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Category: Psoriasis

Weekly Top News – Psoriasis – November 11, 2019

November 11, 2019

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen (clinicaltrials.gov) – Nov 6, 2019 – P4; N=300; Recruiting; Sponsor: Bausch Health Americas, Inc.

 

Tremfya (guselkumab) / J&J
Tremfya (guselkumab), a first-in-class il-23 p19 subunit inhibitor, meets primary endpoints of superior ACR20 responses versus placebo at week 24 in phase 3 psoriatic arthritis studies (PRNewswire) – Nov 11, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 24-week Phase 3 data showing a significantly greater proportion of patients with active psoriatic arthritis (PsA) treated with TREMFYA® (guselkumab)…These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase 3 studies…These data were presented…at the American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) 2019 Annual Meeting taking place November 8-13 in Atlanta.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ) (clinicaltrials.gov) – Nov 5, 2019 – P3; N=2200; Enrolling by invitation; Sponsor: AbbVie; Active, not recruiting –> Enrolling by invitation; Trial completion date: Jan 2022 –> Nov 2023; Trial primary completion date: Jan 2022 –> Nov 2023

 

Humira (adalimumab) / Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie to showcase depth of immunology portfolio and pipeline at the 2019 ACR/ARP Annual Meeting (PRNewswire) – Nov 4, 2019 – “AbbVie…today announced it will present data from multiple studies of RINVOQ™ (upadacitinib), HUMIRA® (adalimumab) and SKYRIZI™ (risankizumab) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, November 8-13, in Atlanta. A total of 38 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA).”

 

Olumiant (baricitinib) / Incyte, Eli Lilly; Taltz (ixekizumab) / Eli Lilly
Lilly reinforces its commitment to rheumatology through data showcased at the ACR/ARP Annual Meeting (Eli Lilly Press Release) – Nov 8, 2019 – “Eli Lilly and Company…announced today that it will present new data from Taltz® (ixekizumab) and Olumiant® (baricitinib) at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) annual meeting taking place Nov. 8-13, 2019 in Atlanta. The presentations will highlight the latest therapeutic data…including…ankylosing spondylitis (AS); psoriatic arthritis (PsA) and rheumatoid arthritis (RA), along with the latest investigative data for non-radiographic axial spondyloarthritis (nr-axSpA) and systemic lupus erythematosus (SLE).”

 

Cimzia (certolizumab pegol) / Astellas, Dermira, UCB; bimekizumab (UCB4940) / UCB
UCB presents new data from rheumatology portfolio addressing unmet needs in axial spondyloarthritis, psoriatic arthritis and lupus at 2019 ACR/ARP (PRNewswire) – Nov 8, 2019 – “UCB…today announced important new rheumatology data being presented on CIMZIA® (certolizumab pegol) and investigational molecules bimekizumab and dapirolizumab pegol at the 2019 American College of Rheumatology and the Association of Rheumatology Professionals (ACR/ARP) Annual Meeting in Atlanta, on November 8-13.”

 

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) – Nov 8, 2019 – P3; N=108; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $275M in 2020 (Wolfe Research) – Nov 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68243153; Page no: 2; REPORT TITLE: “Abbvie Inc Global Pharmaceuticals – ABBV: 3Q19 – They just said what?! Highlights from conference call that just ended”; AUTHOR: Anderson, Tim, et al; DATE: 11/01/2019

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Weekly Top News – Psoriasis – November 4, 2019

November 4, 2019

Cosentyx (secukinumab) / Novartis; Humira (adalimumab) / Eisai, AbbVie
Novartis Cosentyx shows encouraging results versus Humira from first of its kind head-to-head trial in psoriatic arthritis (Novartis Press Release) – Nov 1, 2019 – P3, N=850; EXCEED (NCT02745080); Sponsor: Novartis Pharmaceuticals; “Novartis…announced results from the EXCEED head-to-head trial comparing Cosentyx® (secukinumab) to Humira…in patients with active psoriatic arthritis (PsA)[1]. While Cosentyx narrowly missed statistical significance for superiority in ACR 20, the primary endpoint of the EXCEED trial, it showed numerically higher results versus Humira…Statistically significant advantages of Cosentyx versus Humira®* in PsA-specific endpoints were observed in a pre-specified sensitivity analysis. The trial demonstrated a consistent and favorable safety profile for Cosentyx in line with previous clinical trials…No new safety signals were detected.”

 

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) in pediatric patients with moderate to severe plaque psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (GlobeNewswire) – Oct 28, 2019 – P3, N=201; “Eli Lilly and Company announced that TALTZ met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis…Results of the study were presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.”

 

Humira (adalimumab) / Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie to showcase depth of immunology portfolio and pipeline at the 2019 ACR/ARP Annual Meeting (PRNewswire) – Nov 4, 2019 – “AbbVie…today announced it will present data from multiple studies of RINVOQ™ (upadacitinib), HUMIRA® (adalimumab) and SKYRIZI™ (risankizumab) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, November 8-13, in Atlanta. A total of 38 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA).”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie’s new psoriasis drug likely to win nod this year (Korea Biomedical Review) – Oct 30, 2019 – “AbbVie’s new psoriasis treatment Risankizumab is likely to obtain local license within this year, heating the competition in the psoriasis treatment market….The Ministry of Food and Drug Safety is reviewing the drug for approval, sources said.”

 

Stelara (ustekinumab) / J&J; Remicade (infliximab) / Mitsubishi Tanabe, J&J; Tremfya (guselkumab) / J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Janssen presenting data from its expanding rheumatology portfolio at the 2019 annual meeting of The American College of Rheumatology (PRNewswire) – Oct 31, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will be presenting results from 30 abstracts across the company’s expanding rheumatology portfolio and pipeline products during the 2019 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting taking place in Atlanta, Georgia from November 8-13.”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: July 2024 in EU (Kepler Cheuvreux) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68195721; Page no: 1; REPORT TITLE: “Formycon AG Espresso Note | Formycon | Buy | start of phase I for FYB202”; AUTHOR: Choplain, Damien, et al; DATE: 10/28/2019

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Ahead of World Psoriasis Day, Bausch Health, Canada announces that Siliq (brodalumab) is now covered on most drug benefit formularies in Canada (Yahoo Finance) – Oct 29, 2019 – “In advance of World Psoriasis Day on October 29, 2019 , Bausch Health Companies…is pleased to announce that SILIQ (brodalumab)3 is now listed on the majority of provincial drug benefit formularies in Canada , ensuring improved treatment access for the nearly 800,000 Canadians currently living with plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $142M in Q4 2019 and $268M in FY2019 (UBS) – Oct 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 68132444; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 10/18/2019

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Weekly Top News – Psoriasis – October 28, 2019

October 28, 2019

Tremfya (guselkumab) / J&J
Janssen brings to Spain Tremfya One-Press for the treatment of psoriasis [Google Translation] (Redacción Médica) – Oct 22, 2019 – “Janssen Pharmaceutical Companies of Johnson & Johnson has announced the commercialization in Spain of the Tremfya One-Press pre-filled pen, a new self-injectable administration device for guselkumab, indicated for the treatment of moderate to severe plaque psoriasis in adult candidates for systemic treatment….Designed to facilitate the time of the self-injection of patients with psoriasis.”

 

Tremfya (guselkumab) / J&J
Janssen seeks to expand use of Tremfya (guselkumab) in the treatment of adults with active psoriatic arthritis (Businesswire) – Oct 23, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II Variation Application to the European Medicines Agency (EMA) seeking first-in-class approval of TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).”

 

Cosentyx (secukinumab) / Novartis
Novartis delivered another strong quarter with double digit sales growth and core1 margin expansion; 2019 sales and profit guidance raised; Beovu launched in US (GlobeNewswire) – Oct 22, 2019 – “Continuing operations net sales up 13% (cc1, +10% USD) driven by: Cosentyx sales of USD 937 million (+27% cc), with strong demand across indications and regions…Cosentyx met primary endpoints in nr-axSpA…FDA submission planned for Q4.”

 

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) in pediatric patients with moderate to severe plaque psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (GlobeNewswire) – Oct 28, 2019 – P3, N=201; “Eli Lilly and Company announced that TALTZ met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis…Results of the study were presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.”

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 VIVID-1 trial (NCT03926130) for Crohn’s disease in Feb 2022 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 VIVID-1 trial for Crohn’s disease in Jul 2023; Completion of P3 OASIS-1 trial (NCT03482011) in moderate-to-severe plaque psoriasis in Feb 2020 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 OASIS-2 trial (NCT03535194) in moderate-to-severe plaque psoriasis in Mar 2020 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 OASIS-2 trial in moderate-to-severe plaque psoriasis in Dec 2020; Primary completion and completion of P3 OASIS-3 trial (NCT03556202) in moderate-to-severe plaque psoriasis in May 2024 
[Screenshot]

 

GSK2831781 / GSK
GSK2831781 clinical trial estimate: Primary completion of P1 trial for healthy volunteers in Japan in January 2020 (GlobalData) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67598395; Page no: 176; REPORT TITLE: “Immutep Ltd (IMM) – Financial analysis review”; AUTHOR: Globaldata; DATE: 09/24/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Completion of P3b trial (NCT03504852) for psoriasis in H2 2020 (Novartis) – Oct 22, 2019 – Q3 2019 Results: Completion of P3 MATURE trial (NCT03589885) for psoriasis in H2 2020 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Completion of P3 trial (NCT02471144) for psoriasis in 2023 (Novartis) – Oct 22, 2019 – Q3 2019 Results: Completion of P3 trial (NCT03668613) for psoriasis in 2023 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Completion of P3 trial (NCT03031782) for psoriatic arthritis in 2021 (Novartis) – Oct 22, 2019 – Q3 2019 Results 
[Screenshot]

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Weekly Top News – Psoriasis – October 21, 2019

October 21, 2019

Tremfya (guselkumab) / J&J
Janssen presents new four-year Tremfya (guselkumab) data demonstrating maintained rates of skin clearance in adult patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 17, 2019 – P3, N=837; VOYAGE 1 (NCT02207231); Sponsor: Janssen; “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the Phase 3 VOYAGE 1 clinical trial. These data showed that 82 percent of patients receiving TREMFYA® (guselkumab) in the combined group of patients initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16 achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 204 (4 years)….The data are being presented at the 39th Fall Clinical Dermatology Conference in Las Vegas, Nevada.”

 

Tremfya (guselkumab) / J&J
Guselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study (ACR-ARHP 2019) – Oct 19, 2019 – Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; “In pts with active PsA, GUS Q4W and Q8W significantly improved joint and skin symptoms, physical function, and quality of life, and resolved enthesitis/dactylitis. GUS Q4W significantly reduced radiographic damage progression vs. PBO.”

 

Tremfya (guselkumab) / J&J
Guselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study (ACR-ARHP 2019) – Oct 19, 2019 – Abstract #L13; Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; “In pts with active PsA, GUS Q4W and Q8W significantly improved joint and skin symptoms, physical function, and quality of life, and resolved enthesitis/dactylitis. GUS Q4W significantly reduced radiographic damage progression vs. PBO.”

 

Stelara (ustekinumab) / J&J; bimekizumab (UCB4940) / UCB
Bimekizumab phase 3 psoriasis study meets all endpoints, achieving significantly greater efficacy versus placebo and ustekinumab (PRNewswire) – Oct 17, 2019 – P3, N=570; BE VIVID (NCT03370133); Sponsor: UCB Biopharma; “UCB…today announced positive results from BE VIVID, the first of three Phase 3 studies evaluating the efficacy and safety of bimekizumab…in the treatment of adults with moderate-to-severe chronic plaque psoriasis….We look forward to sharing further findings from the bimekizumab clinical development program in the coming months.”

 

Xeljanz (tofacitinib) / Pfizer
Tofacitinib as Monotherapy Following Methotrexate Withdrawal in Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL Balance (ACR-ARHP 2019) – Oct 19, 2019 – Abstract #L14; Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; P3; “In general, no clinically meaningful differences in efficacy and safety were observed in pts with PsA who received OL tofacitinib 5 mg BID as monotherapy after MTX withdrawal vs with continued MTX. No new safety risks were identified. Limitations include that the sub‑study was designed as an estimation study and not powered for hypothesis testing, and only pts on long-term treatment who had responded well to, and tolerated, tofacitinib and MTX were included.”

 

Xeljanz (tofacitinib) / Pfizer
Tofacitinib as Monotherapy Following Methotrexate Withdrawal in Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL Balance (ACR-ARHP 2019) – Oct 19, 2019 – Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; P3; “In general, no clinically meaningful differences in efficacy and safety were observed in pts with PsA who received OL tofacitinib 5 mg BID as monotherapy after MTX withdrawal vs with continued MTX. No new safety risks were identified. Limitations include that the sub‑study was designed as an estimation study and not powered for hypothesis testing, and only pts on long-term treatment who had responded well to, and tolerated, tofacitinib and MTX were included.”

 

GSK2831781 / GSK
GSK2831781 clinical trial estimate: Primary completion of P1 trial for healthy volunteers in Japan in January 2020 (GlobalData) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67598395; Page no: 176; REPORT TITLE: “Immutep Ltd (IMM) – Financial analysis review”; AUTHOR: Globaldata; DATE: 09/24/2019

 

MP1032 / MetrioPharm
MetrioPharm AG phase II data in psoriasis show dose-response, disease modifying activity and outstanding safety profile (MetrioPharm Press Release) – Oct 16, 2019 – P2, N=153; NCT03706209; Sponsor: MetrioPharm AG; “MetrioPharm AG…reports positive results from its recently completed Phase II dose finding study of MP1032 in psoriasis patients….The overall response rate (defined as PASI 50 and 75) more than doubled over placebo with even a 4-fold increase in PASI 75 responders….High dose MP1032 showed a statistically significant reduction in all-cause AEs over placebo thereby confirming the expected benign safety profile.”

 

Otezla (apremilast) / Amgen
Otezla ex-US sales projection: $300-400M in 2019 (Jefferies) – Oct 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 68079059; Page no: 30; REPORT TITLE: “Q3 EPS and thoughts into year-end”; AUTHOR: Yee, Michael, et al; DATE: 10/10/2019

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin; Duobrii (halobetasol/tazarotene) / Bausch Health; Jemdel (halobetasol propionate topical) / Bausch Health
Bausch Health’s Ortho Dermatologics business to present data at the Fall Clinical Dermatology Conference (PRNewswire) – Oct 15, 2019 – “Bausch Health Companies…Ortho Dermatologics…today announced the presentation of 18 posters during the Fall Clinical Dermatology Conference in Las Vegas (Oct. 17-20, 2019). The presentations will feature analyse…BRYHALI® (halobetasol propionate 0.01%) Lotion, DUOBRII® (halobetasol propionate 0.01% and tazarotene 0.045%) Lotion and SILIQ (brodalumab) injection, as well as a new data on the investigational drug IDP-123 (tazarotene 0.045%) Lotion.”

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Weekly Top News – Psoriasis – October 14, 2019

October 14, 2019

Stelara (ustekinumab) / J&J
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of pediatric patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 7, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO)….The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma presents long-term study results that show significant skin clearance with Ilumya (tildrakizumab-asmn) maintained over four years in people with moderate-to-severe plaque psoriasis (PRNewswire) – Oct 9, 2019 – P3, N=772; reSURFACE 1 (NCT01722331); Sponsor: Sun Pharma; P3, N=1,090; reSURFACE 2 (NCT01729754); Sponsor: Sun Pharma; “Sun Pharmaceutical Industries…today announced that one of its wholly owned subsidiaries presented long-term follow-up data from ILUMYA

® (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.”

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) in pediatric patients with moderate to severe plaque psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (Eli Lilly Press Release) – Oct 12, 2019 – P3, N=201; Ixora-peds (NCT03073200); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area…Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain….Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NHS Scotland accepts AbbVie’s Skyrizi (risankizumab) (Pharmafield) – Oct 8, 2019 – “NHS Scotland accepts AbbVie’s SKYRIZI (risankizumab) in a positive Detailed Advice Document published by the Scottish Medicine Consortium….It confirms that SKYRIZI (risankizumab) is recommended for the treatment of moderate to severe psoriasis in adult patients”

 

Cosentyx (secukinumab) / Novartis
Novartis real-world evidence confirms high efficacy, long-term response and favorable safety profile of Cosentyx in clinical practice (Novartis Press Release) – Oct 9, 2019 – “These extensive results confirm what has been previously observed in Phase 3 clinical trials, and support our continued use of Cosentyx in psoriatic disease…Real-world evidence and observational studies help to bridge the gap in knowledge that exists between clinical trials and clinical practice….These data are being presented at the 28th Congress of the European Academy of Dermatology and Venereology (EADV), 9-13 October 2019, Madrid, Spain.”

 

bimekizumab (UCB4940) / UCB; Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
UCB showcases wealth of new psoriasis research at EADV 2019 (UCB Press Release) – Oct 9, 2019 – “UCB…today announced new data on…CIMZIA® (certolizumab pegol), in psoriasis and psoriatic arthritis (PsA) will be presented at the 28th European Academy of Dermatology and Venereology congress (EADV) in Madrid, October 9-13, 2019….New 60-week data on novel investigational molecule bimekizumab, from the BE ABLE Phase 2 clinical development program, will be shared in an oral presentation.”

 

Stelara (ustekinumab) / J&J; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LEO Pharma to highlight data at 28th Congress of the European Academy of Dermatology (EADV) (LEO Pharma Press Release) – Oct 9, 2019 – “LEO Pharma…today announced that data from company-sponsored, health economic outcome and investigator-initiated studies will be presented at the 28th annual Congress of the European Academy of Dermatology (EADV), Oct. 9-13, in Madrid, Spain.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Humira (adalimumab) / Eisai, AbbVie
AbbVie announces new data from its dermatology portfolio and pipeline at the 28th European Academy of Dermatology and Venereology (EADV) congress (PRNewswire) – Oct 9, 2019 – “AbbVie…today announced that it will present new results evaluating the safety and efficacy of SKYRIZI™ (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as…upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid….In addition, Phase 2b results evaluating time to treatment response with upadacitinib…under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation.”

 

Taltz (ixekizumab) / Eli Lilly; mirikizumab (LY3074828) / Eli Lilly
Lilly to unveil new data for the treatments of complex dermatological conditions at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (PRNewswire) – Oct 8, 2019 – “Eli Lilly and Company…announced today that it will present new data for Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab at the 28th annual European Academy of Dermatology and Venereology (EADV) Congress taking place Oct. 9-13 in Madrid, Spain…Lilly will present findings from a Phase 3 trial of Taltz for pediatric patients with moderate to severe psoriasis….Posters to be shared around Lilly’s investigational compound, mirikizumab, include research from a study measuring patient outcomes and health-related elements of quality of life for individuals with moderate to severe psoriasis.”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

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Weekly Top News – Psoriasis – October 7, 2019

October 7, 2019

Stelara (ustekinumab) / J&J
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of pediatric patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 7, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO)….The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study…”

Tremfya (guselkumab) / J&J; Taltz (ixekizumab) / Eli Lilly
New head-to-head data show Taltz (ixekizumab) superiority versus Tremfya (guselkumab) in people with moderate to severe plaque psoriasis (PRNewswire) – Oct 3, 2019 – P4, N=1,027; IXORA-R (NCT03573323); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…today presented detailed data at the 5th Annual Maui Derm NP+PA Fall meeting from the Phase 4 IXORA-R study, the first head-to-head (H2H) study…using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint. Taltz met the primary endpoint of superiority vs. TREMFYA in the proportion of patients with moderate to severe plaque psoriasis achieving complete skin clearance…as well as key secondary endpoints. The study is ongoing through Week 24….Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020.”

 

ANB019 / AnaptysBio
AnaptysBio reports positive topline data from interim analysis of GALLOP phase 2 clinical trial of ANB019 monotherapy in moderate to severe generalized pustular psoriasis (AnaptysBio Press Release) – Sep 30, 2019 – P2, N=10; GALLOP (NCT03619902); Sponsor: AnaptysBio, Inc; “AnaptysBio…today announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 in moderate-to-severe generalized pustular psoriasis (GPP) patients, also known as the GALLOP trial. Enrollment is ongoing and AnaptysBio anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020…ANB019 was generally well-tolerated and no serious or severe adverse events were reported in this interim analysis.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9B in 2019 and $2.2B in 2020 (Cowen & Co) – Sep 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2914; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales estimate: $81M (consensus: $65M) in Q3 2019; Skyrizi US sales projection: $243M (consensus: $205M) in FY2019 (UBS) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016563; Page no: 1; REPORT TITLE: “US Pharmaceuticals “UBS healthcare expert symposium: Dermatology panel key …””; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi revenue projection: Guidance of $150M in H2 2019 (Zacks) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67978057; Page no: 5; REPORT TITLE: “AbbVie Inc.(ABBV) Zacks company report”; AUTHOR: Research Department; DATE: 09/18/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales estimate: $86M (consensus: $65M) in Q3 2019; Skyrizi US sales projection: $263M (consensus: $205M) in FY2019 (UBS) – Oct 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 68021393; Page no: 1; REPORT TITLE: “US Pharmaceuticals “New product launch tracker””; AUTHOR: Jacob, Navin, et al; DATE: 09/27/2019

 

BMS-986165 / BMS
BMS-986165 sales projection: Consensus of $3.5B peak (Exane BNP Paribas) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67972680; Page no: 38; REPORT TITLE: “Pharmaceuticals: Champions League 2019: Powered by pulse “; AUTHOR: Hector, Luisa, et al; DATE: 09/17/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $120M peak (Credit Suisse) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 68021370; Page no: 4; REPORT TITLE: “India Pharma Sector – Quick take – Ilumya volume trend not encouraging; Aurobindo gained 47% share in Makena; Uloric exclusivity sees lower competition”; AUTHOR: Aggarwal, Anubhav, et al; DATE: 09/27/2019

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Weekly Top News – Psoriasis – September 30, 2019

September 30, 2019

Taltz (ixekizumab) / Eli Lilly
Efficacy and Safety of Ixekizumab in a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Pediatric Patients with Moderate-to-Severe Plaque Psoriasis (EADV 2019) – Sep 24, 2019 – Abstract #D3T01.1B; Pres time: Oct 12, 2019; 08:45 AM – 09:00 AM; Location: Hall 10 Dalí; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $250M in 2019, $850M in 2020 and $3B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 491; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Taltz (ixekizumab) / Eli Lilly
Taltz sales projection: $1.38B in 2019, $1.93B in 2020 and $3.1B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 484; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019
Sales projection

Otezla (apremilast) / Amgen
Otezla sales projection: $3B in 2024 (Cowen & Co) – Sep 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2914; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Stelara (ustekinumab) / J&J
Stelara WW sales projection: $9B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 479; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $3.27B in 2019, $3.59B in 2020 and $5.1B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 487; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019
Sales projection

Stelara (ustekinumab) / J&J
Stelara WW sales projection: $6.2B in 2019, $7B in 2020 and $10B in 2024 (Cowen & Co) – Sep 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2917; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Tremfya (guselkumab) / J&J
Tremfya WW sales projection: >$2.5B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 481; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Now comes a new effective medicine for psoriasis [Google Translation] – Sep 24, 2019 – “Decision forums have given thumbs to Skyrizi – AbbVie’s innovative drug for plaque psoriasis. – Skyrizi is cost-effective and has a well-documented effect. We are therefore pleased to be able to offer patients this drug, says the head of the Decision Forum Stig A. Slørdahl….We look forward to seeing more of the two-year data from the IMMhance study at the World Congress of Dermatology in June 2020…”

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Weekly Top News – Psoriasis – September 23, 2019

September 23, 2019

Tremfya (guselkumab) / J&J
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis (PRNewswire) – Sep 16, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)….Janssen also expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.”

 

Taltz (ixekizumab) / Eli Lilly
Taltz pricing: Wholesale acquisition cost of $5,162/Injection (J.P. Morgan) – Sep 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67963077; Page no: 20; REPORT TITLE: “European Pharmaceuticals: Weekly Chartbook: trx for week ending September 6th”; AUTHOR: Vosser, Richard, et al; DATE: 09/15/2019

 

Tremfya (guselkumab) / J&J
Tremfya pricing: Wholesale acquisition cost of $10,859/Injection (J.P. Morgan) – Sep 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67963077; Page no: 20; REPORT TITLE: “European Pharmaceuticals: Weekly Chartbook: trx for week ending September 6th”; AUTHOR: Vosser, Richard, et al; DATE: 09/15/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx pricing: Wholesale acquisition cost of $5,179/Injection (J.P. Morgan) – Sep 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67963077; Page no: 20; REPORT TITLE: “European Pharmaceuticals: Weekly Chartbook: trx for week ending September 6th”; AUTHOR: Vosser, Richard, et al; DATE: 09/15/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $250M in 2019, $850M in 2020 and $3B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 491; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Tremfya (guselkumab) / J&J
Tremfya WW sales projection: >$2.5B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 481; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Taltz (ixekizumab) / Eli Lilly
Taltz sales projection: $1.38B in 2019, $1.93B in 2020 and $3.1B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 484; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $3.27B in 2019, $3.59B in 2020 and $5.1B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 487; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Stelara (ustekinumab) / J&J
Stelara WW sales projection: $9B in 2024 (Cowen & Co) – Sep 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 479; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

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Weekly Top News – Psoriasis – September 16, 2019

September 16, 2019

ANB019 / AnaptysBio
ANB019 regulatory estimate: Approval for palmo-plantar pustular psoriasis in US/EU in 2022 (Jefferies) – Sep 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 67790601; Page no: 2; REPORT TITLE: “AnaptysBio Inc – Q2′ 19: Key readouts approaching to the end of the year”; AUTHOR: Amin, Biren, et al; DATE: 08/08/2019

 

ANB019 / AnaptysBio
ANB019 regulatory estimate: Approval for generalized pustular psoriasis in US in 2021 and EU in 2022 (Jefferies) – Sep 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 67790601; Page no: 2; REPORT TITLE: “AnaptysBio Inc – Q2′ 19: Key readouts approaching to the end of the year”; AUTHOR: Amin, Biren, et al; DATE: 08/08/2019

Tremfya (guselkumab) / J&J
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis (PRNewswire) – Sep 16, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)….Janssen also expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.”

 

ANB019 / AnaptysBio
ANB019 clinical trial estimate: Data from P2 GALLOP trial (NCT03619902) for generalized pustular psoriasis in Q4 2019 (Wedbush) – Sep 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 67796743; Page no: 2; REPORT TITLE: “AnaptysBio Inc – 2Q19 financials; Topline ANB019 data imminent, Ph 2b atopic derm data in Q4”; AUTHOR: Nierengarten, David, et al; DATE: 08/09/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.1B in 2020 (CFRA) – Sep 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67896905; Page no: 5; REPORT TITLE: “Amgen Inc.”; AUTHOR: Huang, Kevin, et al; DATE: 08/31/2019

 

Stelara (ustekinumab) / J&J
Serum Institute unveils ₹4,000-cr plant in Pune (The Hindu Business Line) – Sep 9, 2019 – “Union Health Minister…on Monday inaugurated Serum Institute of India’s (SII) new plant with an investment of ₹4,000 crore at Manjri in Pune. The new unit, which will commence operations from November…The unit is built in compliance with the US and European vaccine manufacturing regulations….It will maximise the production of…monoclonal antibodies like…Ustekinumab (Stelara®).”

 

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

 

Cosentyx (secukinumab) / Novartis; Taltz (ixekizumab) / Eli Lilly; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
AllianceRx Walgreens Prime study demonstrates increased adherence and improvement in symptoms for psoriasis patients switching to interleukin-17 inhibitors (PRNewswire) – Sep 11, 2019 – “AllianceRx Walgreens Prime announced results from a new study analyzing data from patients prescribed interleukin-17 (IL-17) inhibitors for psoriasis. Patients reported improvements in psoriatic symptoms and demonstrated increased medication adherence after switching to one of the three IL-17 medications included in the study….Studies have shown that inhibiting IL-17 can help clear psoriasis. Newer biologic medications, such as secukinumab, ixekizumab or brodalumab, focus on inhibiting IL-17.”

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Weekly Top News – Psoriasis – September 9, 2019

September 9, 2019

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi for the treatment of moderate to severe plaque psoriasis in adults is included in the high-cost protection and is available in Sweden [Google Translation] (Mynewsdesk) – Sep 6, 2019 – “Skyrizi (risankizumab) is part of the drug subsidy in Sweden from June 14, 2019 and is now available at Swedish pharmacies….According to a decision from the Dental Care and Medicines Benefit Agency (TLV), Skyrizi (risankizumab) is included in the Swedish drug benefit. Skyrizi has already been approved in Europe for the treatment of moderate to severe plaque psoriasis in adults who need systemic treatment.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Almirall launches ‘Ilumetri’ in Spain for moderate to severe plaque psoriasis in adults [Google Translation] (Infosalus.com) – Sep 2, 2019 – “The pharmaceutical company Almirall has started the commercialization in Spain of ‘Ilumetri’ (tildrakizumab) for the treatment of moderate to severe plaque psoriasis in adults, after receiving the marketing authorization from the European Commission in September 2018 and the decision of the Ministry of Health to include it in the pharmaceutical benefit of the National Health System (SNS) last July.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx regulatory estimate: Approval in axial spondyloarthritis in H2 2020 (Jefferies) – Sep 7, 2019 – A subscription to Thomson ONE is required to gain full access to report 67891655; Page no: 4; REPORT TITLE: “Novartis AG: Wave of new launches underappreciated driving confidence in ongoing upgrades”; AUTHOR: Welford, Peter, et al; DATE: 08/30/2019

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