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Category: Psoriasis

Weekly Top News – Psoriasis – June 10, 2019

June 10, 2019

pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – Jun 9, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Taltz (ixekizumab) / Eli Lilly
Lilly to present new data and commitment to patient-centered solutions at the Annual European Congress of Rheumatology (Eli Lilly Press Release) – Jun 6, 2019 – “Eli Lilly…will present data for Taltz® (ixekizumab) and Olumiant® (baricitinib) at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid from June 12-15, 2019….The data include clinical studies of Taltz in the treatment of patients with psoriatic arthritis…Lilly will share in a late-breaking oral presentation the detailed results from the SPIRIT-H2H study…”

 

mirikizumab (LY3074828) / Eli Lilly; Taltz (ixekizumab) / Eli Lilly
Lilly to showcase scientific innovation within dermatology portfolio at 24th World Congress of Dermatology (Eli Lilly Press Release) – Jun 5, 2019 – “Eli Lilly and Company…will present data for Taltz (ixekizumab)…mirikizumab at the 24th World Congress of Dermatology (WCD) taking place June 10-15, 2019 in Milan, Italy….The data include 11 abstracts reflecting clinical studies of Taltz…Lilly will share short- and long-term health outcomes data, as well as long-term data on efficacy in patients with scalp psoriasis, from the Phase 2 clinical program of its investigational medicine mirkizumab for the treatment of moderate-to-severe plaque psoriasis.”

 

Tremfya (guselkumab) / J&J
Tremfya pricing: Average retail price of $11,800/1ml in US and €12,000/1ml in Portugal (Infinata) – Jun 7, 2019 – A subscription to Thomson ONE is required to gain full access to report 67022679; Page no: 14; REPORT TITLE: “AbbVie Inc. – Company Report”; AUTHORInfinata, et al; DATE: 06/03/2019

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite participating in one-on-one partnering meetings at the BIO International Convention on June 3-6, 2019 (Can-Fite Biopharma Press Release) – Jun 4, 2019 – “Can-Fite BioPharma…announced today that the Company’s VP of Business Development, Sari Fishman, is conducting one-on-one meetings with pharmaceutical companies for potential distribution and partnerships for the Company’s drug candidates, Piclidenoson and Namodenoson, at the BIO International Convention 2019 on June 3-6, 2019 in Philadelphia….The Company currently has out-licensing agreements in several territories and has received approximately $17 million in upfront and milestone payments to date.”

 

Otezla (apremilast) / Celgene
Otezla sales projection: Tracking at $507M (US: $411M, ex-US: $96M) in Q2 2019 (RBC Capital Markets (Canada)) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67384271; Page no: 3; REPORT TITLE: “Biotech: Noteworthy wkly Rx trends/forecast (HIV, HCV, MS, CGRP, TKI, Otezla): RBC biotech coverage w/e 5/17 – Wk 7 of 2Q”; AUTHOR: Abrahams, Brian, et al; DATE: 05/24/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $6B in 2022 (Jefferies) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382641; Page no: 1; REPORT TITLE: “Novartis AG – Our key takeaways from upbeat meet the management event”; AUTHOR: Welford, Peter, et al; DATE: 05/24/2019

 

Otezla (apremilast) / Celgene
Otezla sales projection: $1.9B in 2019 (Zacks) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67403127; Page no: 6; REPORT TITLE: “Celgene Corporation(CELG) Zacks company report”; AUTHOR: Research Department; DATE: 05/28/2019

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Weekly Top News – Psoriasis – June 3, 2019

June 3, 2019

Cosentyx (secukinumab) / Novartis
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #LB0006; Pres time: Jun 15, 2019; 08:18 AM – 08:24 AM; Location: Hall 7B; “Subcutaneous secukinumab provided sustained inhibition of radiographic progression and sustained clinical responses through 2 years of treatment in pts with active PsA.”

 

Taltz (ixekizumab) / Eli Lilly
EFFICACY OF IXEKIZUMAB IN ACTIVE PSORIATIC ARTHRITIS (PSA) PATIENTS WITH AXIAL PAIN STARTING BEFORE AGE 45: A SUBGROUP ANALYSIS OF SPIRIT-P1 AND SPIRIT-P2 PHASE 3 CLINICAL TRIALS (EULAR 2019) – May 27, 2019 – Abstract #AB0744; P3; “Ixekizumab treatment yielded significantly higher improvements than placebo in axial pain, fatigue, stiffness, and physical function at Weeks 16 and 24 in the integrated PsA subpopulation self-reporting axial pain at baseline. These analyses were limited by a lack of baseline axial imaging.”

 

Halimatoz (adalimumab biosimilar) / Novartis
EFFICACY, SAFETY, AND IMMUNOGENICITY RESULTS OF THE SWITCH FROM REFERENCE ADALIMUMAB (REFADL) TO SANDOZ BIOSIMILAR ADALIMUMAB (GP2017, SDZ-ADL) FROM ADMYRA PHASE 3 STUDY IN PATIENTS WITH MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS (RA) (EULAR 2019) – May 27, 2019 – Abstract #FRI0087; Pres time: Jun 14, 2019; P3; “ADMYRA was a Phase 3 study comparing efficacy and safety of SDZ-ADL and refADL in patients with moderate-to-severe RA with inadequate response to disease modifying anti-rheumatic drugs, including methotrexate (NCT02744755). After the switch from reference to biosimilar, the rates of EULAR remission/response and Boolean remission were high and maintained until Week 48. Treatment switch from refADL to SDZ-ADL at Wk 24 did not impact efficacy, safety, or immunogenicity.”

 

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.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 2B STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF TILDRAKIZUMAB, A HIGH-AFFINITY ANTI-INTERLEUKIN-23P19 MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2019)- May 27, 2019 – Abstract #LB0002; Pres time: Jun 12, 2019; 05:35 PM – 05:45 PM; Location: Hall 6; P2b; “Stable concomitant methotrexate or leflunomide use was permitted but not mandated. By week 24, TIL was significantly more efficacious than PBO in treatment of joint and skin manifestations of PsA. Furthermore, there was a clear separation between TIL and PBO as early as 8 weeks for ACR20 (TIL 200 mg Q4W and 100 mg) and 12 weeks for ACR50 (all TIL groups). Shortening the dosing interval from Q12W to Q4W for the 200-mg dose did not result in a measurable increase in skin or joint response scores.”

 

Humira (adalimumab) / Eisai, AbbVie; Taltz (ixekizumab) / Eli Lilly
MULTICENTRE, RANDOMISED, OPEN-LABEL, ASSESSOR-BLINDED, PARALLEL-GROUP HEAD-TO-HEAD COMPARISON OF THE EFFICACY AND SAFETY OF IXEKIZUMAB VERSUS ADALIMUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS NAIVE TO BIOLOGIC DISEASE-MODIFYING ANTI-RHEUMATIC (EULAR 2019)- May 27, 2019 – Abstract #LB0005; Pres time: Jun 15, 2019; 08:12 AM – 08:18 AM; Location: Hall 7B; P4; “In bDMARD naive pts with active PsA and skin disease, IXE showed superior efficacy to ADA based on simultaneous achievement of ACR50 and PASI100 responses at wk 24. Greater improvements with IXE vs ADA were also attained in individual PsA domains and composite T2T outcomes.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
ANVISA approves Skyrizi (risanquizumab) for the treatment of moderate to severe plaque psoriasis [Google translation] (PRNewswire) – May 28, 2019 – “Abbvie…today announced that ANVISA approved SKYRIZI ® (risanquizumabe) for the treatment of psoriasis in moderate to severe plaque in patients adults who are candidates for phototherapy or systemic treatment….The approval was published in the Official Gazette of the Union on May 27, 2019.”

 

Tremfya (guselkumab) / J&J
Janssen announces Health Canada approval of Tremfya One-Press (guselkumab) – A patient-controlled injector for adults with moderate-to-severe plaque psoriasis(Canada Newswire) – May 29, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved TREMFYA ONE-PRESS, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.”

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
INTEGRATED SAFETY ANALYSIS ACROSS PHASE 3 CLINICAL STUDIES INCLUDING THE CONTROLLED AND UNCONTROLLED PERIODS FOR INTRAVENOUS GOLIMUMAB IN RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND ANKYLOSING SPONDYLITIS (EULAR 2019) – May 27, 2019 – Abstract #AB0385; “The proportion of IV GLM and PBO pts with post-baseline ALT elevations ≥5X ULN was 2.1% vs 0% with methotrexate and 0.7% vs 1.4% without methotrexate use at baseline, respectively. IV GLM demonstrated a consistent safety profile across indications in the PBO-controlled (up to WK 24) and uncontrolled study periods. Similar to WK 24 (1), more safety events occurred in RA pts, who represented the largest study population with older pts, longer disease duration, and more concomitant medication use.”

 

Orencia (abatacept) / BMS
SAFETY OF ABATACEPT TREATMENT OVER 2 YEARS IN A PHASE III ACTIVE PSORIATIC ARTHRITIS RANDOMIZED TRIAL (ASTRAEA) (EULAR 2019) – May 27, 2019 – Abstract #AB0763; P3; “Abatacept was well tolerated up to 2 years with no new safety signals during the LTE in this Phase III study in PsA. There was no impact of concomitant MTX use or prior TNFi exposure on the safety profile of abatacept. The occurrence of anti-abatacept antibodies had no impact on abatacept efficacy or safety.”

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Weekly Top News – Psoriasis – May 27, 2019

May 27, 2019

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory approval in China for psoriasis at the end of 2019 (Novartis) – May 25, 2019 – Investor Event: Regulatory approval in China for ankylosing spondylitis at the end of 2020
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Data from P3 EXCEED trial (NCT02745080) for psoriatic arthritis in 2019/2020 (Novartis) – May 25, 2019 – Investor Event: Data from P3 SURPASS trial (NCT03259074) for ankylosing spondylitis in 2022
[Screenshot]

 

benvitimod (GSK2894512) / Roivant
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001) (clinicaltrials.gov) – May 20, 2019 – P3; N=500; Not yet recruiting; Sponsor: Dermavant Sciences GmbH

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Data from P2 ARROW trial (NCT03553823) for plaque psoriasis at the end of 2019 (Novartis) – May 25, 2019 – Investor Event
[Screenshot]

 

ANB019 / AnaptysBio
ANB019: Top-line data from P2 POPLAR trial (NCT03633396) for palmoplantar pustulosis in H1 2020 (Bank of America Merrill Lynch Health Care Conference 2019, AnaptysBio) – May 23, 2019
[Screenshot]

 

ABBV-157 / AbbVie, Inventiva
ABBV-157: Initiation of P1 trial (NCT03922607) for chronic plaque psoriasis in May 2019 (Inventiva) – May 21, 2019 – Company presentation: Completion of P1 trial for chronic plaque psoriasis in September 2020
[Screenshot]

 

PF-06700841 / Pfizer
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 24, 2019 – P2b; N=196; Not yet recruiting; Sponsor: Pfizer

 

Stelara (ustekinumab) / J&J
A Case of Eosinophilic Pneumonia Secondary to Ustekinumab in the Treatment of Crohn’s Disease (ATS 2019) – May 24, 2019 – Abstract #A1476/P475; Pres time: May 19, 2019; 11:15 AM – 01:00 PM; Location: Area D (Hall F, Level 2), KBHCCD; “…His treatment regimen included methotrexate for over one year and he had received his first dose of ustekinumab 6 weeks prior to presentation…Cefepime, metronidazole, azithromycin and vancomycin were initiated…The patient was treated with Methylprednisolone 500 mg IV for 3 days, tapered to 125 mg IV for 3 days, followed by a six week prednisone taper…Ustekinumab has also been associated with hypersensitivity pneumonitis and interstitial lung disease with a granulomatous component. In patients taking ustekinumab with respiratory failure and parenchymal opacities on chest radiograph, eosinophilic pneumonia should be considered.”

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Weekly Top News – Psoriasis – May 20, 2019

May 20, 2019

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
[Screenshot]

 

benvitimod (GSK2894512) / Roivant
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults (clinicaltrials.gov) – May 20, 2019 – P3; N=500; Not yet recruiting; Sponsor: Dermavant Sciences GmbH

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Psoriasis, brodalumab is redeemable in Italy (AboutPharma) – May 17, 2019 – “The first biological drug from LEO Pharma arrives in Italy: a monoclonal antibody against moderate-severe plaque psoriasis. In fact, brodalumab was repaid in Italy…The OK of the Italian Drug Agency, approved in recent weeks, was announced yesterday in Rome by LEO Pharma.”

 

Cosentyx (secukinumab) / Novartis; bimekizumab (UCB4940) / UCB
BE RADIANT: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – May 13, 2019 – P3; N=743; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Active, not recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – May 14, 2019 – P3; N=100; Recruiting; Sponsor: AbbVie; Not yet recruiting –> Recruiting

 

Otezla (apremilast) / Celgene
Otezla pricing: Wholesale acquisition cost of $3398/month (Jefferies) – May 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 67209046; Page no: 67; REPORT TITLE: “Initiating microbiome-based therapeutics: Novel science poised for NT success”; AUTHOR: Song, Roger, et al; DATE: 04/30/2019

 

ABBV-157 / AbbVie, Inventiva
Q1 2019 financial information and corporate business update (GlobeNewswire) – May 15, 2019 – “AbbVie continues the clinical development of ABBV-157, the drug candidate resulting from its collaboration with Inventiva. Following a first Phase I clinical trial, AbbVie recently reported its intention to initiate a new clinical study with ABBV-157, aiming at assessing the compound’s pharmacokinetics, safety and tolerance in healthy volunteers and in patients with chronic plaque psoriasis.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $120M (consensus: $200-300M) peak (Credit Suisse) – May 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 67226255; Page no: 4; REPORT TITLE: “Credit Suisse India Daily: Top stories and ideas”; AUTHOR: Gupta, Ashish, et al; DATE: 05/02/2019

 

Stelara (ustekinumab) / J&J
“Ustekinumab Offers Better Drug Survival to Treat Pediatric Psoriasis https://t.co/0qjn7PNced @NPF” (@NPFjim) – May 17, 2019

 

MP1032 / MetrioPharm
EQS-News: MetrioPharm AG: MetrioPharm AG publishes annual report for 2018 (Business Insider) – May 16, 2019 – “In the past fiscal year, we were able to decisively advance the development of our lead compound MP1032. Phase II clinical trial successfully initiated…for the indication psoriasis started. Patient recruitment has now been completed to our satisfaction.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx TRx trend: +38% till date in Q2 2019 (J.P. Morgan) – May 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67253598; Page no: 1; REPORT TITLE: “European Pharmaceuticals: Weekly chartbook: TRx for week ending 26th April”; AUTHOR: Vosser, Richard, et al; DATE: 05/06/2019

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Weekly Top News – Psoriasis – May 13, 2019

May 13, 2019

Cosentyx (secukinumab) / Novartis
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL (EULAR 2019) – May 10, 2019 – Abstract #LB0006; Pres time: Jun 15, 2019; 08:18 AM – 08:24 AM; Location: Hall 7B; No abstract available.

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES THE SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS REGARDLESS OF SEX, DURATION OF DISEASE, OR BODY MASS INDEX IN TWO RANDOMIZED, PHASE 3 CLINICAL TRIALS (EULAR 2019) – May 10, 2019 – Abstract #FRI0430; Pres time: Jun 14, 2019; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 2B STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF TILDRAKIZUMAB, A HIGH-AFFINITY ANTI–INTERLEUKIN-23P19 MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2019) – May 10, 2019 – Abstract #LB0002; Pres time: Jun 12, 2019; 05:35 PM – 05:45 PM; Location: Hall 6; No abstract available.

 

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.”

 

Humira (adalimumab) / Eisai, AbbVie; bimekizumab (UCB4940) / UCB
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 7, 2019 – P3; N=840; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

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Weekly Top News – Psoriasis – May 6, 2019

May 6, 2019

Psoriasis

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
European Commission approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (AbbVie Press Release) – Apr 30, 2019 – “AbbVie…today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks…This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway….SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Long-term safety of tildrakizumab in patients with moderate-to-severe psoriasis: incidence of major adverse cardiovascular events through 148 weeks from reSURFACE 1 and reSURFACE 2 phase 3 trials (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:10 PM – 03:20 PM; Location: BROWN 3; No abstract available.

 

Otezla (apremilast) / Celgene
A Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy (clinicaltrials.gov) – Apr 29, 2019 – P3b; N=150; Not yet recruiting; Sponsor: Celgene

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 30, 2019 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

 

pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – May 3, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Otezla (apremilast) / Celgene
DISCREET: An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis (clinicaltrials.gov) – May 1, 2019 – P3; N=332; Recruiting; Sponsor: Celgene; Not yet recruiting –> Recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab is Associated With Low and Consistent Infection Rates in Patients With Moderate-to-Severe Psoriasis: Analysis of Short-Term and Long-Term Pooled Clinical Trial Data (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 02:50 PM – 03:00 PM; Location: BROWN 3; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi pricing: Wholesales acquisition cost of $59,000/year for maintenance dose and $88,500/year for therapy of new patients (UBS) – May 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67166772; Page no: 1; REPORT TITLE: “AbbVie Inc.- First read: AbbVie “Skyrizi approval is incrementally positive; Clean …”; AUTHOR: Jacob, Navin, et al; DATE: 04/23/2019

 

mirikizumab (LY3074828) / Eli Lilly
Improvement in Psoriasis Scalp Severity Index (PSSI) during Maintenance Treatment with Mirikizumab (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:50 PM – 04:00 PM; Location: BROWN 3; No abstract available.

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Weekly Top News – Psoriasis – April 29, 2019

April 29, 2019

BMS-986165 / BMS

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) – Apr 23, 2019 – P3; N=80; Recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis

Cosentyx: 5-year data from P3 FUTURE 2 trial (NCT01752634) for psoriatic arthritis at ACR (November 8-13, 2019) (Novartis) – Apr 24, 2019 – Q1 2019 Results: 2-year data from P3 FUTURE 5 trial (NCT02404350) for psoriatic arthritis at EULAR (June 12- 15, 2019)
P3 data
[Screenshot]

 

Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen

Samsung Bioepis wins FDA approval for biosimilar (Yonhap News Agency) – Apr 26, 2019 – “…Samsung Bioepis…has won approval from the U.S. Food and Drug Administration to sell one of its biosimilar in the United States. Etanercept — a biosimilar referencing the immunology drug Enbrel developed by U.S.-based Amgen Inc. — will be used in the treatment of rheumatoid arthritis and psoriatic arthritis, the company said in a press release. However, it is undecided yet when Etanercept will go on sale in the U.S. as the patent for Enbrel is to expire in 2029.”
BLA • Patent

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim

AbbVie expands immunology portfolio in the U.S. with FDA approval of Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis (PRNewswire) – Apr 23, 2019 – “AbbVie…announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy….The approval of SKYRIZI is supported by results from AbbVie’s global Phase 3 psoriasis program, which assessed the safety and efficacy of SKYRIZI in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent.”
BLA

 

Humira (adalimumab) / Eisai, AbbVie

The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis (clinicaltrials.gov) – Apr 25, 2019 – P3; N=330; Not yet recruiting; Sponsor: Sinocelltech Ltd.
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis

Cosentyx: Launch in China for psoriasis in H2 2019 (Novartis) – Apr 24, 2019 – Q1 2019 Results
Launch non-US
[Screenshot]

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin; Stelara (ustekinumab) / J&J

New data show that LEO Pharma’s Kyntheum (brodalumab) sustains PASI 100 scores longer than ustekinumab for people with moderate-to-severe plaque psoriasis (Businesswire) – Apr 25, 2019 – P3, N=1,831; AMAGINE-2 (NCT01708603); P3, N=1,881; AMAGINE-3 (NCT01708629); Sponsor: Amgen; “LEO Pharma…today announced that new data presented this week at the 6th Congress of the Skin Inflammation and Psoriasis International Network (SPIN) in Paris demonstrate that more patients with moderate-to-severe psoriasis who received treatment with brodalumab maintained a PASI (Psoriasis Area Severity Index) 100 score for longer than those who were treated with ustekinumab over 52 weeks.”
Retrospective data

 

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Weekly Top News – Psoriasis – April 22, 2019

April 22, 2019

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Health Canada approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (Canada Newswire) – Apr 18, 2019 – “AbbVie…announced today that Health Canada has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy….SKYRIZI received Health Canada approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.”
Canadian regulatory

 

KD025  / Kadmon
KD025 US launch estimate: 2021 in plaque psoriasis (Jefferies) – Apr 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 66898956; Page no: 4; REPORT TITLE: “Kadmon Holdings Inc – Q4 ’18: Pivotal study readout for KD025 in cgvhd expected at YE ’19”; AUTHOR: Amin, Biren, et al; DATE: 03/08/2019
Launch US

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
NICE publishes final recommendation for Ilumetri (Pharmafield) – Apr 17, 2019 – “NICE has published final recommendation for ILUMETRI (Tildrakizumab), as a cost-effective option for adults with moderate-to-severe plaque psoriasis.”
NICE

 

Tremfya (guselkumab) / J&J
A brighter future for psoriasis patients in Egypt (Egypt Today) – Apr 15, 2019 – “Ministry of health approved the first biological treatment of moderate to severe plaque psoriasis patients….Tremfya is the first biologic treatment approved by the ministry of health under resolution 820, which allows the registration of FDA-approved treatments and European EMEA in a short period of up to three months, which confirms the ministry’s mission to provide advanced biological treatments that help to heal the Egyptian patient as soon as possible.”
Non-US regulatory

 

Enbrel (etanercept) / Takeda, Pfizer, Amgen
A RANDOMIZED, PHASE 3, DOUBLE-BLIND TRIAL EXAMINING METHOTREXATE AND ETANERCEPT AS MONOTHERAPY OR IN COMBINATION FOR TREATING PSORIATIC ARTHRITIS: A COMPARISON OF THE COMPOSITE MEASURES USED TO EVALUATE DISEASE ACTIVITY (EULAR 2019) – Apr 16, 2019 – Abstract #OP0111; Pres time: Jun 13, 2019; 10:50 AM – 11:00 AM; Location: Hall 8; No abstract available.
Clinical • Monotherapy • P3 data

 

Cosentyx (secukinumab) / Novartis
SECUKINUMAB IMPROVES AXIAL MANIFESTATIONS IN PATIENTS WITH PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO NSAIDS: PRIMARY ANALYSIS OF THE MAXIMISE TRIAL (EULAR 2019) – Apr 16, 2019 – Abstract #OP0235; Pres time: Jun 14, 2019; 11:00 AM – 11:10 AM; Location: Hall 7A; No abstract available.
Clinical

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS IN PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO 1 OR 2 TUMOR NECROSIS FACTOR INHIBITORS (EULAR 2019) – Apr 16, 2019 – Abstract #OP0110; Pres time: Jun 13, 2019; 10:40 AM – 10:50 AM; Location: Hall 8; No abstract available.
Clinical

 

Cosentyx (secukinumab) / Novartis
MACHINE LEARNING TOOLS IDENTIFY PATIENT CLUSTERS AND SWOLLEN AND TENDER JOINT CORRELATION PATTERNS IN A LARGE DATABASE FROM THE SECUKINUMAB PSORIATIC ARTHRITIS CLINICAL DEVELOPMENT PROGRAM (EULAR 2019) – Apr 16, 2019 – Abstract #OP0114; Pres time: Jun 13, 2019; 11:20 AM – 11:30 AM; Location: Hall 8; No abstract available.
Clinical

 

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Weekly Top News – Psoriasis – 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

 

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Data from P3 BE SURE trial (NCT03412747) for psoriasis in H1 2019 (Infinata) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 66478978; Page no: 2; REPORT TITLE: “UCB S.A. – Company report”; AUTHOR: Infinata, et al; DATE: 03/05/2019
P3 data

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Apr 1, 2019 – P3; N=136; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab regulatory estimate: PDUFA date for psoriasis on April 26, 2019 (William Blair) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67011697; Page no: 5; REPORT TITLE: “William Blair Biopharma Catalyst watch second quarter 2019”; AUTHOR: Xu, Yu Katherine, et al; DATE: 03/29/2019
PDUFA date

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 1, 2019 – P3; N=390; Not yet recruiting; Sponsor: UCB Biopharma S.P.R.L.
Clinical • New P3 trial

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (clinicaltrials.gov) – Apr 1, 2019 – P3; N=146; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis
Novartis first-in-class Cosentyx approved in China for psoriasis patients (Novartis Press Release) – Apr 2, 2019 – “Novartis…announced today that the China Health Authority NMPA approved Cosentyx® (secukinumab), the first-in-class interleukin-17A (IL-17A) inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy…Positive China data presented recently makes us hopeful for the clinical use of secukinumab in China.”
Non-US regulatory

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