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Category: Psoriasis

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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Weekly Top News – Psoriasis – September 2, 2019

September 2, 2019

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

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.2B in FY2020 (CFRA) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873275; Page no: 1; REPORT TITLE: “Amgen Inc- Otezla deal highly accretive – Provides synergy and accelerates rev/EPS growth”; AUTHOR: Werber, Yaron, et al; DATE: 08/26/2019

 

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

 

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

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.2B in 2020, $3.1B peak and guidance of $1.9B in 2019 (J.P. Morgan) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67885180; Page no: 1; REPORT TITLE: “Amgen Inc- Amgen Inc: Updating model for Otezla acquisition; It helps but additional levers needed to further boost growth outlook”; AUTHOR: Kasimov, Cory, et al; DATE: 08/28/2019

 

Otezla (apremilast) / Amgen
Otezla: Expiry of patent in US in 2028 (Amgen) – Aug 31, 2019 – Amgen to Acquire Otezla  
[Screenshot]

 

Otezla (apremilast) / Amgen
Otezla sales projection: $3.7B in 2026 (Cantor Fitzgerald) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873189; Page no: 1; REPORT TITLE: “Amgen Inc- Post Enbrel, Amgen keeps on trucking with a new I&I add to their portfolio”; AUTHOR: Research Department; DATE: 08/26/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9B in 2019 and $2.2B in 2020 (Jefferies) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873157; Page no: 1, 3; REPORT TITLE: “Amgen Inc- Smart deal and very accretive…we’d buy the dip today; Reiterate BUY”; AUTHOR: Yee, Michael, et al; DATE: 08/26/2019

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Weekly Top News – Psoriasis – August 26, 2019

August 26, 2019

Cosentyx (secukinumab) / Novartis
Cosentyx clinical trial estimate: Data from P3 BE RADIANT trial (NCT03536884) for psoriasis in Q2 2020 (Barclays) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67816038; Page no: 1; REPORT TITLE: “NOVN/UCB: One back for the IL-17s? Kind of…”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 08/13/2019

 

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

 

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

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi pricing: Wholesale acquisition cost of $59,000/year for maintenance dosing (UBS) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67836265; Page no: 1; REPORT TITLE: “AbbVie Inc- First read: AbbVie “Upadacitinib approval mostly in-line w/ expectations””; AUTHOR: Jacob, Navin, et al; DATE: 08/16/2019

 

Taltz (ixekizumab) / Eli Lilly
Taltz sales projection: $1.4B in 2019 (Cantor Fitzgerald) – Aug 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67814539; Page no: 1; REPORT TITLE: “Eli Lilly & Co Lly Standing “Taltz” This morning with positive head to head data”; AUTHOR: Research Department, et al; DATE: 08/13/2019

 

Otezla (apremilast) / Celgene
Otezla TRx: 13,093 in second week of August 2019; Otezla NRx: 4,528 in second week of August 2019 (RBC Capital Markets (Canada)) – Aug 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67794724; Page no: 3; REPORT TITLE: “Noteworthy wkly script trends (HIV, HCV, MS, CGRP, TKI, PCSK9, Otezla): RBC Coverage W/E 8/2 – Wk 5 of 3Q”; AUTHOR: Abrahams, Brian, et al; DATE: 08/09/2019

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Weekly Top News – Psoriasis – August 12, 2019

August 12, 2019

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Data from P3 trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) for moderate-to-severe plaque psoriasis in late 2020 (William Blair) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531579; Page no: 22; REPORT TITLE: “Bristol-Myers Squibb Co.: BMY: CheckMate-459 failure and deal closing delay for Otezla divestiture a double hit to sentiment”; AUTHOR: Phipps, Matt, et al; DATE: 06/24/2019

 

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

 

bimekizumab (UCB4940) / UCB
Bimekizumab launch estimate: For psoriatic arthritis in 2022 (Kepler Cheuvreux) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67604813; Page no: 19; REPORT TITLE: “UCB SA – Q&A report | UCB | Buy | What can really get UCB shares moving?”; AUTHOR: Evans, David, et al; DATE: 07/21/2019

 

Efleira (netakimab) / Biocad
Efleira clinical trial estimate: Initiation of pivotal trial in Europe for psoriasis in Q4 2019(GlobalData) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 66555904; Page no: 22; REPORT TITLE: “Biocad”; AUTHOR: GlobalData; DATE: 07/22/2019

 

Tremfya (guselkumab) / J&J
Tremfya pricing: Wholesale acquisition cost of $10,859/Injection (J.P. Morgan) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67760273; Page no: 21; REPORT TITLE: “European Pharmaceuticals: Weekly chartbook: trx for week ending July 26th “; AUTHOR: Vosser, Richard, et al; DATE: 08/05/2019

 

Tremfya (guselkumab) / J&J
MorphoSys AG reports second quarter 2019 financial results (Market Watch) – Aug 6, 2019 – “An increasing royalty stream from Tremfya further strengthens our cash position and we are confident that there will be other compounds that follow Tremfya’s market entry in the future….Revenues also included an estimate of royalties on net sales of Tremfya amounting to EUR 7.1 million (estimate only since royalties for Q2 2019 had not been reported by Janssen as of the balance date)….Further phase 3 trials of Tremfya conducted by Janssen in psoriatic arthritis and a potential submission of a BLA planned for later this year as communicated by Janssen.”

 

Otezla (apremilast) / Celgene
Otezla sales projection: $2.7B in 2022 (Cowen & Co) – Aug 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 67713313; Page no: 2; REPORT TITLE: “Celgene Corp – Solid Q2 – bb2121 filing likely early ’20, not clear if KarMMa data at ASH”; AUTHOR: Werber, Yaron, et al; DATE: 07/30/2019

 

ANB019 / AnaptysBio
AnaptysBio announces second quarter 2019 financial results and provides pipeline updates(AnaptysBio Press Release) – Aug 8, 2019 – “The Company is conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top-line data anticipated in the first half of 2020….Research and development expenses were $27.4 million and $48.0 million for the three and six months ended June 30, 2019, compared to $10.6 million and $22.4 million for the three and six months ended June 30, 2018. The increase was due primarily to continued advancement of the Company’s…ANB019 clinical programs…”

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Weekly Top News – Psoriasis – August 5, 2019

August 5, 2019

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Brodalumab: Regulatory decision in Asia for psoriasis in 2020 (Kyowa Hakko Kirin Pharma) – Aug 2, 2019 – Q2 2019 Results  
[Screenshot]

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces regulatory filing of tildrakizumab in Japan; stock down 1.5% (IIFL) – Aug 1, 2019 – “The co. announced that one of its wholly owned subsidiaries has filed an application for Manufacturing and Marketing Authorization of Tildrakizumab for moderate-to-severe psoriasis and psoriatic arthritis with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.”

 

PF-06700841 / Pfizer
A PHASE 2B DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM IN PARTICIPANTS WITH CHRONIC PLAQUE PSORIASIS (clinicaltrialsregister.eu) – Aug 1, 2019 – P2; N=240; Ongoing; Sponsor: Pfizer Inc.

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite signs agreement with Kyongbo Pharm for the distribution in South Korea of piclidenoson in the treatment of psoriasis (Can-Fite Biopharma Press Release) – Aug 1, 2019 – “Can-Fite BioPharma…today announced it has signed a distribution agreement with Kyongbo Pharm Co., Ltd., to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of psoriasis in South Korea, upon receipt of regulatory approvals….Up to $4,000,000 in upfront and milestone payments, plus a transfer price for delivering finished product…”

 

ANB019 / AnaptysBio
ANB019 US pricing projection: $50,000/year (Credit Suisse) – Jul 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407578; Page no: 6; REPORT TITLE: “Anaptysbio Inc ANAB: Bull versus bear debate”; AUTHOR: Auster, Martin, et al; DATE: 05/29/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $4.9B in 2023 (Kepler Cheuvreux) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67665572; Page no: 8; REPORT TITLE: “Novartis AG – Espresso note | Novartis | Hold | Great business, fair value: downgrade to Hold”; AUTHOR: Evans, David, et al; DATE: 07/23/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall; Skilarence (dimethyl fumarate) / Almirall
Almirall H1 2019 – Continued strong business momentum while reinforcing pipeline (Almirall Press Release) – Jul 29, 2019 – “Research & Development costs were €43.9 MM in H1, representing 10.2% of Net Sales (vs. 9.7% of Net Sales in Q1 2019 and 10.4% in H1 2018) due to Phase IV studies for Skilarence® and Ilumetri….Rollout of Ilumetri is ongoing, achieving a solid unit sales growth (+63% unit growth) during Q2 2019 in Germany, the UK and some Nordic Countries….Rollout continues in H2 with The Netherlands, Austria, Spain, Ireland, Poland and additionally Switzerland, following positive recommendations by Swissmedic….Skilarence® has delivered €16 MM of sales, representing over 102% year-on-year Net Sales growth vs. H1 2018.”

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Weekly Top News – Psoriasis – July 29, 2019

July 30, 2019

bimekizumab (UCB4940) / UCB
Bimekizumab: Data from P3 BE SURE trial (NCT03412747) for psoriasis in Q4 2019 (UCB) – Jul 26, 2019 – H1 2019 Results  
[Screenshot]

 

bimekizumab (UCB4940) / UCB
UCB half year report 2019: UCB’s strong performance enables continued investment into future growth drivers (PharmiWeb) – Jul 25, 2019 – “In March and April, the second and the third phase 3 program with bimekizumab – in psoriatic arthritis and in axial Spondyloarthitis – were initiated, slightly earlier than planned. First topline results are expected at the end of 2021.”

 

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

 

ANB019 / AnaptysBio
ANB019 US pricing projection: $50,000/year (Credit Suisse) – Jul 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407578; Page no: 6; REPORT TITLE: “Anaptysbio Inc ANAB: Bull versus bear debate”; AUTHOR: Auster, Martin, et al; DATE: 05/29/2019

 

Otezla (apremilast) / Celgene
Bristol-Myers confident with on-time OK of Celgene deal in Europe (SeekingAlpha) – Jul 23, 2019 – “BMY has agreed to divest CELG’s Otezla (apremilast) in order to receive a timely thumbs-up in the U.S.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $30M in FY2020, $110M in FY2021 and $475M peak (Morgan Stanley)- Jul 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67624534; Page no: 22, 12; REPORT TITLE: “Sun Pharmaceutical Industries: Set to shine – double upgrade to OW”; AUTHOR: Baisiwala, Sameer, et al; DATE: 07/14/2019

Otezla (apremilast) / Celgene
Otezla sales projection: $1.5B in US and $400M ex-US in 2019 (Jefferies) – Jul 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 67603525; Page no: 31; REPORT TITLE: “Q2 EPS thoughts: AMGN, BIIB, CELG, GILD, ALXN, REGN, VRTX, AMRN and lots more”; AUTHOR: Yee, Michael, et al; DATE: 07/09/2019

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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  
[Screenshot]

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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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