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Category: Inflammatory Bowel Disease

Weekly Top News – IBD – September 9, 2019

September 9, 2019

Stelara (ustekinumab) / J&J
European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union (Businesswire) – Sep 4, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies….The EC approval is based on data from the pivotal Phase 3 UNIFI trial programme…”

 

Otezla (apremilast) / Amgen
Otezla patent expiry: February 2028 (CFRA) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67874668; Page no: 5; REPORT TITLE: “Amgen Inc”; AUTHOR: Huang, Kevin, et al; DATE: 08/26/2019

 

Entyvio SC (vedolizumab SC) / Takeda; Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer; Entyvio (vedolizumab) / Takeda; Humira (adalimumab) / Eisai, AbbVie; Stelara (ustekinumab) / J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J; Xeljanz (tofacitinib) / Pfizer; Remicade (infliximab) / Mitsubishi Tanabe, J&J
ICER to assess treatments for ulcerative colitis (Institute for Clinical and Economic Review) – Sep 6, 2019 – “The Institute for Clinical and Economic Review (ICER) announced today that it plans to assess the comparative clinical effectiveness and value of therapies for ulcerative colitis (UC), including: Vedolizumab (Entyvio®, Takeda), subcutaneous and IV formulations, Infliximab (Remicade®, Janssen), Infliximab-dyyb (Inflectra®, Pfizer), Adalimumab (Humira®, AbbVie), Golimumab (Simponi®, Janssen), Tofacitinib (Xeljanz®, Ustekinumab (Stelara®, Janssen)….A draft scoping document, which will provide more detail on ICER’s planned analysis, will be available on September 27, 2019. That document will be open to public comment for three weeks.”

 

Otezla (apremilast) / Amgen
Otezla WW sales projection: $3.1B (US: $2.5B) peak in 2028 (RBC Capital Markets (Canada)) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873985; Page no: 3; REPORT TITLE: “Amgen Inc. – Thesis-changing M&A comes at a high cost: Otezla acquisition adds +$14/sh to PT”; AUTHOR: Mackay, Kennen, et al; DATE: 08/26/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi WW sales projection: $300M in FY2019 and $800M in FY2020 (Piper Jaffray) – Sep 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67909429; Page no: 1; REPORT TITLE: “Abbvie Inc – Skyrizi En Fuego – New derm survey indicates Q219 was no fluke”; AUTHOR: Raymond, Christopher, et al; DATE: 09/04/2019

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Weekly Top News – IBD – September 2, 2019

September 2, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Credit Suisse) – Aug 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67836161; Page no: 1; REPORT TITLE: “VIDEO – US biotech week in review (8/16)”; AUTHOR: Research Department; DATE: 08/16/2019

 

Otezla (apremilast) / Amgen
Bristol-Myers Squibb announces agreement between Celgene and Amgen to divest Otezla for $13.4 billion (Businesswire) – Aug 26, 2019 – “Bristol-Myers Squibb Company…announced today that Celgene Corporation…has entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast) for $13.4 billion in cash….The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC)…’establishing OTEZLA as an important medicine for patients with psoriasis, psoriatic arthritis and Behçet’s Disease’…Bristol-Myers Squibb now expects the pending merger with Celgene to close by the end of 2019.”

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq sales projection: $5B (previously $3B) peak (SVB Leerink) – Aug 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838026; Page no: 1; REPORT TITLE: “Upa gets class, but not product thrombosis labelling; P/T $91”; AUTHOR: Porges, Geoffrey, et al; DATE: 08/18/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq US sales projection: $60M in Q3 2019 and $232M in FY2019 (UBS) – Aug 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67834016; Page no: 1; REPORT TITLE: “AbbVie Inc- First read: AbbVie “Weekly Skyrizi tracker” (Neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 08/16/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan sales projection: $1.3B in 2019 (Barclays) – Aug 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 67590552; Page no: 1; REPORT TITLE: “Bausch Health Companies Inc – Bausch Health Companies: Fundamentals continue to strengthen; Stay OW”; AUTHOR: Prasad, Balaji, et al; DATE: 07/08/2019

 

AEVI-002 / Sanofi, Aevi Genomic, Kyowa Hakko Kirin
AEVI-002: Initial data from P1 trial (NCT03169894) for crohn’s disease in H2 2019 (Aevi Genomic Medicine) – Aug 27, 2019 – Corporate Presentation  
[Screenshot]

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan sales projection: $1,338M in 2019 (BTIG) – Aug 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 66633408; Page no: 1; REPORT TITLE: “Bausch Health Companies – Xifaxan beat offsets more weakness in ortho derm; Will Duobrii be a meaningful contributor in 2H19?”; AUTHOR: Chiang, Timothy, et al; DATE: 08/07/2019

 

Kappaproct (cobitolimod) / InDex
InDex Pharmaceuticals meets primary endpoint in the phase IIb study CONDUCT with cobitolimod in ulcerative colitis (BioSpace) – Aug 27, 2019 – P2, N=213; CONDUCT (NCT03178669); Sponsor: InDex; “The study met the primary endpoint of clinical remission, demonstrating a superior efficacy of 15% (delta) in patients receiving the highest dose of cobitolimod compared to placebo. Cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo.”

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Weekly Top News – IBD – August 26, 2019

August 26, 2019

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in H2 2021 (Wells Fargo) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67741783; Page no: 2; REPORT TITLE: “Update from San Francisco biotech access day”; AUTHOR: Research Department; DATE: 08/02/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 clinical trial estimate: Initiation of P3 trial for Crohn’s disease in Q1 2020(Ladenburg, Thalmann) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67673924; Page no: 1; REPORT TITLE: “Redhill Biopharma Ltd 2Q19 results; Talica PDUFA November 2, 2019; Buy and $24 PT”; AUTHOR: Kaplan, Matthew, et al; DATE: 07/24/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NICE’s fast-track catapults Skyrizi into market (PMLive) – Aug 21, 2019 – “NICE has published a final recommendation for AbbVie and Boehringer Ingelheim’s Skyrizi today, completing a fast-track process which will see the new psoriasis treatment gain market access in record time….Accelerates the review process and also cuts the standard 90 day implementation period down to 30 days. This means the NHS across England has a month from today to make preparations for prescribing of Skyrizi to begin….SVB Leerink analyst Geoffrey Porges predicts $3bn in peak sales for AbbVie’s Skyrizi, with its success dependent on how it will fare not just in psoriasis but the other hotly-contested inflammation and immunology indications as well, such as Crohn’s and ulcerative colitis.”

 

Otezla (apremilast) / Celgene
Bristol-Myers Squibb announces agreement between Celgene and Amgen to divest Otezla for $13.4 billion (Businesswire) – Aug 26, 2019 – “Bristol-Myers Squibb Company…announced today that Celgene Corporation…has entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast) for $13.4 billion in cash….The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC)…’establishing OTEZLA as an important medicine for patients with psoriasis, psoriatic arthritis and Behçet’s Disease’…Bristol-Myers Squibb now expects the pending merger with Celgene to close by the end of 2019.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira pricing: Wholesale acquisition cost of $57,000/year (UBS) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67836265; Page no: 1; REPORT TITLE: “AbbVie Inc- First read: AbbVie “Upadacitinib approval mostly in-line w/ expectations””; AUTHOR: Jacob, Navin, et al; DATE: 08/16/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira patent expiry: 2022 (NH Inv.) – Aug 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 67851543; Page no: 21; REPORT TITLE: “Medy Tox Inc – Initiating coverage – Medytox-Ready to cross the great wall-08/21/2019”; AUTHOR: Ra, Ryan, et al; DATE: 08/21/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 patent expiry: 2019-2038 (Ladenburg, Thalmann) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67570515; Page no: 8; REPORT TITLE: “Redhill Biopharma Ltd Priority review for Talicia (RHB-105); PDUFA November 2, 2019; Buy and $24 PT”; AUTHOR: Kaplan, Matthew, et al; DATE: 07/03/2019

 

etrasimod (APD334) / Arena
Etrasimod share value projection: $56/share to Arena Pharmaceutical (RBC Capital Markets (Canada)) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67780220; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals, Inc. – Q2:19 post-call: ARNA clinical execution continues with trials fully funded”; AUTHOR: Mackay, Kenen, et al; DATE: 08/07/2019

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200 share value projection: $4.50/share to Protagonist Therapeutics (H.C. Wainwright & Co) – Aug 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67785243; Page no: 2; REPORT TITLE: “Protagonist Therapeutics Inc – PTG-300 broadens its horizons; Reiterate Buy”; AUTHOR: Research Department; DATE: 08/08/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 share value projection: $9/share to RedHill (Roth Capital) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67668922; Page no: 2; REPORT TITLE: “Redhill Biopharma Ltd RDHL: 2Q19 Recap – Focus on Talicia (PDUFA Nov 2)”; AUTHOR: Henry, Scott, et al; DATE: 07/23/2019

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Weekly Top News – IBD – August 12, 2019

August 12, 2019

Stelara (ustekinumab) / J&J
Ustekinumab Improved Work Productivity in Patients With Moderate to Severe Ulcerative Colitis: Results From the Phase 3 UNIFI Induction and Maintenance Studies (ACG 2019) – Aug 8, 2019 – Abstract #P1393; Pres time: Oct 28, 2019; 10:30 AM – 04:15 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline, patients had a mean percent work time missed ranging from 17.7% to 19.3%, impairment while working from 39.1% to 45.3%, overall work impairment from 43.7% to 49.1%, and activity impairment from 51.8% to 52.8%. At Wk8, patients who received UST IV had significantly greater improvement in WPAI domains and daily productivity VAS compared with PBO (Table). In the maintenance study, UST-treated patients generally maintained or numerically improved WPAI scores, while scores for patients in the PBO group worsened.”

 

Stelara (ustekinumab) / J&J
Effects of Ustekinumab Maintenance Therapy on Endoscopic Improvement and Histologic Improvement in the UNIFI Phase 3 Study in Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #56; Pres time: Oct 30, 2019; 08:40 AM – 08:50 AM; Location: Stars at Night Ballroom – B2; “At maintenance Week 44, EI was achieved in 28.6%, 43.6%, and 51.1% of pts treated with placebo, UST q12w (p=0.002 vs placebo), and UST q8w (p< 0.001), respectively. HI was achieved at Week 44 in 32.9%, 54.0%, and 59.3% of pts treated with placebo, UST q12w, and UST q8w, respectively (p< 0.001 for both q12w and q8w). MH was achieved at Week 44 in 24.1%, 38.8%, and 45.9% of pts treated with placebo, UST q12w (p=0.002), and UST q8w (p,0.001), respectively.”

 

Stelara (ustekinumab) / J&J
Molecular Response to Ustekinumab in Moderate-to-Severe Ulcerative Colitis by Serum Protein and Colon Transcriptomic Analysis: Results From the UNIFI Phase 3 Maintenance Study (ACG 2019) – Aug 8, 2019 – Abstract #P0454; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At Wk44 after the start of maintenance therapy, expression of colonic genes dysregulated in UC was altered towards normal levels in all treatment groups, with the greatest improvements among those receiving UST and those in clinical remission (p< 0.05 for Wk44 versus start of maintenance). No dose effect was observed between q8w and q12w UST doses, and no significant improvements in disease signature occurred in non-responders to placebo or UST. UST maintenance therapy magnified the normalization of serum proteins following UST induction; among pts receiving q8w UST who were in remission at Wk44, the proteins IFNγ, IL-17A, MMP3, and SAA reached concentrations comparable to those seen in healthy controls.”

 

Stelara (ustekinumab) / J&J
Safety of Ustekinumab in Inflammatory Bowel Diseases: Integrated Safety Analysis of Results From Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #P0505; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline (2370 pts in pooled phase 3 IBD studies), median age was 38.0 years, 46.9% were receiving corticosteroids, 30.8% were receiving IMM, 53.0% had failed biologics, and 37.1% were naïve to biologics. In phase 3 IBD studies, through Wk8 of PBO-controlled induction, the frequency of key safety events was similar between UST and PBO (Table 1). In addition, through 1 year across phase 2/3 IBD studies (Table 2), numbers of pts per 100 PY with key safety events were similar between treatment groups.”

 

Entyvio SC (vedolizumab SC) / Takeda
Takeda submits New Drug Application for a subcutaneous formulation of vedolizumab for patients with moderately to severely active ulcerative colitis in Japan (Takeda Press Release) – Aug 8, 2019 – “Takeda…announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.”

 

PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics reports second quarter 2019 financial results (PRNewswire) – Aug 7, 2019 – “Protagonist and Janssen are jointly conducting the development of PTG-200 through completion of a Phase 2 proof-of-concept study in Crohn’s disease. Protagonist and Janssen Biotech completed the filing of a U.S. Investigational New Drug (IND) application to support the global Phase 2 clinical study with initiation expected in the fourth quarter of 2019.”

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Weekly Top News – IBD – August 5, 2019

August 5, 2019

Remsima SC (infliximab biosimilar SC) / Celltrion
Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn’s disease (clinicaltrialsregister.eu) – Aug 1, 2019 – P3; N=600; Ongoing; Sponsor: Celltrion, Inc

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P3 Diversity1 trial (NCT02914561) for Crohn’s disease in December 2019 (Oppenheimer) – Aug 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67660525; Page no: 2; REPORT TITLE: “Gilead Sciences Inc.: New CEO prepping for growth”; AUTHOR: Research Department; DATE: 07/22/2019

 

TD-1473 / J&J
Theravance Biopharma, Inc. reports second quarter 2019 financial results and provides business update (BioSpace) – Jul 31, 2019 – “Program Updates: TD-1473: Registrational Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn’s disease (DIONE) progressing. Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn’s disease studies planned late-2020.”

 

Xeljanz (tofacitinib) / Pfizer
Pfizer reports second-quarter 2019 results (BioSpace) – Jul 29, 2019 – “Xeljanz globally, up 36% operationally, driven by: 103% operational growth in international markets…and 21% growth in the U.S., reflecting volume growth from the launches of the UC and psoriatic arthritis (PsA) indications as well as continued growth in the RA indication…partially offset primarily by lower revenues for: Enbrel internationally, down 16% operationally, primarily reflecting continued biosimilar competition in most developed Europe markets as well as the unfavorable impact of timing of government purchases in certain emerging markets…”

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: Guidance of $4-5B peak (Wells Fargo) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67660211; Page no: 1; REPORT TITLE: “Morphic Holding- Initiating coverage – MORF: Initiating at Outperform on oral integrin platform”; AUTHOR: Research Department; DATE: 07/22/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Completion of enrollment in P3 DIVERSITY trial (NCT02914561) for Crohn’s disease in Q3 2020 (Gilead) – Jul 31, 2019 – Q2 2019 Results

 

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Weekly Top News – IBD – July 29, 2019

July 30, 2019

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 HICKORY trial (NCT02100696) for ulcerative colitis in Q4 2019 (Barclays) – Jul 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67625398; Page no: 117; REPORT TITLE: “European Pharmaceuticals: The weekly check-up”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 07/15/2019

 

mirikizumab (LY3074828) / Eli Lilly
Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn’s Disease(clinicaltrialsregister.eu) – Jul 23, 2019 – P3; N=1100; Ongoing; Sponsor: Eli Lilly and Company

 

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission in US for ulcerative colitis in 2020 (Roche) – Jul 26, 2019 – H1 2019 results: Regulatory submission in EU for ulcerative colitis in 2020  
[Screenshot]

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Cantor Fitzgerald) – Jul 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67562661; Page no: 1; REPORT TITLE: “Galapagos NV – The ball is back in GLPG’s court; FDA update lifts key overhang”; AUTHOR: Research Department; DATE: 07/02/2019

 

Stelara (ustekinumab) / J&J
Janssen receives CHMP positive opinion for Stelara (ustekinumab) recommending approval for the treatment of moderately to severely active ulcerative colitis in the EU (Businesswire) – Jul 26, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorisation in the European Union (EU) for the use of ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies….The CHMP adopted the opinion based on data from the pivotal Phase 3 UNIFI trial programme…Following this positive opinion, a final decision from the European Commission (EC) regarding its marketing authorisation is expected later this year.”

 

etrolizumab (RG7413) / Roche
Etrolizumab regulatory estimate: Approval for IBD in 2021 (Jefferies) – Jul 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67604423; Page no: 25; REPORT TITLE: “Astrazeneca: Pharma Quarterly: Stock catalysts, models & valuation”; AUTHOR: Welford, Peter, et al; DATE: 07/10/2019

 

Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung
FDA approves Samsung Bioepis’ Hadlima (adalimumab-bwwd) (Businesswire) – Jul 24, 2019 – “Samsung Bioepis…announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.”

 

Entyvio SC (vedolizumab SC) / Takeda
Investigational subcutaneous formulation of vedolizumab meets primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active Crohn’s disease(Businesswire) – Jul 22, 2019 – P3, N=644; VISIBLE 2 (NCT02611817); Sponsor: Takeda; “In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50. Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.”

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz, Xeljanz XR (tofacitinib): Drug safety communication – due to an increased risk of blood clots and death with higher dose (EIN News) – Jul 26, 2019 – “FDA has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA)…”

 

VE-202 / J&J, Vedanta Biosciences
VE-202: PK/PD data from P1 trial in healthy subjects in 2019 (Puretech) – Jul 26, 2019 – Corporate Presentation  
[Screenshot]

 

cannabidiol solution (ST-SDCD-01) / STERO Biotechs
Stero Biotechs to commence phase 2a clinical trial of cannabidiol-based formulation for patients with Crohn’s disease (PRNewswire) – Jul 23, 2019 – “Stero Biotechs…received its second Helsinki approval to move forward with a second Phase 2a clinical trial. The trial will be a randomized, double-blind, placebo-controlled, multicenter study of ST-SDCD-01, a CBD based solution in an effort to lower the steroid dosage in patients with Steroid Dependent Crohn’s Disease (SDCD).”

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Weekly Top News – IBD – July 22, 2019

July 22, 2019

Stelara (ustekinumab) / J&J
Stelara: Regulatory approval in US for ulcerative colitis in 2019 (J&J) – Jul 16, 2019 – Key 2019 Events  
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab clinical trial estimate: First data from P3 trials LUCENT 1 (NCT03518086), LUCENT 2 (NCT03524092) and LUCENT 3 (NCT03519945) for ulcerative colitis in 2021(Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 318; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Stelara (ustekinumab) / J&J
Stelara regulatory estimate: Approval for ulcerative colitis in H2 2019 (Wells Fargo) – Jul 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 67590167; Page no: 6; REPORT TITLE: “Johnson & Johnson – JNJ: 2Q19 preview & US pharma tracker”; AUTHOR: Biegelsen, Lawrence, et al; DATE: 07/07/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi clinical trial estimate: Primary completion of P3 trial (NCT03104413) for Crohn’s disease in June 2020 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 67; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Entyvio SC (vedolizumab SC) / Takeda
Investigational subcutaneous formulation of vedolizumab meets primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active Crohn’s disease(Businesswire) – Jul 22, 2019 – P3, N=644; VISIBLE 2 (NCT02611817); Sponsor: Takeda; “In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50. Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.”

 

upadacitinib (ABT-494) / AbbVie
Upadacitinib clinical trial estimate: Primary completion of P3 SELECT-GCA trial (NCT03725202) for giant cell arteritis in March 2022 (Cowen & Co) – Jul 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 55; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

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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  
[Screenshot]

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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  
[Screenshot]

 

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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