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Category: Psoriasis

Weekly Top News – Psoriasis – July 22, 2019

July 22, 2019

Cosentyx (secukinumab) / Novartis
Secukinumab Treatment Led to Normalization of Quality of Life and Disease Symptoms in Psoriasis Patients with or without Prior Systemic Psoriasis Therapy: PROSE Study Results (EADV 2019) – Jul 16, 2019 – Abstract #P1632; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

BMS-986165 / BMS
An oral, selective tyrosine kinase 2 inhibitor, BMS-986165, improves quality of life in psoriasis: results from a Phase 2 study (EADV 2019) – Jul 16, 2019 – Abstract #P1621; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab clinical trial estimate: First data from P3 trials OASIS-1 (NCT03482011) and OASIS-2 (NCT03535194) for psoriasis 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

 

Otezla (apremilast) / Celgene
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Plaque Psoriasis of the Scalp: 32-Week Results From the Phase 3, STYLE Study (EADV 2019) – Jul 16, 2019 – Abstract #P1705; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Tildrakizumab Efficacy by Metabolic Syndrome Status in Psoriasis: Post Hoc Analysis of 3-Year Data from the Phase 3 reSURFACE 1 Study (EADV 2019) – Jul 16, 2019 – Abstract #P1653; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

Cosentyx (secukinumab) / Novartis
Cosentyx clinical trial estimate: Primary completion of P3 EXCEED trial (NCT02745080) for psoriatic arthritis in March 2020 and data in late 2019/2020 (Cowen & Co) – Jul 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 524, 587; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Otezla (apremilast) / Celgene
FDA tentatively OKs Amneal’s generic Otezla (SeekingAlpha) – Jul 19, 2019 – “The FDA tentatively approves Amneal Pharmaceuticals’ (AMRX -3.5%) marketing application for a generic version of Celgene’s (CELG -0.5%) psoriasis med Otezla (apremilast).”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission for nrAxSpA in 2019 (Novartis) – Jul 18, 2019 – Q2 2019 Results: Regulatory submission for psoriatic arthritis in 2020  
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Weekly Top News – Psoriasis – July 15, 2019

July 15, 2019

Humira (adalimumab) / Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Comparing patient populations of the risankizumabphase III clinical trial programme to the U.K.general population: results from a British Association of Dermatologists Biologics and Immunomodulators Register analysis (BAD 2019) – Jul 11, 2019 – Abstract #P069; “The BADBIR cohort included 5657 patients aged ≥ 18 years, enrolled during 2007 to September 2017, receiving adalimumab for the first time, and from the U.K. and Republic of Ireland. AbbVie participated in the interpretation of data and review and approval of the publication. No authors were paid for writing this publication.”

 

mirikizumab (LY3074828) / Eli Lilly
Efficacy and safety of mirikizumab ( LY 3074828) in the treatment of moderate-to-severe plaque psoriasis: results from a randomized phase II study (BAD 2019) – Jul 11, 2019 – Abstract #88; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NICE recommends funding for psoriasis and type 1 diabetes drugs (pharmaphorum) – Jul 12, 2019 – “Patients in England and Wales should soon be able to access AbbVie’s psoriasis drug Skyrizi after NICE recommended regular NHS funding….NICE reviewed Skyrizi (risankizumab) and made its recommendation meaning that NHS commissioners are committed to funding within 30 days of final guidance due at the end of August.”

 

Stelara (ustekinumab) / J&J
Retinal toxoplasmosis in psoriasis treated with ustekinumab: a case study (BAD 2019) – Jul 11, 2019 – Abstract #BI29; Pres time: Jul 2, 2019; 08:45 AM – 12:15 PM; Location: Hall 1B; “This has not yet been reported in the literature, and leads to the devastating outcome of permanent loss of vision, despite complete treatment with pyrimethamine, azithromycin, folinic acid and topical therapies. In conclusion, changing our practice depends on ongoing close surveillance of the side-effect profile of this drug to establish the risk better. Without awareness that presentations such as toxoplasma retinitis may be related to therapies such as ustekinumab, there may be under-reporting of these to the Medicines and Healthcare products Regulatory Agency, which will limit our ability to provide any evidence-based guidance.”

 

Stelara (ustekinumab) / J&J; Humira (adalimumab) / Eisai, AbbVie
Phenotypic switch from psoriasis to eczema onanti-interleukin-17 therapy: a case series (BAD 2019) – Jul 11, 2019 – Abstract #P038; “A woman in her late 20s presented with severe psoriasis vulgaris, who had failed to respond adequately to phototherapy, methotrexate, adalimumab and ustekinumab. We hypothesize that inhibition of the axis by secukinumab may be responsible for a shift towards the opposing Th2 cell axis, subsequent barrier disruption and eczema development. Ongoing postmarketing pharmacovigilance is important and further investigation is required to establish a causal link and understand the pathogenesis.”

 

Stelara (ustekinumab) / J&J; BMS-986165 / BMS
Efficacy and Safety of BMS-986165 Compared with Placebo in Subjects with Active Psoriatic Arthritis (PsA) A BMS-986165 placebóhoz viszonyított hatásossága és biztonságossága aktív artritisz pszoriatikában (PsA) szenvedő betegeknél (clinicaltrialsregister.eu) – Jul 9, 2019 – P2; N=180; Ongoing; Sponsor: Bristol-Myers Squibb International Corporation

 

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

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Weekly Top News – Psoriasis – July 8, 2019

July 8, 2019

bimekizumab (UCB4940) / UCB
BE VITAL: A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 5, 2019 – P3; N=1045; Not yet recruiting; Sponsor: UCB Biopharma S.P.R.L.

 

Enstilar (calcipotriene/betamethasone dipropionate) / Leo Pharma
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris (clinicaltrials.gov) – Jul 5, 2019 – P3; N=722; Completed; Sponsor: LEO Pharma; Active, not recruiting –> Completed

 

mirikizumab (LY3074828) / Eli Lilly
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2) (clinicaltrials.gov) – Jul 5, 2019 – P3; N=1443; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting –> Active, not recruiting

 

Taltz (ixekizumab) / Eli Lilly
Taltz pricing: Wholesale acquisition cost of $5,162/Injection (J.P. Morgan) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67530491; Page no: 20; REPORT TITLE: “European Pharmaceuticals: Weekly chartbook: TRx for week ending June 14th”; AUTHOR: Vosser, Richard, et al; DATE: 06/24/2019

 

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Completition of P3 trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) for moderate-to-severe plaque psoriasis by late-2020 (RBC Capital Markets (Canada)) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67512769; Page no: 22; REPORT TITLE: “Game Changers: Disruptive forces in biotech: 2H19 edition (v3.0)”; AUTHOR: Abrahams, Brian, et al; DATE: 06/19/2019

 

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.”

 

Otezla (apremilast) / Celgene
Otezla sales projection: $2.3B (consensus: $2.5B) in 2024 (Guggenheim) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67532791; Page no: 1; 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

 

Taltz (ixekizumab) / Eli Lilly
Eli Lilly Korea gains further reimbursement for psoriasis treatment Taltz (Korea Biomedical Review) – Jul 1, 2019 – “The Korean branch of Eli Lilly said that it had gained additional reimbursement for its psoriasis treatment Taltz (Ingredient: ixekizumab) for treating active and progressive psoriatic arthritis from the Ministry of Health and Welfare.”

 

PF-06700841 / Pfizer
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2019 – P2b; N=196; Recruiting; Sponsor: Pfizer; Not yet recruiting –> Recruiting

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Weekly Top News – Psoriasis – July 1, 2019

July 2, 2019

Cosentyx (secukinumab) / Novartis
Cosentyx clinical trial estimate: Data from P3 EXCEED trial (NCT02745080) for psoriatic arthritis in 2020 (J.P. Morgan) – Jun 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67502119; Page no: 1; REPORT TITLE: “European Pharma & Biotech : EULAR 2019 wrap up: Key takeaways for Novartis, Roche, GSK, Galapagos, UCB and MorphoSys”; AUTHOR: Quigley, James, et al; DATE: 06/17/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
A Clinical Trial of Tildrakizumab in Pediatric Subjects With Moderate to Severe Chronic Plaque Psoriasis(clinicaltrials.gov) – Jun 25, 2019 – P2/3; N=120; Not yet recruiting; Sponsor: Sun Pharma Global FZE

 

Tremfya (guselkumab) / J&J
G-PLUS: A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis(clinicaltrials.gov) – Jun 26, 2019 – P3b; N=105; Not yet recruiting; Sponsor: Janssen-Cilag Ltd.

 

Cosentyx (secukinumab) / Novartis
FUTURE5: Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis (clinicaltrials.gov) – Jun 28, 2019 – P3; N=997; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed

 

Otezla (apremilast) / Celgene
Bristol-Myers Squibb plans to sell Celgene’s Otezla in attempt to expedite acquisition (BioSpace) – Jun 24, 2019 – “As the U.S. Federal Trade Commission (FTC) reviews Bristol-Myers Squibb’s acquisition of Celgene, Bristol-Myers indicates it plans to divest Celgene’s psoriasis and psoriatic arthritic drug Otezla (apremilast)….The divestiture is apparently in response to FTC concerns over the merger. The companies expect the deal to close at the end of this year or in early 2020.”

 

Duobrii (halobetasol/tazarotene) / Bausch Health
Bausch Health announces U.S. launch of Duobrii (halobetasol propionate and tazarotene) lotion 0.01%/0.045% for plaque psoriasis in adults (PRNewswire) – Jun 25, 2019 – “Bausch Health Companies…and its dermatology business, Ortho Dermatologics…today announced that DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, will be available commercially to health care professionals starting this week….DUOBRII Lotion is priced at $825 for a supply of a 100-gram tube…through the company’s access program, most eligible, commercially insured patients will have a co-pay as little as $25.”

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Weekly Top News – Psoriasis – June 24, 2019

June 24, 2019

ANB019 / AnaptysBio
ANB019: Top-line data from P2 GALLOP trial (NCT03619902) for generalized pustular psoriasis in mid-2019 (Jefferies 2019 Healthcare Conference, AnaptysBio) – Jun 19, 2019

 

MP1032 / MetrioPharm
Last patient last visit in MetrioPharm’s phase II clinical trial in psoriasis (MetrioPharm Press Release) – Jun 17, 2019 – “MetrioPharm AG, a pharmaceutical development company, announces that the last patient was now examined during the currently ongoing clinical psoriasis Phase II study (Last Patient Last Visit)….The team at MetrioPharm is now awaiting the validation of the data. Afterwards we will immediately start the data analysis. We are expecting the study’s final results within the next few months.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $25M (consensus: $10M) for Q2 2019 and $215M (consensus: $147M) for FY2019 (UBS) – Jun 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67498196; Page no: 1; REPORT TITLE: “AbbVie Inc – First read: AbbVie “Weekly Skyrizi tracker” (neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 06/14/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 17, 2019 – P3; N=150; Recruiting; Sponsor: AbbVie; Trial primary completion date: Dec 2019 –> Apr 2020

 

Otezla (apremilast) / Celgene
Otezla share value: $15/share to Celgene (Barclays) – Jun 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458401; Page no: 3; REPORT TITLE: ” CELG/BMY – Thoughts on ozanimod NDA acceptance”; AUTHOR: Meacham, Geoffrey, et al; DATE: 06/06/2019

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
EULAR data will support new indication for brodalumab (The Pharma Letter) – Jun 17, 2019 – Subscription required

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Weekly Top News – Psoriasis – June 17, 2019

June 17, 2019

benvitimod (GSK2894512) / Roivant
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002) (clinicaltrials.gov) – Jun 12, 2019 – P3; N=500; Recruiting; Sponsor: Dermavant Sciences GmbH

 

Taltz (ixekizumab) / Eli Lilly
Lilly to present 5-year sustained efficacy and safety results for Taltz (ixekizumab) in patients with plaque psoriasis at the World Congress of Dermatology (Eli Lilly Press Release) – Jun 11, 2019 – “Eli Lilly and Company…announced today the company will present positive, five-year Phase 3 data for Taltz® (ixekizumab). Patients with moderate- to severe plaque psoriasis who continued to receive Taltz maintained high levels of skin clearance with no unexpected safety outcomes…will be presented at the World Congress of Dermatology (WCD) in Milan, Italy on June 11….Four-year data from UNCOVER-3 will also be presented at the WCD….Later this year, Lilly plans to announce the results from IXORA-R, a clinical trial designed to evaluate superiority between Taltz and Tremfya® (guselkumab) in adult patients with moderate- to severe plaque psoriasis.”

 

Cosentyx (secukinumab) / Novartis
FUTURE 2: Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis (clinicaltrials.gov) – Jun 12, 2019 – P3; N=399; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial primary completion date: May 2014 –> Jan 2019

 

Tremfya (guselkumab) / J&J
Janssen reports top-line phase 3 results for Tremfya (guselkumab) in adults with active psoriatic arthritis(Businesswire) – Jun 14, 2019 – P3, N=383, DISCOVER-1 (NCT03162796); P3, N=741; DISCOVER-2 (NCT03158285); Sponsor: Janssen Research & Development; “The Janssen Pharmaceutical…today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies…in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent…Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.”

 

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) vs. Humira (adalimumab) in a head-to-head (SPIRIT-H2H) superiority study in patients with active psoriatic arthritis at the European Congress of Rheumatology (Eli Lilly Press Release) – Jun 14, 2019 – P4, N=566; SPIRIT-H2H (NCT03151551); Sponsor: Eli Lilly and Company; Eli Lilly and Company…announced today that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study in patients with active psoriatic arthritis (PsA) as a late-breaking abstract at the European Congress of Rheumatology (EULAR) in Madrid, Spain on June 15….The primary endpoint of the study was superiority for Taltz compared to Humira…achieved a reduction by at least 50 percent in disease activity as defined by the American College of Rheumatology (ACR50) and complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI 100)….No new safety signals were detected.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
New two-year data at the 24th World Congress of Dermatology shows Skyrizi (risankizumab) maintains complete skin clearance (AbbVie Press Release) – Jun 11, 2019 – P3, N=507; IMMHance (NCT02672852); Sponsor: Abbvie; “AbbVie…today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94….These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of SKYRIZI in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan….No new safety findings observed at two years (104 weeks)…”

 

Cosentyx (secukinumab) / Novartis
Novartis Cosentyx first to show efficacy in all key manifestations of psoriatic arthritis (GlobeNewswire) – Jun 12, 2019 – P3b, N=502; MAXIMISE(NCT02721966); Sponsor: Novartis Pharmaceuticals; “Novartis…announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. Rapid onset of relief was seen as early as week four, with the trial demonstrating a favorable safety profile consistent with previous clinical trials…These data…will be presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.”

 

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 10, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces late-breaking phase 2 data showing potential of Ilumya (tildrakizumab-asmn) to improve joint and skin symptoms of psoriatic arthritis (PRNewswire) – Jun 14, 2019 – “Sun Pharmaceutical…today announced interim results from a Phase 2 study of…ILUMYA (tildrakizumab-asmn) in patients with active psoriatic arthritis that was presented in a late-breaking oral presentation at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (abstract #LB-0002). The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study….We are now exploring a possible Phase 3 trial for psoriatic arthritis with regulatory authorities.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx provides long lasting inhibition of radiographic progression in psoriatic arthritis, new Novartis data show (GlobeNewswire) – Jun 12, 2019 – P3, N=998; FUTURE 5 (NCT02404350); Sponsor: Novartis Pharmaceuticals; “Novartis…announced today new data from the FUTURE 5 trial showing no radiographic progression (mTSS)

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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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