 2020 – “Amgen…announces the launch and commercialization of the first biosimilar medicine of the molecule adalimumab available in Brazil. AMGEVITA® was approved by the National Health Surveillance Agency (ANVISA), with indication for the treatment of several inflammatory diseases, such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis or ulcerative colitis, plaque psoriasis, uveitis and hydradenitis suppurative.”

 

Humira (adalimumab) / Eisai, AbbVie
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis (clinicaltrials.gov) – Feb 5, 2020 – P3; N=59; Active, not recruiting; Sponsor: AbbVie; Enrolling by invitation –> Active, not recruiting; N=93 –> 59; Trial completion date: Mar 2026 –> May 2025; Trial primary completion date: May 2023 –> Mar 2025

 

Humira (adalimumab) / Eisai, AbbVie
AbbVie reports full-year and fourth-quarter 2019 financial results (PRNewswire) – Feb 7, 2020 – “Fourth-Quarter Results: Worldwide net revenues were $8.704 billion, an increase of 4.8 percent…Excluding the unfavorable impact of international HUMIRA net revenues due to biosimilar competition, fourth-quarter net revenues grew 11.0 percent operationally. U.S. HUMIRA net revenues were $3.969 billion, an increase of 9.8 percent. Internationally, HUMIRA net revenues were $948 million, a decrease of 27.3 percent…due to biosimilar competition.”

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Weekly Top News – IBD – February 3, 2020

February 3, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission in US for ulcerative colitis in 2020 (Roche) – Jan 30, 2020 – FY 2019 Results: Regulatory submission in EU for ulcerative colitis in 2020 
[Screenshot]

 

Stelara (ustekinumab) / J&J
REScUE: Loss of RESponse to Ustekinumab Treated by Dose Escalation (clinicaltrials.gov) – Jan 28, 2020 – P3; N=108; Not yet recruiting; Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The CHMP adopted an opinion by consensus based on the PRAC recommendation [Ulcerative colitis]” (EMEA) – Jan 28, 2020 – CHMP Final Minutes for the meeting on 11-14 November 2019: “The Committee recommended that the marketing authorisations for Xeljanz should be varied. It was recommended that Xeljanz should be used with caution in all patients at high risk of blood clots”

 

Stelara (ustekinumab) / J&J
Health Canada approves new indication for Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (Canada Newswire) – Jan 27, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial…”

 

brazikumab (AMG 139) / Allergan
Abbvie and Allergan announce agreements to divest brazikumab and Zenpep (Allergan Press Release) – Jan 27, 2020 – “AbbVie…today announced that Allergan has entered into definitive agreements to divest brazikumab (IL-23 inhibitor)…AstraZeneca…will acquire brazikumab…in Phase 2b/3 development for Crohn’s Disease and in Phase 2 development for ulcerative colitis, including global development and commercial rights….AbbVie and Allergan continue to expect a first-quarter 2020 close of their pending transaction, subject to receipt of required regulatory approvals and other closing conditions.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira sales projection: $20B peak (Credit Suisse) – Jan 29, 2020 – A subscription to Thomson ONE is required to gain full access to report 68679165; Page no: 22; REPORT TITLE: – “First edition summary Europe: Monday, 20 January, 2020”; AUTHOR: Product Marketing, Credit Suisse E, et al; DATE: 01/20/2020

 

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $517M for Crohn’s disease by 2030 (Morgan Stanley) – Jan 30, 2020 – A subscription to Thomson ONE is required to gain full access to report 68667865; Page no: 129; REPORT TITLE: – “Biotechnology: Quick 4Q19 preview”; AUTHOR: Harrison, Matthew, et al; DATE: 01/17/2020

 

Alofisel (darvadstrocel) / Takeda
Alofisel sales projection: $250M in 2024 (Bank Vontobel) – Jan 28, 2020 – A subscription to Thomson ONE is required to gain full access to report 68642122; Page no: 15; REPORT TITLE: – “Lonza (BUY, PT CHF 390) – An in-depth look into Lonza’s biologics businesses – the pearl and main growth driver of Lonza going forward”; AUTHOR: Buchta, Daniel, et al; DATE: 01/14/2020

 

phosphatidylcholine CR (LT‑02) / Lipid Therap, Nestle, Dr Falk
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) (clinicaltrials.gov) – Jan 27, 2020 – P3; N=150; Completed; Sponsor: Dr. Falk Pharma GmbH; Active, not recruiting –> Completed

 

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata (clinicaltrials.gov) – Jan 27, 2020 – P; N=4000; Not yet recruiting; Sponsor: Momentum Data

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