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Category: Inflammatory Bowel Disease

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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Weekly Top News – IBD – May 6, 2019

May 6, 2019

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Data from P2 SERENITY trial (NCT02891226) for Crohn’s disease at DDW (May 18- 21, 2019) (Eli Lilly) – Apr 30, 2019 – Q1 2019 Results
[Screenshot]

 

Stelara (ustekinumab) / J&J
GENERAL HEALTH STATUS IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS RECEIVING USTEKINUMAB: RESULTS FROM THE PHASE 3 UNIFI INDUCTION AND MAINTENANCE STUDIES (DDW 2019) – May 2, 2019 – Abstract #Sa1887; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Stelara (ustekinumab) / J&J
EFFECTS OF USTEKINUMAB INDUCTION THERAPY ON ENDOSCOPIC AND HISTOLOGIC HEALING IN THE UNIFI PHASE 3 STUDY IN ULCERATIVE COLITIS (DDW 2019) – May 3, 2019 – Abstract #Tu1735; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Xeljanz (tofacitinib) / Pfizer
ANALYSIS OF HEMATOLOGICAL CHANGES IN TOFACITINIB-TREATED PATIENTS WITH ULCERATIVE COLITIS ACROSS PHASE 3 INDUCTION AND MAINTENANCE STUDIES (DDW 2019) – May 3, 2019 – Abstract #Tu1752; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Xeljanz (tofacitinib) / Pfizer
MEASURING THE MEDIATING EFFECTS OF MAYO SCORE COMPONENTS FOR TOFACITINIB ON DISEASE-SPECIFIC QUALITY OF LIFE IN ULCERATIVE COLITIS: DATA FROM THE OCTAVE PROGRAM (DDW 2019) – May 2, 2019 – Abstract #Sa1873; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Entyvio (vedolizumab) / Takeda
EFFECTS OF INTRAVENOUS VEDOLIZUMAB ON HEALTH-RELATED QUALITY OF LIFE AND WORK PRODUCTIVITY IN PATIENTS WITH CROHN’S DISEASE: RESULTS FROM THE PHASE 3B VERSIFY TRIAL (DDW 2019) – May 2, 2019 – Abstract #Sa1881; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

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 3, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Alofisel (darvadstrocel) / Takeda
Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei) – Apr 29, 2019 – “Takeda is looking to adopt the pricing mechanism for a stem cell therapy called Alofisel for a complication of Crohn’s disease. Because of the complex production method that involves cell cultivation, the drug is expected to carry a price tag of an estimated 60,000 euros ($67,000)….The drug is expected to go on sale by the end of fiscal 2019 in the U.K. and elsewhere in Europe.”

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Weekly Top News – IBD – April 29, 2019

April 29, 2019

mirikizumab (LY3074828) / Eli Lilly

VIVID-1: A Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Apr 24, 2019 – P3; N=1100; Not yet recruiting; Sponsor: Eli Lilly and Company
Clinical • New P3 trial

 

amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health

Salix enters into exclusive license agreement with Mitsubishi Tanabe Pharma to develop and commercialize late stage investigational S1P modulator for the treatment of inflammatory bowel disease (PRNewswire) – Apr 25, 2019 – “Salix Pharmaceuticals…announced today that its affiliate has entered into an exclusive licensing agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) (TSE: 4508) to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate (S1P) receptor that plays a role in autoimmune diseases, such as Inflammatory Bowel Disease (IBD) and ulcerative colitis.”
Licensing / partnership

 

Alofisel (darvadstrocel) / Takeda

Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei) – Apr 29, 2019 – “Takeda is looking to adopt the pricing mechanism for a stem cell therapy called Alofisel for a complication of Crohn’s disease. Because of the complex production method that involves cell cultivation, the drug is expected to carry a price tag of an estimated 60,000 euros ($67,000)….The drug is expected to go on sale by the end of fiscal 2019 in the U.K. and elsewhere in Europe.”
Commercial • Pricing

 

Entyvio (vedolizumab) / Takeda

DEVELOPMENT AND VALIDATION OF A CLINICAL SCORING TOOL FOR PREDICTING TREATMENT OUTCOMES WITH VEDOLIZUMAB IN PATIENTS WITH ULCERATIVE COLITIS (DDW 2019) – Apr 24, 2019 – Abstract #334; Pres time: May 19, 2019; 10:15 AM – 10:30 AM; Location: Room: 30 – San Diego Convention Center; No abstract available.
Clinical

 

Humira (adalimumab) / Eisai, AbbVie

Drug Induced Renal Granulomatous Disease – poor outcone of a rare clinical condition (NKF-CSM 2019) – Apr 23, 2019 – Abstract #166; “…We report such a case of granulomatous interstitial nephritis in a patient with Crohn’s disease after being treated with Adalimumab for 8 months…She was treated with prednisone 1 mg/kg/day, however renal function continued to decline and dialysis was initiated as inpatient…Renal recovery following such insults have been historically mixed, even with appropriate use of steroids. As such, TNF-α inhibitors should be used with caution with frequent monitoring of kidney function.”
Clinical

 

Entyvio (vedolizumab) / Takeda

VEDOLIZUMAB TARGETS LYMPHOID AGGREGATES IN THE GASTROINTESTINAL TRACT OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE, REFLECTED BY A DRAMATIC DROP IN GUT-HOMING PLASMABLASTS IN CIRCULATION (DDW 2019) – Apr 24, 2019 – Abstract #335; Pres time: May 19, 2019; 10:30 AM – 10:45 AM; Location: Room: 30 – San Diego Convention Center; No abstract available.
Clinical

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J

EARLY INFLIXIMAB PHARMACOKINETICS AND WEEK ONE CLINICAL RESPONSE IN PEDIATRIC ACUTE SEVERE ULCERATIVE COLITIS: THE ARCH STUDY (DDW 2019) – Apr 24, 2019 – Abstract #235; Pres time: May 19, 2019; 08:25 AM – 08:35 AM; Location: Room: 31BC – San Diego Convention Center; No abstract available.
Clinical • PK/PD data

 

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Weekly Top News – IBD – April 22, 2019

April 22, 2019

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission for ulcerative colitis in US in 2021 (Roche) – Apr 17, 2019 – Q1 2019 Results: Regulatory submission for ulcerative colitis in EU in 2021; Regulatory submissions for Crohn’s disease in US and EU in 2022 or later
BLA • European regulatory
[Screenshot]

 

TD-1473 / J&J
TD-1473 clinical estimate: Data from P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in 2020 (Cantor Fitzgerald) – Apr 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67081612; Page no: 1; REPORT TITLE: “Theravancer Biopharma Inc – Don’t get JAK’d, invest in the right one”; AUTHOR: Research Department; DATE: 04/09/2019
P2/3 data

 

TD-1473 / J&J
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) – Apr 18, 2019 – P2/3; N=500; Not yet recruiting; Sponsor: Theravance Biopharma
Clinical • New P2/3 trial

 

ozanimod (RPC1063) / Celgene
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Apr 16, 2019 – P2/3; N=195; Not yet recruiting; Sponsor: Celgene
Clinical • New P2/3 trial

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2 Divergence2 trial (NCT03077412) for Crohn’s disease in mid-2019 (RBC Capital Markets (Canada)) – Apr 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67047741; Page no: 2; REPORT TITLE: “Galapagos NV – Takeaways from the road: High aspirations following FINCH data”; AUTHOR: Abrahams, Brian, et al; DATE: 04/04/2019
P2 data

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2 trial (NCT03046056) for small bowel Crohn’s disease in mid-2019 (RBC Capital Markets (Canada)) – Apr 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67047741; Page no: 2; REPORT TITLE: “Galapagos NV – Takeaways from the road: High aspirations following FINCH data”; AUTHOR: Abrahams, Brian, et al; DATE: 04/04/2019
P2 data

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Expanded Access to Risankizumab (clinicaltrials.gov) – Apr 16, 2019 – P; N=N/A; Available; Sponsor: AbbVie
New trial

 

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Weekly Top News – IBD – April 9, 2019

April 9, 2019

Idacio (adalimumab biosimilar) / Fresenius Kabi
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio (Fresenius Kabi Press Release) – Apr 3, 2019 – “Fresenius Kabi…announced today that the European Commission (EC) granted marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.”
European regulatory

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 US launch estimate: 2023 (H.C. Wainwright & Co) – Apr 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 66838015; Page no: 1; REPORT TITLE: “RedHill Biopharma Ltd.- Focus on Talicia; Adjusting PT to $16.00 on changes to RHB-104 outlook; Reiterate buy”; AUTHOR: Ramakanth, Swayampakula, et al; DATE: 02/27/2019
Launch US

 

Entyvio SC (vedolizumab SC) / Takeda
European Medicines Agency accepts Takeda’s Marketing Authorization application for a subcutaneous formulation of vedolizumab for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s Disease (Businesswire) – Apr 1, 2019 – “Takeda…announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for 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 pre-filled syringe and pen options.”
European regulatory

 

Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion completes FDA application for phase 3 trial of Remsima SC (Yonhap News Agency) – Apr 1, 2019 – “South Korea’s leading biopharmaceutical firm Celltrion announced Monday that it has completed the U.S. Food and Drug Administration’s investigational new drug (IND) application for Remsima SC….Celltrion plans to further expand its phase 3 clinical trials of Remsima SC to other countries with the aim to win U.S. FDA approval by 2020….Remsima SC will be under patent protection until 2037…”
BLA • IND • Patent

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Prescription of antibiotics for adults with acute diarrhoeal infections in Korea: a population-based study (ECCMID 2019) – Apr 5, 2019 – Abstract #P2034; Pres time: Apr 15, 2019; 01:30 PM – 02:30 PM; “…The antibiotics most frequently prescribed for both monotherapy and combination regimens in patients with ADI were fluoroquinolones (29.80%), rifaximin (26.82%), second-generation cephalosporins (9.21%), third-generation cephalosporins (7.25%), trimethoprim/sulfamethoxazole (5.54%), and ß-lactam/ß-lactamase inhibitors (5.30%)… This study revealed differences between the antibiotics used to treat ADI in Korea and those recommended by the guidelines for treatment of ADI. Multifaceted efforts are necessary to strengthen physicians’ adherence to the published guidelines.”
Clinical

 

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