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Pharma news roundup and Larvol updates

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Category: Psoriasis

Weekly Top News – Psoriasis– January 20, 2020

January 20, 2020

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
New head-to-head phase 3 data show Skyrizi (risankizumab) superior to Cosentyx (secukinumab) across primary and all ranked secondary endpoints in adults with moderate to severe plaque psoriasis at 52 weeks (PRNewswire) – Jan 14, 2020 – P3, N=327; NCT03478787; Sponsor: AbbVie; “AbbVie…today announced that SKYRIZI™ met both primary and all ranked secondary endpoints, including superiority at week 52, versus Cosentyx® in a head-to-head Phase 3 study….’In this study, SKYRIZI showed superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at week 52’….Current safety data available demonstrated that the safety profile of SKYRIZI was consistent with that observed in previously reported studies, with no new safety signals observed through week 52.

 

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Detailed data from P3 trials BE VIVID (NCT03370133) and BE READY (NCT03410992) for moderate to severe plaque psoriasis at AAD (March 20-24, 2020) – Jan 17, 2020 – A subscription to Thomson ONE is required to gain full access to report 68594462; Page no: 206; REPORT TITLE: “EU Pharma & Biotech: Sector set to top the medal table in an Olympic year”; AUTHOR: Vosser, Richard, et al; DATE: 01/06/2020

 

Stelara (ustekinumab) / J&J; bimekizumab (UCB4940) / UCB
BE VIVID: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jan 18, 2020 – P3; N=570; Completed; Sponsor: UCB Biopharma S.P.R.L.; Active, not recruiting –> Completed

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
IMMpact2: A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (clinicaltrials.gov) – Jan 13, 2020 – P3; N=444; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting; Trial primary completion date: Jan 2021 –> Jun 2020

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE) (clinicaltrials.gov) – Jan 15, 2020 – P4; N=160; Recruiting; Sponsor: Almirall, S.A.

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Weekly Top News – Psoriasis– January 13, 2020

January 13, 2020

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Presentation of full data from P3 BE SURE trial (NCT03412747) for psoriasis at ESDR (September 02-September 05, 2020) (J.P. Morgan) – Jan 9, 2020 – A subscription to Thomson ONE is required to gain full access to report 68594462; Page no: 129; REPORT TITLE: “EU Pharma & Biotech: Sector set to top the medal table in an Olympic year”; AUTHOR: Vosser, Richard, et al; DATE: 1/06/2020

 

Cosentyx (secukinumab) / Novartis
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site (clinicaltrials.gov) – Jan 9, 2020 – P3; N=204; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed

 

Qletli (adalimumab biosimilar) / Bio-Thera Solutions
Bio-Thera Solutions launches first commercial product, Qletli (格乐立), in China (Businesswire) – Jan 10, 2020 – “Bio-Thera Solutions, Ltd…today announced that QLETLI® (格乐立®), a biosimilar to Humira® (adalimumab), is now available in China. QLETLI® (格乐立®), the first adalimumab biosimilar approved by the China National Medical Products Administration (NMPA), is authorized for the treatment of three autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.35B by 2020 (GlobalData) – Jan 7, 2020 – A subscription to Thomson ONE is required to gain full access to report 67598474 Page no: 66; REPORT TITLE: ” Cipher Pharmaceuticals Inc (CPH) – Financial analysis review”; AUTHOR: GlobalData ; DATE: 12/30/2019

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Weekly Top News – Psoriasis– January 6, 2020

January 6, 2020

Stelara (ustekinumab) / J&J
Stelara patent expiry: January 2024 in EU (Barclays) – Jan 2, 2020 – A subscription to Thomson ONE is required to gain full access to report 68519497; Page no: 8; REPORT TITLE: “Johnson & Johnson: Last minute gift idea? JNJ; Upgrade to overweight”; AUTHOR: Stewart, Kristen, et al; DATE: 12/19/2019

 

AVT02 (adalimumab biosimilar) / Alvotech, Cipla; Humira (adalimumab) / Eisai, AbbVie
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jan 3, 2020 – P3; N=413; Active, not recruiting; Sponsor: Alvotech Swiss AG; Recruiting –> Active, not recruiting; Initiation date: Feb 2019 –> Dec 2019

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Weekly Top News – Psoriasis– December 30, 2019

December 30, 2019

Otezla (apremilast) / Amgen
Otezla US regulatory estimate: Approval for mild to moderate psoriasis setting by 2022 (Credit Suisse) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68489223; Page no: 4; REPORT TITLE: “U.S. Biotechnology: 2020 outlook: Reevaluating our coverage ahead of the new year”; AUTHOR: Research Department; DATE: 12/13/2019

 

Cosentyx (secukinumab) / Novartis
INVIGORATE 2: Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Dec 24, 2019 – P3; N=380; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

 

Tremfya (guselkumab) / J&J
China regulator approves imports of J&J’s Tremfya (The New York Times) – Dec 27, 2019 – “China has approved imports of Johnson & Johnson’s Tremfya (guselkumab), the National Medical Products Administration said in a notice on Friday. The drug will be used to treat moderate to severe plaque psoriasis in adults who are suitable for systemic therapy…”

 

Otezla (apremilast) / Amgen
Otezla pricing projection: $3,400/month for mild to moderate psoriasis setting (Credit Suisse) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68489223; Page no: 4; REPORT TITLE: “U.S. Biotechnology: 2020 outlook: Reevaluating our coverage ahead of the new year”; AUTHOR: Research Department; DATE: 12/13/2019

 

Otezla (apremilast) / Amgen
Otezla WW sales projection: $3.4B by 2024 (Credit Suisse) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68489223; Page no: 4; REPORT TITLE: “U.S. Biotechnology: 2020 outlook: Reevaluating our coverage ahead of the new year”; AUTHOR: Research Department; DATE: 12/13/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $4.8B peak in 2027 (Morgan Stanley) – Dec 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 68506536; Page no: 4; REPORT TITLE: “Amgen Inc- Initiating coverage: Amgen Inc.: Base business optimism drives sentiment into 2020; Resume at overweight”; AUTHOR: Harrison, Matthew, et al; DATE: 12/17/2019

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Weekly Top News – Psoriasis– December 23, 2019

December 23, 2019

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Top-line data from P3 trials OASIS-1 (NCT03482011) and OASIS-2 (NCT03535194) for psoriasis in 2020 (Eli Lilly) – Dec 18, 2019 – 2020 Financial Guidance Call 
[Screenshot]

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya regulatory estimate: Approval by 2023 in China for psoriasis – Dec 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 68380316; Page no: 7; REPORT TITLE: “China medical system: Time to price in some pipeline value; Raise PT “; AUTHOR: Hu, Yolanda, et al; DATE: 11/21/2019

 

Stelara (ustekinumab) / J&J
Stelara: “The Committee discussed the issues identified in this application relating to some quality and clinical aspects as well as the RMP [extension of indication to include a new population for Stelara solution for injection in children aged 6 to 12 years with moderate to severe psoriasis based on the results of study CNTO1275PSO3013].” (EMEA) – Dec 20, 2019 – CHMP Final Minutes for the meeting on 14-17 October 2019: “The Committee adopted a request for supplementary information with a specific timetable.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
SAIL: Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice (clinicaltrials.gov) – Dec 18, 2019 – P; N=430; Recruiting; Sponsor: Almirall, S.A.

 

Olumiant (baricitinib) / Incyte, Eli Lilly; Taltz (ixekizumab) / Eli Lilly
Lilly announces 2020 financial guidance, updates 2019 guidance (Eli Lilly Press Release) – Dec 17, 2019 – “The company anticipates 2020 revenue between $23.6 billion and $24.1 billion. Meeting its 2020 revenue forecast would allow the company to achieve or exceed the 7 percent revenue CAGR target it previously communicated for the time period 2015 – 2020. Revenue growth is expected to be driven by volume from key growth products including…Taltz®…Olumiant®, Emgality…Reyvow.”

 

Taltz (ixekizumab) / Eli Lilly; Cosentyx (secukinumab) / Novartis; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab (clinicaltrials.gov) – Dec 16, 2019 – P3b; N=250; Recruiting; Sponsor: AbbVie; N=365 –> 250

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $175M by FY2022 (Nomura) – Dec 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 68399991; Page no: 1; REPORT TITLE: “Sun Pharmaceutical Industries (SUNP IN, Buy) – Retain buy with reduced TP of INR 525”; AUTHOR: Mukherjee, Saion, et al; DATE: 11/25/2019

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Weekly Top News – Psoriasis– December 16, 2019

December 16, 2019

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Data from P2 trial (NCT03881059) for PsA in April 2020 (Morgan Stanley) – Dec 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68264181; Page no: 8; REPORT TITLE: “Novartis AG- Pharmaceuticals: Specialist prescribing dynamics: Focus on immunology”; AUTHOR: Purcell, Mark, et al; DATE: 11/05/2019

 

BMS-986165 / BMS
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea (clinicaltrials.gov) – Dec 11, 2019 – P3; N=180; Recruiting; Sponsor: Bristol-Myers Squibb; Not yet recruiting –> Recruiting

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $175M by FY2022 (Nomura) – Dec 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 68399991; Page no: 1; REPORT TITLE: “Sun Pharmaceutical Industries (SUNP IN, Buy) – Retain buy with reduced TP of INR 525”; AUTHOR: Mukherjee, Saion, et al; DATE: 11/25/2019

 

bimekizumab (UCB4940) / UCB
Bimekizumab sales projection: €1.3B peak by 2027 and €764M in 2024 (Kepler Cheuvreux) – Dec 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68117973; Page no: 1; REPORT TITLE: “UCB SA- Espresso note | UCB | Buy | First success for key asset bimekizumab”; AUTHOR: Evans, David, et al; DATE: 10/17/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $3.4B in 2025 (Oppenheimer) – Dec 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 68429540; Page no: 1; REPORT TITLE: “Amgen Inc – Recent events bolster our Outlook”; AUTHOR: Research Department; DATE: 12/01/2019

 

Stelara (ustekinumab) / J&J; Tremfya (guselkumab) / J&J
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project (clinicaltrials.gov) – Dec 13, 2019 – P=N/A; N=200; Recruiting; Sponsor: University of California, San Diego; Active, not recruiting –> Recruiting; N=107 –> 200; Trial completion date: Jul 2022 –> Dec 2025; Trial primary completion date: Nov 2020 –> Dec 2024

 

Otezla (apremilast) / Amgen
APPROPIATE: Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain (clinicaltrials.gov) – Dec 13, 2019 – P=N/A; N=153; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting; Trial primary completion date: Jul 2019 –> Feb 2020

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
IMMpact2: A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (clinicaltrials.gov) – Dec 11, 2019 – P3; N=420; Recruiting; Sponsor: AbbVie; Trial completion date: Dec 2024 –> May 2024

 

bimekizumab (UCB4940) / UCB
Bimekizumab share value projection: €17/share to UCB (Kepler Cheuvreux) – Dec 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68117973; Page no: 1; REPORT TITLE: “UCB SA- Espresso note | UCB | Buy | First success for key asset bimekizumab”; AUTHOR: Evans, David, et al; DATE: 10/17/2019

 

BMS-986165 / BMS; Stelara (ustekinumab) / J&J
Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) (clinicaltrials.gov) – Dec 11, 2019 – P2; N=180; Active, not recruiting; Sponsor: Bristol-Myers Squibb; Recruiting –> Active, not recruiting

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Weekly Top News – Psoriasis – December 9, 2019

December 9, 2019

bimekizumab (UCB4940) / UCB
Bimekizumab phase 3 psoriasis study demonstrates superiority versus Humira (PRNewswire) – Dec 6, 2019 – P3, N=478; BE SURE (NCT03412747); Sponsor: UCB Biopharma; “UCB…announced positive results from the Phase 3 active-controlled BE SURE study. BE SURE compared…bimekizumab to the TNF inhibitor adalimumab in the treatment of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-primary endpoints at week 16, demonstrating superiority of bimekizumab to adalimumab….The BE SURE study also met all of its ranked secondary endpoints with statistical significance…”

 

ANB019 / AnaptysBio
ANB019 clinical trial estimate: Top-line data from P2 POPLAR trial (NCT03633396) for palmoplantar pustulosis in H1 2020 (Wedbush) – Dec 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 68304667; Page no: 2, 3; REPORT TITLE: “Anaptybio Inc- D/g to Neutral; Etokimab miss disappointing, but ANAB’s still better than cash”; AUTHOR: Nirengarten, David, et al; DATE: 11/08/2019

 

Avsola (infliximab-axxq) / Amgen
FDA approves Amgen’s Avsola (infliximab-axxq), for the same indications as Remicade (infliximab) (Amgen Press Release) – Dec 6, 2019 – “Amgen…announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)…AVSOLA, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which included comparative analytical, nonclinical and clinical data.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission for pediatric psoriasis in 2019 (Novartis) – Dec 6, 2019 – R&D Day: Regulatory submission for psoriasis in 2020; Regulatory submission for spondyloarthritis in 2022; Regulatory submission for ankylosing spondylitis beyond 2023 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx pricing: Wholesale acquisition cost of $5,179/Injection (J.P. Morgan) – Dec 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68429567; Page no: 20; REPORT TITLE: “Pharmaceuticals weekly: Weekly chartbook: TRx for week ending November 22nd and October IQVIA sales data”; AUTHOR: Vosser, Richard, et al; DATE: 12/02/2019

 

Taltz (ixekizumab) / Eli Lilly
Taltz pricing: Wholesale acquisition cost of $5,162/Injection (J.P. Morgan) – Dec 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68429567; Page no: 20; REPORT TITLE: “Pharmaceuticals weekly : Weekly chartbook: TRx for week ending November 22nd and October IQVIA sales data”; AUTHOR: Vosser, Richard, et al; DATE: 12/02/2019

 

Tremfya (guselkumab) / J&J
Tremfya pricing: Wholesale acquisition cost of $10,859/Injection (J.P. Morgan) – Dec 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68429567; Page no: 20; REPORT TITLE: “Pharmaceuticals weekly : Weekly chartbook: TRx for week ending November 22nd and October IQVIA sales data”; AUTHOR: Vosser, Richard, et al; DATE: 12/02/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Korea Food and Drug Administration approves moderate to severe plaque psoriasis treatment [Google Translation] (The Herald Business – Herald Corp) – Dec 4, 2019 – “The Food and Drug Administration approved the Skyrich Freefield Syringe (American Risankizumab) for severe psoriasis treatment of Abbi Korea.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9-2B in 2019 and $2.2B in 2020 (Jefferies) – Dec 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 68384328; Page no: 1; REPORT TITLE: “Amgen Inc- Raising guidance on Otezla accretion even earlier “; AUTHOR: Yee, Michael, et al; DATE: 11/21/2019

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
A Phase 4 Clinical Study of Brodalumab (clinicaltrials.gov) – Dec 3, 2019 – P4; N=138; Completed; Sponsor: Kyowa Kirin Co., Ltd.

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Weekly Top News – Psoriasis – December 2, 2019

December 2, 2019

BMS-986165 / BMS
Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis (clinicaltrialsregister.eu) – Nov 26, 2019 – P3; N=1950; Ongoing; Sponsor: Bristol-Myers Squibb International Corporation

 

Otezla (apremilast) / Amgen
A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Nov 25, 2019 – P3b; N=140; Not yet recruiting; Sponsor: Celgene

 

Taltz (ixekizumab) / Eli Lilly
A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3) (clinicaltrials.gov) – Nov 25, 2019 – P3; N=1346; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

BMS-986165 / BMS
POETYK-PSO-2: An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) – Nov 27, 2019 – P3; N=1000; Active, not recruiting; Sponsor: Bristol-Myers Squibb; Recruiting –> Active, not recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Huge savings as more drugs added to PBS (Nine News) – Dec 1, 2019 – “A series of drugs are being added to the Pharmaceutical Benefits Scheme…Patients with moderate to severe plaque psoriasis…will have access to a new drug Skyrizi (risankizumab)….More patients with severe eosinophilic asthma will also have access to the currently listed asthma medicines Fasenra (benralizumab) and Nucala (mepolizumab) after the access criteria was expanded.”

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Siliq pricing: $42,000/year in US (H.C. Wainwright & Co) – Nov 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68281151; Page no: 27; REPORT TITLE: “Dynamic drug delivery for Oligos; Initiating at Buy and $8.00 price target”; AUTHOR: Selvaraju, Raghuram, et al; DATE: 11/06/2019

 

Otezla (apremilast) / Amgen
Otezla: Newly added patents in Orange Book (Orange Book) – Nov 27, 2019 – Expiry on March 19, 2023 and May 29, 2034 
[Screenshot]

 

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) – Nov 29, 2019 – P3; N=157; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting

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Weekly Top News – Psoriasis – November 25, 2019

November 25, 2019

Otezla (apremilast) / Amgen
A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Nov 25, 2019 – P3b; N=140; Not yet recruiting; Sponsor: Celgene

 

BMS-986165 / BMS
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea (clinicaltrials.gov) – Nov 18, 2019 – P3; N=180; Not yet recruiting; Sponsor: Bristol-Myers Squibb

 

Otezla (apremilast) / Amgen
Amgen completes acquisition of Otezla (apremilast) (PRNewswire) – Nov 21, 2019 – “Amgen…today announced the successful completion of its acquisition of worldwide rights to Otezla® (apremilast)…for moderate-to-severe plaque psoriasis and psoriatic arthritis. Otezla was acquired from Celgene Corporation…in connection with its previously announced merger with Bristol-Myers Squibb Company…which was completed on Nov. 20….With the closing of the Otezla acquisition, the Company is updating its overall 2019 guidance. For the full year 2019, the Company now expects total revenues in the range of $23.1 billion to $23.3 billion.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi WW sales projection: Guidance of $275M (previously $250M) in 2019 (Zacks) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68317955; Page no: 5; REPORT TITLE: “AbbVie Inc.(ABBV) Zacks company report”; AUTHOR: Research Department; DATE: 11/11/2019

 

AK101 / Akesobio
Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Nov 22, 2019 – P2b; N=280; Not yet recruiting; Sponsor: Akeso

 

Cosentyx (secukinumab) / Novartis
Cosentyx TRx trend: +26% q/q till date in Q4 2019 (J.P. Morgan) – Nov 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 68355767; Page no: 1; REPORT TITLE: “Pharmaceuticals weekly: Weekly chartbook: TRx for week ending November 8th.”; AUTHOR: Vosser, Richard, et al; DATE: 11/15/2019

 

PF-06763809 / Pfizer
Further clarification regarding the ROR-gamma project (Yahoo Finance) – Nov 20, 2019 – “The development project, PF-06763809, was run internally by Pfizer….There has been no involvement from Karo Pharma in the project nor the decision to terminate was made by Pfizer at Pfizer’s sole discretion….Karo Pharma communicated theoretical milestones of up to 200 MUSD related to the Pfizer agreement. These potential milestone payments were all related to the specific project, PF-06763809. Given the termination of PF-06763809, none of these milestone payments will materialize.”

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis (clinicaltrials.gov) – Nov 21, 2019 – P=N/A; N=3500; Enrolling by invitation; Sponsor: Bausch Health Americas, Inc.; Not yet recruiting –> Enrolling by invitation

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie’s new launches Skyrizi, Rinvoq aren’t getting enough credit: Analyst (Fierce Pharma) – Nov 22, 2019 – “Psoriasis med Skyrizi and rheumatoid arthritis therapy Rinvoq could hit $11 billion in peak sales with scripts on the way up and market access growing…Combined with the highly successful launch of Rinvoq, AbbVie could see sales of both drugs top $1 billion next year––significantly higher than consensus estimates of around $800 million….Industry watchers expect Rinvoq to hit 75% access in January 2020, way ahead of UBS’ previous estimate…”

 

Otezla (apremilast) / Amgen
DARWIN: A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice (clinicaltrials.gov) – Nov 19, 2019 – P=N/A; N=375; Recruiting; Sponsor: Celgene; Not yet recruiting –> Recruiting

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Weekly Top News – Psoriasis – November 18, 2019

November 18, 2019

bimekizumab (UCB4940) / UCB
Bimekizumab positive results confirmed in second phase 3 psoriasis study (PRNewswire) – Nov 15, 2019 – P3, N=435; BE READY (NCT03410992); Sponsor: UCB Biopharma; “UCB…announced positive results from BE READY, the second of three Phase 3 studies this year to report findings on the investigational treatment bimekizumab…This randomized withdrawal study met its co-primary endpoints….The full BE READY results will be presented at a scientific congress in 2020…UCB is now preparing for a bimekizumab submission to regulatory authorities in mid-2020 to bring this promising treatment option to people living with psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi with ok in Argentina [Google Translation] (Pharmabiz) – Nov 12, 2019 – “The ANMAT given the nod to Skyrizi to be marketed in the Argentine market….He obtained approval in Argentina from ANMAT during this November. It was only seven months after it was approved by the United States FDA.”

 

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.”

 

Humira (adalimumab) / Eisai, AbbVie; Taltz (ixekizumab) / Eli Lilly
ACR 2019: Lilly presents 52-week head-to-head (SPIRIT-H2H) data from Taltz (ixekizumab) versus Humira (adalimumab) trial in psoriatic arthritis (Eli Lilly Press Release) – Nov 12, 2019 – P3b/4, N=566; SPIRIT-H2H (NCT03151551); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today the 52-week results from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study of Taltz® (ixekizumab) versus Humira® (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). The results are being presented as a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting in Atlanta. Taltz met the primary and all major secondary endpoints of the study.”

 

Otezla (apremilast) / Amgen
Bristol-Myers Squibb receives clearance from U.S. Federal Trade Commission for Celgene acquisition (Bristol-Myers Squibb Press Release) – Nov 15, 2019 – “Bristol-Myers Squibb Company…announced today that the U.S. Federal Trade Commission (FTC) has accepted the proposed consent order in connection with the pending merger of Bristol-Myers Squibb and Celgene Corporation…thereby permitting the parties to close the transaction. As announced on August 26, 2019, Celgene entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast)….Bristol-Myers Squibb also expects the OTEZLA divestiture to be completed promptly following the closing of the merger.”

 

Otezla (apremilast) / Amgen
Zydus Cadila gets tentative USFDA approval to market arthritis drug (Business Standard) – Nov 16, 2019 – “Drug firm Zydus Cadila on Saturday said it has received a tentative approval from the US health regulator to market generic Apremilast tablets….used to treat psoriatic arthritis and moderate to severe plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $167M (consensus: $98M) in Q4 2019 (UBS) – Nov 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 68304392; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/08/2019

 

Skilarence (dimethyl fumarate) / Almirall; Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Almirall 9M 2019 business results: Continued good business momentum driven by positive uptake of recent launches (Almirall Press Release) – Nov 11, 2019 – “Skilarence® sales were of €24 MM….Ilumetri…for the treatment of adult patients with moderate-to-severe plaque psoriasis, continues the rollout. It has achieved €13 MM of net sales during the first nine months of 2019 and, in the third quarter, the product was launched in Austria, Switzerland, the Netherlands and Spain. The rollout continues in Italy, Belgium, Czech Republic and France.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $300M peak (Jefferies) – Nov 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 68296514; Page no: 1; REPORT TITLE: “Sun Pharmaceutical Industries Ltd – 2Q20: In- line quarter as strong India offset US weakness”; AUTHOR: Nahar, Piyush, et al; DATE: 11/07/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $4.1B in 2022 and $4.6B peak (Barclays) – Nov 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68241420; Page no: 1; REPORT TITLE: “NOVN/UCB: Cosentyx data takes: still struggling to EXCEED”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 11/01/2019

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