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Category: Inflammatory Bowel Disease

Weekly Top News – IBD – July 15, 2019

July 15, 2019

etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 9, 2019 – P3; N=372; Sponsor: Arena Pharmaceuticals Inc.

 

filgotinib (GLPG0634) / Gilead
Filgotinib US launch estimate: 2022+ for moderate-to-severe IBD (Credit Suisse) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67561676; Page no: 9; REPORT TITLE: “First edition – US alert: Tuesday, July 2, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 07/02/19

 

PF-06700841 / Pfizer; PF-06651600 / Pfizer
PF-06651600 + PF‑06700841 clinical trial estimate: Primary completion of P2a trial (NCT03395184) for Crohn’s disease in February 2020 (Morgan Stanley) – Jul 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 18; REPORT TITLE: “Pfizer Inc – Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J; Tremfya (guselkumab) / J&J
Celsius Therapeutics signs collaboration agreement with Janssen to identify response biomarkers for ulcerative colitis (Businesswire) – Jul 9, 2019 – “Celsius Therapeutics…announced a collaboration with Janssen Biotech, Inc. Under the terms of the agreement, Celsius will apply its proprietary single-cell genomics and machine learning platform to identify predictive biomarkers of response from Janssen’s VEGA study, a Phase 2a clinical trial evaluating the efficacy and safety of combination therapy with guselkumab and golimumab in patients with ulcerative colitis.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $1.7B peak (Wells Fargo) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67559640; Page no: 1; REPORT TITLE: “Gilead Sciences Inc- GILD: Path forward for Filgotinib in RA”; AUTHOR: Research Department; DATE: 07/01/2019

 

Otezla (apremilast) / Celgene
Otezla patent expiry: Between 2023-2034 and 2023 for drug substance patent (Guggenheim) – Jul 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67532791; Page no: 2; REPORT TITLE: “Bristol-Myers Squibb Co. – BMY – They’re not gonna give Otezla away…but need to sell adds uncertainty & impacts timing”; AUTHOR: Fernandez, Seamus, et al; DATE: 06/25/2019

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz sales projection: $3B peak (Trefis) – Jul 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67553289; Page no: 16; REPORT TITLE: “Pfizer Inc. Trefis Report: Pfizer – $51.64 Trefis price estimate”; AUTHOR: Research Department; DATE: 07/01/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib WW sales projection: $6B ($3B in rheumatoid arthritis, $600M for Crohn’s disease, $400M for ulcerative colitis) peak (Jefferies) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67561267; Page no: 1; REPORT TITLE: “Galapagos NV- Ball’s in FDA’s court with US Filgotinib filing now confirmed for 2019”; AUTHOR: Welford, Peter, et al; DATE: 07/02/19

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Weekly Top News – IBD – July 8, 2019

July 8, 2019

etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 3, 2019 – P3; N=330; Sponsor: Arena Pharmaceuticals, Inc.

 

filgotinib (GLPG0634) / Gilead
Gilead announces intent to submit New Drug Application for filgotinib to U.S. Food and Drug Administration this year (GlobeNewswire) – Jul 2, 2019 – “Gilead Sciences, Inc….today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about…filgotinib. The company discussed with the agency the Phase 3 FINCH studies, as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result…a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira pricing: $40,415/year (Infinata) – Jul 3, 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: 07/01/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Remicade pricing: $28,906/year (Infinata) – Jul 3, 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: 07/01/2019

 

PF-06700841 / Pfizer; PF-06651600 / Pfizer
PF-06651600 + PF‑06700841 clinical trial estimate: Primary completion of P2a trial (NCT03395184) for Crohn’s disease in February 2020 (Morgan Stanley) – Jul 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 18; REPORT TITLE: “Pfizer Inc – Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi revenue projection: Guidance of $150M in H2 2019 (CrispIdea) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67508148; Page no: 3; REPORT TITLE: “Abbvie Inc – Initiating Coverage – Abbvie showing progress in its pipeline by approval of Skyrizi”; AUTHOR: Agarwal, Akansha, et al; DATE: 06/18/2019

 

ABP 710 (infliximab biosimilar) / Amgen
Amgen pulls European application for its biosimilar infliximab ABP 710 (Center for Biosimilars) – Jul 1, 2019 – “Amgen has informed the European Medicines Agency (EMA) it is withdrawing its application for ABP 710, its biosimilar infliximab (Remicade). According to the letter sent to the EMA, Amgen said the decision was due to a change in product strategy.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales estimate: $26M (consensus: $10M) in Q2 2019; Skyrizi sales projection: $221M (consensus: $147M) for FY2019 (UBS) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67522126; Page no: 1; REPORT TITLE: “Abbvie Inc First Read: Abbvie “weekly Skyrizi tracker” (Neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 06/21/2019

 

BMS-986165 / BMS
Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 3, 2019 – P2; N=120; Ongoing; Sponsor: Bristol-Myers Squibb International Corporation

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Newly added patent in Orange Book (Orange Book) – Jul 2, 2019 – Patent expiry on October 2, 2029  
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Weekly Top News – IBD – July 1, 2019

July 2, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from induction part of P3 Diversity1 trial (NCT02914561) for crohn’s disease at end of 2020/early 2021 (Kepler Cheuvreux) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67505266; Page no: 16; REPORT TITLE: “Belgian Life Science Day”; AUTHOR: Landemaine, Thomas, et al; DATE: 06/17/2019

 

etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jun 24, 2019 – P3; N=330; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: 10-week induction part data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H2 2019; 58-week maintenance part data from P2b/3 SELECTION1 trial for ulcerative colitis in H1 2020 (Kepler Cheuvreux) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67505266; Page no: 16; REPORT TITLE: “Belgian Life Science Day”; AUTHOR: Landemaine, Thomas, et al; DATE: 06/17/2019

 

Stelara (ustekinumab) / J&J
Stelara: “The Committee discussed the issues identified in this application, mainly relating to the wording of the indication and the target population [treatment of adult patients with moderately to severely active ulcerative colitis].” (EMEA) – Jun 26, 2019 – CHMP Final Minutes for the meeting on 23-26 April 2019: “The Committee adopted a request for supplementary information with a specific timetable.”

 

Entyvio (vedolizumab) / Takeda
Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn’s Disease] (clinicaltrials.gov) – Jun 28, 2019 – P; N=300; Not yet recruiting; Sponsor: Takeda

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan exclusivity expiry: 2028 (Zacks) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67412332; Page no: 3; REPORT TITLE: “Bausch Health Cos Inc.(BHC) Zacks company report”; AUTHOR: Research Department; DATE: 05/29/2019

 

vidofludimus (IMU-838) / Immunic
Immunic, Inc. to present previously unpublished data regarding lead program, IMU-838, at the GI Inflammatory Diseases Summit in Boston (PRNewswire) – Jun 24, 2019 – “Immunic…announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston….Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17….In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.”

 

Entyvio (vedolizumab) / Takeda
Entyvio: Expiry of patents in US in September 2021 and EU in August 2022 (Takeda) – Jun 29, 2019 – Annual Report 2018: Regulatory data protection in EU until May 2024 and US until May 2026; Re-examination period in Japan until July 2026  
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Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan pricing: $30,000/year in US (J.P. Morgan) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67441460; Page no: 17; REPORT TITLE: “Axcella Health Inc- Initiating coverage- Axcella: No Axcella to grind; Initiating at overweight”; AUTHOR: FYE, Jessica, et al; DATE: 06/03/2019

 

Kappaproct (cobitolimod) / InDex
InDex Pharmaceuticals enrolls last patient in phase IIb study CONDUCT with cobitolimod (PRNewswire)- Jun 26, 2019 – P2b, N=215; CONDUCT (NCT03178669); Sponsor: InDex Pharmaceuticals; “InDex Pharmaceuticals…announced that patient enrolment was completed in the dose optimisation study CONDUCT, which is evaluating cobitolimod for the treatment of moderate to severe ulcerative colitis. Top line results are expected to be available in 8-10 weeks.”

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Weekly Top News – IBD – June 24, 2019

June 24, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib launch estimate: 2023/2024 for Crohn’s disease in US/EU (J.P. Morgan) – Jun 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67468537; Page no: 4; REPORT TITLE: “Galapagos NV: Filgotinib US filing scenario analysis suggests balanced risk/ reward into FDA pre-filing discussions”; AUTHOR: Quigley, James, et al; DATE: 06/09/2019

 

etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jun 24, 2019 – P3; N=330; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

etrasimod (APD334) / Arena
Etrasimod launch estimate: 2022 for ulcerative colitis (RBC Capital Markets (Canada)) – Jun 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67280044; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals, Inc. – Q1:19 post-call: Etras’ Ph3 takes focus with ARNA estimates a year ahead of ours”; AUTHOR: Mackay, Kennen, et al; DATE: 05/08/2019

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals announces first subject dosed in ELEVATE UC 52 global phase 3 trial evaluating etrasimod in ulcerative colitis (Arena Press Release) – Jun 17, 2019 – “Arena…today announced that the first subject has been dosed in ELEVATE UC 52, the first of two pivotal trials within the Phase 3 ELEVATE UC registrational program evaluating etrasimod 2 mg in subjects with moderately to severely active ulcerative colitis (UC). ELEVATE UC 52 is a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance.”

 

Entyvio SC (vedolizumab SC) / Takeda
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn’s Disease (clinicaltrials.gov) – Jun 17, 2019 – P3; N=644; Completed; Sponsor: Takeda; Active, not recruiting –> Completed; Trial completion date: Dec 2019 –> May 2019

 

vidofludimus (IMU-838) / Immunic
Immunic, Inc. to present previously unpublished data regarding lead program, IMU-838, at the GI Inflammatory Diseases Summit in Boston (PRNewswire) – Jun 24, 2019 – “Immunic…announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston….Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17….In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.”

Read More …

Weekly Top News – IBD – June 17, 2019

June 17, 2019

Entyvio (vedolizumab) / Takeda
Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis (clinicaltrialsregister.eu) – Jun 16, 2019 – P3; N=292; Sponsor: Takeda

 

Entyvio (vedolizumab) / Takeda
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn’s Disease (clinicaltrials.gov) – Jun 12, 2019 – P3; N=157; Completed; Sponsor: Takeda; Active, not recruiting –> Completed

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $150M in H2 2019 (Zacks) – Jun 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67443474; Page no: 6; REPORT TITLE: “AbbVie Inc.(ABBV) Zacks Company report”; AUTHOR: Research Department; DATE: 06/03/2019

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz US sales projection: $2.7B in 2024 (Infinata) – Jun 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 67021619; Page no: 10; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 06/03/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira sales projection: Guidance of $21B in 2020 (Credit Suisse) – Jun 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67443417; Page no: 16; REPORT TITLE: “US Pharmaceuticals industry overview – June 2019”; AUTHOR: Divan, Vamil, et al; DATE: 06/03/2019

 

ozanimod (RPC1063) / Celgene
Ozanimod sales projection: $1.8B (consensus: $1.3B) by 2023 (Barclays) – Jun 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458401; Page no: 1; REPORT TITLE: “CELG/BMY – Thoughts on Ozanimod NDA acceptance”; AUTHOR: Meacham, Geoffrey, et al; DATE: 06/06/2019

 

Perianal Fistula (PAF) Validation and Burden of Illness Study (clinicaltrials.gov) – Jun 12, 2019 – P; N=600; Not yet recruiting; Sponsor: Takeda

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Weekly Top News – IBD – June 10, 2019

June 10, 2019

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Primary data from study 1 of P3 trial (NCT03440372) for moderate to severe Crohn’s disease in mid-2020 (Credit Suisse) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407582; Page no: 8; REPORT TITLE: “BMY: Conversation evolving on “Brist-ene”, but we remain on the sidelines”; AUTHOR: Divan, Vamil, et al; DATE: 05/29/2019

 

ozanimod (RPC1063) / Celgene
Ozanimod exclusivity expiry: 2034 (Credit Suisse) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407582; Page no: 9; REPORT TITLE: “BMY: Conversation evolving on “Brist-ene”, but we remain on the sidelines”; AUTHOR: Divan, Vamil, et al; DATE: 05/29/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira sales projection: Guidance of $21B in 2020 (Credit Suisse) – Jun 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67443417; Page no: 16; REPORT TITLE: “US Pharmaceuticals industry overview – June 2019”; AUTHOR: Divan, Vamil, et al; DATE: 06/03/2019

 

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) – Jun 7, 2019 – P2; N=40; Recruiting; Sponsor: AbbVie; N=68 –> 40

 

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Primary data from P3 trial (NCT03464097) for moderate to severe Crohn’s disease in mid-to-late 2021 (Credit Suisse) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407582; Page no: 8; REPORT TITLE: “BMY: Conversation evolving on “Brist-ene”, but we remain on the sidelines”; AUTHOR: Divan, Vamil, et al; DATE: 05/29/2019

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Weekly Top News – IBD – June 3, 2019

June 3, 2019

Cosentyx (secukinumab) / Novartis
LONG-TERM EVALUATION OF SECUKINUMAB 150 MG IN ANKYLOSING SPONDYLITIS: 5-YEAR END-OF-STUDY EFFICACY AND SAFETY RESULTS FROM A PHASE 3 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #FRI0379; Pres time: Jun 14, 2019; 01:00 PM – 01:10 PM; Location: Poster area (Hall 10); P3; “Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in pts with AS through 5 years of treatment. The safety profile of secukinumab remained consistent with previous reports. 1–3”

 

Cosentyx (secukinumab) / Novartis
SECUKINUMAB PROVIDES SUSTAINED IMPROVEMENTS IN THE SIGNS AND SYMPTOMS IN PSORIATIC ARTHRITIS: FINAL 5 YEAR EFFICACY AND SAFETY RESULTS FROM A PHASE 3 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #FRI0451; Pres time: Jun 14, 2019; P3; “SEC provided sustained improvements in the signs and symptoms in the major clinical domains of PsA through 5 years. SEC was well tolerated with a safety profile consistent with that previously reported.”

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Launch of Simponi subcutaneous injection 50 mg autoinjector (Mitsubishi Tanabe Press Release) – May 29, 2019 – “Mitsubishi Tanabe Pharma…announced today the launch of SIMPONI® Subcutaneous Injection 50 mg Autoinjector…in Japan.”

 

Cimzia (certolizumab pegol) / Astellas, Dermira, UCB; Humira (adalimumab) / Eisai, AbbVie
THE IMPACT OF EXTRA-ARTICULAR MANIFESTATIONS ON THE CHOICE OF TNF INHIBITOR IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS IN THE BSRBR-AS REGISTER (EULAR 2019) – May 27, 2019 – Abstract #OP0233; Pres time: Jun 14, 2019; 10:40 AM – 10:50 AM; Location: Hall 7A; ” First-line biologic data was available for 441 patients, compromising of 284 (64.4%) adalimumab (ADA), 109 (24,7%) etanercept (ETA) and 48 (10.9%) certolizumab (CZP). EAMs appear to play an important role in the choice of TNFi in axSpA. Patients with previous AAU and IBD are more likely to be prescribed ADA and less likely to receive ETA, consistent with the superior efficacy of monoclonal TNFi for these conditions. The presence or absence of EAMS did not influence the use of CZP, although small sample size might explain the lack of associations.”

 

Humira (adalimumab) / Eisai, AbbVie; Remicade (infliximab) / Mitsubishi Tanabe, J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
EXPERIENCE IN THE USUAL PRACTICE OF PATIENTS WITH BEHÇET’S DISEASE WHO ARE IN FOLLOW-UP IN THE UVEITIS UNIT OF THE DONOSTIA UNIVERSITY HOSPITAL (EULAR 2019) – May 27, 2019 – Abstract #AB0625; “The immunosuppressant’s sought were methotrexate (MTX), azathioprine (AZA), tacrolimus, sulfasalazine (SSZ), cyclosporine (CsA), leflunomide (LFN), cyclophosphamide (CFM); adalimumab (ADA); infliximab (IFX), golimumab (GLM), intravenous immunoglobulins (IVIG). We observed an improvement in VA during the follow-up of these patients compared to VA at the beginning; 70% of patients continued with immunosuppressive treatment with good control of the disease at more than 85 months of follow-up.”

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn’s Disease (clinicaltrials.gov) – May 31, 2019 – P3; N=215; Active, not recruiting; Sponsor: Takeda; Recruiting –> Active, not recruiting; Trial completion date: Apr 2020 –> Aug 2020; Trial primary completion date: Jan 2020 –> Apr 2020

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Weekly Top News – IBD – May 27, 2019

May 27, 2019

etrasimod (APD334) / Arena
Etrasimod: “Etrasimod 2 mg induced significantly higher rates of endoscopic improvement, histologic improvement and remission, and mucosal healing”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
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etrasimod (APD334) / Arena
Etrasimod: “Patients who received etrasimod 2 mg exhibited significant decreases in both fecal calprotectin and C-reactive protein versus placebo”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
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brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrials.gov) – May 23, 2019 – P3; N=1000; Not yet recruiting; Sponsor: Allergan

 

Entyvio (vedolizumab) / Takeda
Entyvio (vedolizumab) approved in Japan for the treatment of patients with moderately to severely active Crohn’s disease (Takeda Press Release) – May 22, 2019 – “Takeda…announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Entyvio…for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan.”

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

mirikizumab (LY3074828) / Eli Lilly
Lilly’s mirikizumab met primary endpoint and key secondary endpoints in phase 2 study, including reductions of gastrointestinal lesions (PRNewswire) – May 21, 2019 – P2, N=180; SERENITY (NCT02891226); Sponsor: Eli Lilly; “Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing….We look forward to initiating Phase 3 trials to further evaluate mirikizumab’s benefit-risk profile for the treatment of Crohn’s disease.”

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P3; N=372; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

 

mirikizumab (LY3074828) / Eli Lilly
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P2; N=240; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
EU regulators slap safety restriction on Pfizer’s Xeljanz (pharmaphorum) – May 20, 2019 – “European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.”

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Weekly Top News – IBD – May 20, 2019

May 20, 2019

etrasimod (APD334) / Arena
ELEVATE UC OLE: An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis(clinicaltrials.gov) – May 15, 2019 – P3; N=702; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Tremfya (guselkumab) / J&J
Tremfya: Regulatory submissions in US/EU for Crohn’s disease and ulcerative colitis between 2019-2023(J&J) – May 16, 2019 – Pharmaceutical Business Review: Regulatory submissions in US/EU for personalized dosing psoriasis between 2019-2023  
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Entyvio (vedolizumab) / Takeda
Entyvio: Regulatory approval in Japan for Crohn’s disease in H1 FY2019 (Takeda) – May 15, 2019 – FY 2018 Results  
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JNJ-64304500 / J&J
JNJ-64304500: Regulatory submissions in US/EU for Crohn’s disease between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review  
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Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Simponi: Regulatory submissions in US/EU for pediatric ulcerative colitis between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review  
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Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104: FDA meeting related to P3 trial design and path to approval in Crohn’s disease in mid-2019(RedHill) – May 16, 2019 – Corporate Presentation  
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PTG-200 / Protagonist Therapeutics, J&J
PTG-200 launch estimate: 2027 (BMO) – May 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67255938; Page no: 8; REPORT TITLE: “Protagonist Therapeutics Inc – Catalyst-rich pipeline highlighted during investor meetings”; AUTHOR: Farmer, George, et al; DATE: 05/06/2019

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

Cyltezo (adalimumab biosimilar) / Boehringer Ingelheim
BI 695501 Versus Humira in Patients With Active Crohn’s Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity (clinicaltrials.gov) – May 15, 2019 – P3; N=147; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Completed

 

Entyvio (vedolizumab) / Takeda
New exploratory data from VARSITY, first head-to-head ulcerative colitis biologic study which demonstrated superiority of vedolizumab to adalimumab in clinical remission at week 52, presented at 2019 Digestive Disease Week (Businesswire) – May 19, 2019 – P3b, N=770; VARSITY (NCT02497469); Sponsor: Takeda; “New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. A separation between the treatment groups was seen as early as week 6, favoring vedolizumab. These results were announced in a Distinguished Abstract Plenary Lecture Presentation at the 2019 Digestive Disease Week…”

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Weekly Top News – IBD – May 13, 2019

May 13, 2019

Remsima SC (infliximab biosimilar SC) / Celltrion
A Phase 3 Study to Evaluate the Efficacy and Safety of the CT-P13 SC in Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – May 10, 2019 – P3; N=600; Not yet recruiting; Sponsor: Celltrion

 

etrasimod (APD334) / Arena
Etrasimod: Initiation of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis by mid-2019 (Arena) – May 11, 2019 – Q1 2019 Results: Data from P3 trial for ulcerative colitis in 2021

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 10, 2019 – P3; N=372; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Entyvio (vedolizumab) / Takeda
A Phase 3 Study of Vedolizumab for Induction and Maintenance Therapy in Japanese Patients with Moderate to Severe Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; P3; “It additionally showed numerically greater clinical remission at Week 60 compared with PBO. VDZ is well-tolerated in induction and maintenance therapy in Japanese pts with moderate to severe CD with a safety profile consistent with non-Japanese studies.”

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Use is Not Associated with Increased Malignancy Incidence: Gemini Long-Term Safety Study Results and Post-Marketing Data (DDW 2019) – May 9, 2019 – Abstract #Su1835; Pres time: May 19, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – San Diego Convention Center; P3; “As observed numbers are small, individual malignancy data should not be over-interpreted, and the limitation that standardization does not correct for other potential confounders (e.g. smoking and body mass index) should be considered. Although limitations of post-marketing safety reports, including incomplete data and voluntary reporting of events, must be considered when interpreting post-marketing data, the number of malignancies with VDZ appeared low.”

 

Entyvio SC (vedolizumab SC) / Takeda
Effects of Subcutaneous Vedolizumab on Health-Related Quality of Life and Work Productivity in Patients with Ulcerative Colitis: Results from the Phase 3 Visible 1 Trial (DDW 2019) – May 9, 2019 – Abstract #Sa1878; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; “Similarly, signifi- cant improvements in work productivity measures were observed among patients treated with vedolizumab SC. Further investigation of the effects of vedolizumab SC on quality of life is needed to validate these findings.”

 

mirikizumab (LY3074828) / Eli Lilly
Efficacy and Safety of Mirikizumab (LY3074828) in a Phase 2 Study of Patients with Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #1003; Pres time: May 21, 2019; 10:00 AM – 10:15 AM; Location: Room: 20BCD – SDCC; P2; “Sustained efficacy and safety are currently being evaluated in a maintenance study. S-216AGA”

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Stelara (ustekinumab) / J&J
STELARA CD PMS: Post-Marketing Surveillance for Crohn’s Disease Participants Treated With Stelara (Ustekinumab) (clinicaltrials.gov) – May 8, 2019 – P; N=600; Recruiting; Sponsor: Janssen Korea, Ltd., Korea

 

Entyvio SC (vedolizumab SC) / Takeda
U.S. Food & Drug Administration accepts Takeda’s Biologics License Application for a subcutaneous formulation of vedolizumab (Entyvio) for maintenance therapy in moderately to severely active ulcerative colitis (Takeda Press Release) – May 9, 2019 – “Takeda…announced that the U.S. Food & Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.”

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