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Month: November 2019

Weekly Top News – Breast Cancer – November 11, 2019

November 11, 2019

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
EL1SSAR: A Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) – Nov 5, 2019 – P3; N=280; Not yet recruiting; Sponsor: Hoffmann-La Roche

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Second interim OS data from P3 SOPHIA trial (NCT02492711) in HER2+ metastatic breast cancer at SABCS (Dec 10- 14, 2019) (Macrogenics) – Nov 9, 2019 – Corporate Presentation 
[Screenshot]

 

llllllllll entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Launch in US for breast cancer in 2021 (Syndax) – Nov 11, 2019 – Q3 2019 Results
Launch US

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports third quarter 2019 financial results and provides clinical and business update (PRNewswire) – Nov 7, 2019 – P3, N=600; E2112 (NCT02115282); P1/2, N=132; AUGMENT-101 (NCT04065399); Sponsor: Syndax Pharmaceuticals; “Pipeline updates: (i) Entinostat: E2112 trial passed final interim OS analysis; trial continues, with final OS analysis expected in 2Q20; (ii) SNDX-5613: The Company expects to report initial clinical data from the…phase 1/2 open-label AUGMENT-101 trial…in 2020.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC at year end 2020 (Jones Trading) – Nov 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 68239157; Page no: 1; REPORT TITLE: “Infinity Pharmaceuticals, Inc.-3Q19 — Reiterating BUY & $3.50 PT. Mature phase 1b data potentially in mid/3Q20 likely to provide mechanistic insight; Phase 2 MARIO-3 data at YE20-10/31/2019 “; AUTHOR: Roy, Soumit, et al; DATE: 10/31/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) – Nov 5, 2019 – P1/2; N=220; Not yet recruiting; Sponsor: Dragonfly Therapeutics

 

Verzenio (abemaciclib) / Eli Lilly
COFEPRIS clears Eli Lilly’s onco drug Verzenio for Mexico market (GBI Health) – Nov 4, 2019 – “Eli Lilly last week announced the receipt of a marketing approval from Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) for its anti-cancer treatment Verzenio (abemaciclib). The oral drug is indicated as part of a first- or second-line combination therapy against hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to Present Immune Pharmacodynamic Data (IPD) Showing Immune Activation in Phase 2 Melanoma and Triple Negative Breast Cancer Study (GlobeNewswire, Biothera Pharmaceuticals, Inc.) – Nov 8, 2019 – P2, N=164; NCT02981303; Sponsor: Biothera; “In three previous mTNBC studies, CPI monotherapies resulted in a disease control rate of 7-10% (CR +PR+ SD >24 weeks), median overall survival (mOS) of 7-9 months and a 12-month OS of 37-40%. Primary data from the 44-patient Phase 2 study evaluating Imprime PGG and KEYTRUDA show a disease control rate of 25% (N= 11; 1 CR, 6 PR and 4 SD>24 weeks), mOS of 16.4 months and 12-month OS rate of 57.6%….Similar results were observed in the melanoma arm of the study, which tested the combination of Imprime PGG and KEYTRUDA in heavily CPI pre-treated melanoma patients (20 patients; 13/20 had ³2 prior CPI regimens and 17/20 had progressed on pembrolizumab). The disease control rate was 50% (1 CR and 9 SD as best response), 12-month OS rate was 45%.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Kisqali (ribociclib) / Novartis; veliparib (ABT-888) / AbbVie; Verzenio (abemaciclib) / Eli Lilly; Keytruda (pembrolizumab) / Merck (MSD); Zejula (niraparib) / GSK, J&J, Takeda
2019 Post European Society for Medical Oncology (ESMO) Report: Highlights from ESMO 2019 Congress – ResearchAndMarkets.com (Businesswire) – Nov 4, 2019 – “Conference highlights included new data from PARP inhibitors in ovarian cancer, such as Zejula, Lynparza and veliparib, as well as a follow-up update for KRAS-targeted drug AMG 510 for colorectal cancer, and CDK4/6-inhibitors, Kisqali and Verzenio, for breast cancer. Key pipeline updates for more established drugs were highly featured including Keytruda for non-small lung cancer and Kisqali for breast cancer.”

 

Nerlynx (neratinib) / Puma
CANbridge receives Hong Kong Department of Health market approval for Nerlynx (Businesswire) – Nov 5, 2019 – “CANbridge Pharmaceuticals Inc….announced that it received market approval from the Department of Health in Hong Kong for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early‑stage hormone receptor positive HER2-overexpressed/amplified breast cancer, and who completed adjuvant trastuzumab-based therapy less than one year ago.”

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Weekly Top News – IBD – November 11, 2019

November 11, 2019

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Initiation of P2/3 trial for Crohn’s disease in H1 2020 (Bausch Health) – Nov 5, 2019 – Q3 2019 Results 
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amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Amiselimod: Initiation of P2 trial for ulcerative colitis in H1 2020 (Bausch Health) – Nov 5, 2019 – Q3 2019 Reuslts 
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PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics announces first patient dosed in a phase 2 study of oral IL-23 receptor antagonist PTG-200 (JNJ-67864238) in the treatment of Crohn’s disease (PRNewswire) – Nov 6, 2019 – P2, N=90; PRISM (NCT04102111); Sponsor: Janssen Research & Development, LLC; “Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first patient has been dosed in a Phase 2 study of PTG-200 (also referenced as JNJ-67864238) in patients with moderate to severe Crohn’s disease…The global, randomized, double blind, placebo-controlled, Phase 2 study is evaluating the efficacy of oral administration of PTG-200 in 90 patients with moderate to severe Crohn’s disease…Clinical efficacy results for the Janssen Collaboration Asset are expected in 2021.”

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $5.9B peak for rheumatoid arthritis, $2.6B for ankylosing spondylitis, $1.1B for ulcerative colitis, $870M for psoriatic arthritis and $790M in Crohn’s disease by 2030 (Morgan Stanley) – Nov 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68200745; Page no: 3; REPORT TITLE: “Galapagos NV: MOR106 Stopped for futility.”; AUTHOR: Harrison, Matthew, et al; DATE: 10/28/2019

 

etrolizumab (RG7413) / Roche
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2) (clinicaltrials.gov) – Nov 10, 2019 – P3; N=350; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Dec 2020 –> Jul 2020; Trial primary completion date: Oct 2020 –> Mar 2020

 

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

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $3.1B in FY2019 (Cowen & Co) – Nov 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68241376; Page no: 19; REPORT TITLE: “Takeda Pharaceutical Co Ltd- Initiating coverage: Initiation: management is executing but pressures on key franchises outweigh”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/01/2019

 

Rinvoq (upadacitinib) / AbbVie
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy (clinicaltrials.gov) – Nov 4, 2019 – P3; N=645; Recruiting; Sponsor: AbbVie; Trial completion date: Feb 2021 –> Jun 2021; Trial primary completion date: Feb 2021 –> Jun 2021

 

Xeljanz (tofacitinib) / Pfizer
Health puts restrictions on Xeljanz (Pfizer) for risk of thromboembolism [Google Translation] (Redacción Médica) – Nov 6, 2019 – “The Agency for Medicines and Health Products ( Aemps ) has announced new restrictions on the use of Xeljanz, Pfizer medication with tofacitinib as an active ingredient that is indicated for various inflammatory diseases such as arthritis. This decision of the Aemps is motivated after the review carried out by the Committee for Risk Assessment in European Pharmacovigilance (PRAC ) on this drug.”

 

READ-UC: Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal (clinicaltrials.gov) – Nov 7, 2019 – P; N=310; Not yet recruiting; Sponsor: Pfizer

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Weekly Top News – Psoriasis – November 11, 2019

November 11, 2019

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

 

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

 

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

 

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

 

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

 

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

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Nov 8, 2019 – P3; N=108; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting

 

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

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Weekly Top News – Breast Cancer – November 4, 2019

November 4, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 regulatory estimate: Approval in Japan for breast cancer around Jan-Mar 2020 (Morgan Stanley) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68106862; Page no: 1; REPORT TITLE: “Pharmaceuticals: Japan week feedback: Daiichi Sankyo dominated discussion”; AUTHOR: Muraoka, Shinichiro, et al; DATE: 10/15/2019

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: PDUFA action date for HER2 positive metastatic breast cancer on April 29, 2020 (Daiichi Sankyo) – Nov 1, 2019 – Q2 FY 2019 Results 
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Kisqali (ribociclib) / Novartis
Novartis’ breast cancer treatment wins regulator’s nod (Korea Biomedical Review) – Oct 31, 2019 – “Novartis Korea said that the Ministry of Food and Drug Safety has approved Kisqali, a kinase inhibitor, for the treatment of women with advanced or metastatic breast cancer…The ministry approved the drug based on clinical findings demonstrating clinical efficacy, such as the significant prolonged survival rate of Kisqali.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at SABCS (December 11, 2019) (Daiichi Sankyo) – Nov 1, 2019 – Q2 FY 2019 Results 
[Screenshot]

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics reports third quarter 2019 results and provides corporate update (Immunomedics Press Release) – Oct 30, 2019 – “TROPHY-U-01 reached target enrollment in cisplatin-eligible cohort of 100 patients…’we are on target to submit our Biologics License Application (BLA) for sacituzumab govitecan in late-stage metastatic triple-negative breast cancer (mTNBC) in patients who have received at least two prior therapies for metastatic disease to the FDA in late November or early December, 2019’…In the open-label, Trop-2-enriched multi-cohort Phase 2 TROPiCS-03 study (NCT03964727), the first patient with NSCLC has been dosed.”

 

capecitabine / Generic Mfg.
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer (clinicaltrials.gov) – Oct 28, 2019 – P3; N=1384; Completed; Sponsor: Spanish Breast Cancer Research Group; Active, not recruiting –> Completed; Trial completion date: Jan 2019 –> Apr 2019

 

eftilagimod alpha (IMP 321) / Immutep; Keytruda (pembrolizumab) / Merck (MSD)
Operational update (GlobeNewswire) – Oct 28, 2019 – “Significant eftilagimod alpha clinical data expected in coming months: AIPAC Phase II – data expected in Q1 calendar year 2020; TACTI-002 Phase II – data at SITC in Nov 2019 and in Q1 in 2020; TACTI-mel Phase I – final safety data expected in H1 2020; INSIGHT-004 Phase I – initial safety data expected in Q4 calendar year 2019.”

 

Zirabev (bevacizumab biosimilar) / Pfizer; Trazimera (trastuzumab biosimilar) / Pfizer
Pfizer announces launch dates for 2 more anticancer biosimilars: Ruxience and Trazimera (Center for Biosimilars) – Oct 29, 2019 – “…Ruxience will become commercially available in January 2020, and Trazimera will follow on February 15, 2020. The company previously confirmed that it plans to launch its biosimilar bevacizumab, Zirabev, on December 31, 2019.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
AstraZeneca wins expanded indication for anticancer treatment Lynparza (Korea Biomedical Review) – Oct 30, 2019 – “AstraZeneca said that it has received approval from the Ministry of Food and Drug Safety for an additional indication for a new tablet formulation of Lynparza, its poly ADP (adenosine diphosphate)-ribose polymerase (PARP) inhibitor, in treating ovarian and breast cancer. Until now, the Lynparza capsule was the only approved formulation in Korea.”

 

Ibrance (palbociclib) / Pfizer; Herceptin (trastuzumab) / Roche
PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (clinicaltrials.gov) – Oct 31, 2019 – P3; N=496; Recruiting; Sponsor: Alliance Foundation Trials, LLC.; Trial completion date: Aug 2024 –> Dec 2025; Trial primary completion date: Oct 2020 –> May 2021

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Weekly Top News – IBD – November 4, 2019

November 4, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib launch estimate: 2021 for ulcerative colitis and Crohn’s disease (Credit Suisse) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183641; Page no: 31; REPORT TITLE: “First edition – US Alert: Friday, October 25, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 10/25/2019

 

Xeljanz (tofacitinib) / Pfizer
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019 (EMEA) – Oct 31, 2019 – “The PRAC concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. The PRAC recommended that Xeljanz should be used with caution in patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk…Patients older than 65 years of age should be treated with Xeljanz only when there is no other appropriate treatment.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib US sales projection: $35M in 2021, $80M in 2022, $165M in 2023 and $300M in 2024 to Gilead (Cowen & Co) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68178826; Page no: 4; REPORT TITLE: “Gilead Sciences Inc – Q3 In-line, guidance narrowed; Boring is ok, though it won’t drive a re-rating”; AUTHOR: Nadeau, Phil, et al; DATE: 10/24/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan patent expiry: 2024/2025 related to composition-of-matter (Cowen & Co) – Nov 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183642; Page no: 30; REPORT TITLE: “Bausch Health Companies Inc – Initiating Coverage Initiation: Transformed & diversified, Bausch Health should slowly grind higher”; AUTHOR: Cacciatore, Ken, et al; DATE: 10/25/2019

 

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

 

etrolizumab (RG7413) / Roche
Open-Label Extension and Safety Study for Patients With Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (clinicaltrials.gov) – Oct 31, 2019 – P3; N=900; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Apr 2024 –> Oct 2025; Trial primary completion date: Apr 2024 –> Oct 2025

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma to present new phase 3 data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting (GlobeNewswire) – Oct 28, 2019 – “RedHill Biopharma Ltd…announced that two oral presentations and two posters on two of the Company’s leading drug candidates, RHB-1051 (Talicia®, H. pylori infection) and RHB-104 (Crohn’s disease) will be presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting, being held October 25-30, in San Antonio, Texas.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan US patent expiry: July 2029 (Cowen & Co) – Nov 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68183642; Page no: 31; REPORT TITLE: “Bausch Health Companies Inc – Initiating Coverage Initiation: Transformed & diversified, Bausch Health should slowly grind higher”; AUTHOR: Cacciatore, Ken, et al; DATE: 10/25/2019

 

Rinvoq (upadacitinib) / AbbVie
A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies (clinicaltrials.gov) – Oct 30, 2019 – P3; N=501; Recruiting; Sponsor: AbbVie; Trial completion date: Mar 2022 –> Sep 2021; Trial primary completion date: Mar 2022 –> Sep 2021

 

Entyvio SC (vedolizumab SC) / Takeda
Douglas Wolf, MD: Vedolizumab subcutaneous treatment for ulcerative colitis (MD Magazine) – Nov 3, 2019 – “The biological license application to the FDA has already been submitted and things are in the works for approval of subcutaneous ENTYVIO. That approval is anticipated in in 2020. It may be early in 2020, it may be in the middle of 2020, it’s not absolutely unknown.”

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Weekly Top News – Psoriasis – November 4, 2019

November 4, 2019

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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