The Digest

Pharma news roundup and Larvol updates

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Month: November 2019

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November 29, 2019

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Weekly Top News – Breast Cancer – November 25, 2019

November 25, 2019

margetuximab (MGAH 22) / MacroGenics
Margetuximab US regulatory estimate: Approval for HER2+ metastatic breast cancer in H1 2020 (Cowen & Co) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68286929; Page no: 2; REPORT TITLE: “Margetuximab BLA in 4Q19; Flotetuzumab data in AML at ASH 2019”; AUTHOR: Peaker, Boris, et al; DATE: 11/06/2019

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab launch estimate: 2020 for breast cancer and 2022 for gastric cancer (BTIG) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68154141; Page no: 2; REPORT TITLE: “MacroGenics, Inc. – More mature data from SOPHIA looking cleaner with 158F OS HR=0.79”; AUTHOR: Shrader, Thomas, et al; DATE: 10/23/2019

 

GDC-9545 / Roche; Herceptin (trastuzumab) / Roche; ipatasertib (GDC-0068) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Perjeta (pertuzumab) / Roche
Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium (Businesswire) – Nov 18, 2019 – “Genentech…announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019…New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta® (pertuzumab) and Herceptin® (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC)…Genentech will also present data from the primary analysis of the Phase III FeDeriCa study…”

 

Piqray (alpelisib) / Novartis
Alpelisib: “The Committee was reminded of the status of this application and its remaining outstanding issues [treatment of HR-positive/HER2-negative, advanced breast cancer in combination with fulvestrant]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of outstanding issues with a specific timetable.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca; Kadcyla (ado-trastuzumab emtansine) / Roche; U3-1402 / Daiichi Sankyo
Positive pivotal data for Daiichi Sankyo’s DS-8201 ([fam]-trastuzumab deruxtecan) in patients with HER2 positive metastatic breast cancer to be presented at SABCS (Businesswire) – Nov 19, 2019 – “Positive data from the pivotal phase 2 DESTINY-Breast01 trial of DS-8201 ([fam-] trastuzumab deruxtecan), an investigational HER2 targeting antibody drug conjugate (ADC), will be unveiled….Trial-in-progress updates from the pivotal phase 3 development program of DS-8201 in patients with HER2 positive metastatic breast cancer, including a head-to-head study with ado-trastuzumab emtansine, and in patients with HER2 low metastatic breast cancer, also will be presented. An overview of the phase 1/2 trial for U3-1402, an investigational HER3 targeting ADC, in HER3 expressing advanced/unresectable or metastatic breast cancer also will be featured at SABCS.”

 

Tecentriq (atezolizumab) / Roche; Kisqali (ribociclib) / Novartis; Lenvima (lenvatinib) / Eisai, Merck (MSD)
Breast and kidney cancer drugs approved on NHS Scotland (Medical Xpress) – Nov 22, 2019 – “Lenvatinib has been accepted for use in combination with another targeted drug called everolimus (Afinitor), which stops cancer growing by starving it of blood…Access to the targeted treatment ribociclib has also been approved for some women with breast cancer in Scotland whose cancer has spread near to where their tumor first appeared, or to another part of the body….Based on the clinical trial evidence presented by atezolizumab’s manufacturer, the SMC decided the treatment did not offer enough value to patients for the drug combination to be cost effective.”

 

sacituzumab govitecan (IMMU-132) / Immunomedics
IMMU-132 clinical trial estimate: Data from P3 ASCENT trial (NCT02574455) for TNBC in mid-2020 (Zacks) – Nov 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68305709; Page no: 3; REPORT TITLE: “Immunomedics, Inc.(IMMU) Zacks company report”; AUTHOR: Research Department; DATE: 11/08/2019

 

tremelimumab (CP-675206) / AstraZeneca, Pfizer; Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
GUIDE2REPAIR: Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment (clinicaltrials.gov) – Nov 20, 2019 – P2; N=270; Not yet recruiting; Sponsor: Centre Georges Francois Leclerc

 

Ibrance (palbociclib) / Pfizer
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (clinicaltrials.gov) – Nov 25, 2019 – P; N=1; Active, not recruiting; Sponsor: Pfizer

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Kadcyla: “The Committee discussed the issues identified in this application, mainly relating to the wording of the indication in relation to the studied population and the request for 1 year of market protection [extension of indication to include the adjuvant treatment of adult patients with HER2-positive early breast cancer]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The Committee adopted a 2nd request for supplementary information with a specific timetable.”

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Weekly Top News – IBD – November 25, 2019

November 25, 2019

Humira (adalimumab) / Eisai, AbbVie
Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Nov 22, 2019 – P3; N=952; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan clinical trial estimate: Interim data from P2 trial (NCT03515044) for overt hepatic encephalopathy in Q4 2019 (Cowen & Co) – Nov 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 68320235; Page no: 2; REPORT TITLE: “Bausch Health Companies Inc- Model update: Thesis unchanged – Reiterate (1)”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/11/2019

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Data from P2 trial for Crohn’s disease in H1 2021 (Stifel 2019 Healthcare Conference, Protagonist Therapeutics) – Nov 21, 2019 
[Screenshot]

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The Committee discussed the issues identified in this application, mainly concerning the clinical efficacy data and the feasibility of a registry analyses [extension application to introduce a new pharmaceutical form (prolonged-release tablet) associated with a new strength (11 mg)]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The Committee adopted the CHMP recommendation and scientific discussion together with a 3rd list of outstanding issues and a specific timetable.”

 

etrasimod (APD334) / Arena
CULTIVATE: A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Nov 21, 2019 – P2b; N=225; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

filgotinib (GLPG0634) / Gilead
Filgotinib pricing projection: $50,00/year (SunTrust) – Nov 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 68321433; Page no: 59; REPORT TITLE: “Gilead Sciences Inc.-Initiating coverage – Initiating at Hold and $70 PT; HIV deep-dive on patent cliffs & PrEP”; AUTHOR: Research Department; DATE: 11/11/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Doctor urges Alberta not to switch coverage to cheaper meds for patients with IBD (Yahoo News) – Nov 21, 2019 – “Alberta is looking to switch to covering a cheaper alternative medication for patients with inflammatory bowel disease (IBD) — a move an expert says could harm some patients’ health…The minister’s office said in the past decade, the province’s spending on biologics has increased from around $20 million per year to more than $200 million…But the maker of Remicade, one of the biologics for Crohn’s patients that would be impacted, said it has reached out to the government to offer its product at a cost comparable to biosimilars.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Patent delisted for Xifaxan from Orange Book (Orange Book) – Nov 20, 2019 – Patent no. 10314828 
[Screenshot]

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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 – Breast Cancer – November 18, 2019

November 18, 2019

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

 

Tecentriq (atezolizumab) / Roche; Kisqali (ribociclib) / Novartis; Lenvima (lenvatinib) / Eisai, Merck (MSD)
NHS Scotland adopts five new medicines (Holyrood Magazine) – Nov 11, 2019 – “Medicines to treat kidney and breast cancer are among five new treatments which have been accepted for use within NHS Scotland, by the Scottish Medicines Consortium (SMC). Ribociclib (Kisqali) for breast cancer treatment, lenvatinib (Kisplyx) for kidney cancer…were all accepted for use in the NHS after SMC committee members heard a range of evidence on the medications…However, the SMC also rejected an immunotherapy drug, known as atezolizumab. The medicine is used to treat patients with bladder of urinary cancer, or non-small cell lung cancer (NSCLC).”

 

GDC-9545 / Roche; Herceptin (trastuzumab) / Roche; ipatasertib (GDC-0068) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Perjeta (pertuzumab) / Roche
Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium (Businesswire) – Nov 18, 2019 – P3, N=500; FeDeriCa (NCT03493854); Sponsor: Hoffmann-La Roche; P3, N=4,804; APHINITY (NCT01358877); Sponsor: Hoffmann-La Roche; “Genentech…announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019…New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta® (pertuzumab) and Herceptin® (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC)….Genentech will also present data from the primary analysis of the Phase III FeDeriCa study…”

 

Keytruda (pembrolizumab) / Merck (MSD)
OncoSec presents immunological data associated with positive tumor response from Tavo KEYNOTE studies evaluating patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting (PRNewswire) – Nov 12, 2019 – P2, N=100; PISCES (NCT03132675); Sponsor: OncoSec Medical Incorporated; P2, N=25; KEYNOTE-890 (NCT03567720); Sponsor: OncoSec Medical Incorporated; “The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported….underscoring a predictable and consistently well-tolerated safety profile.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (GlobeNewswire) – Nov 15, 2019 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. Based on this recommendation, a final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future….The recommendation from the CHMP is based on results from the phase III KATHERINE study…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
AZ’s Lynparza is first PARP inhibitor to enter Cuba market (GBI Health) – Nov 15, 2019 – “According to GBI analysis, UK-based AstraZeneca last week obtained marketing approval from Cuba’s Center for State Control of Drugs and Medical Devices (CECMED) for its oncology therapy Lynparza (olaparib). The oral drug is used a treatment against breast cancer susceptibility gene (BRCA)-mutated ovarian and breast cancers. However, the agency does not publish indication details.”

Lenvima (lenvatinib) / Eisai, Merck (MSD); Halaven (eribulin mesylate) / Eisai
Biotoscana heralds upcoming arrival of Eisai’s Lenvima, Halaven to Argentina (GBI Health) – Nov 11, 2019 – “Biotoscana, a subsidiary of Canada’s Knight Therapeutics, last week announced plans to launch Eisai’s oncology drugs Halaven (eribulin mesylate) and Lenvima (lenvatinib) to the Argentina market in December 2019 or January 2020. The treatments were in-licensed by Biotoscana for Latin America ex-Mexico in 2017, as GBI reported…Halaven’s registration filing is as a breast cancer treatment, while Lenvima’s indications are against hepatic, kidney, and thyroid cancers.”

 

Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCell
BriaCell to present clinical findings at the 2019 San Antonio Breast Cancer Symposium December 12th and 13th (GlobeNewswire) – Nov 12, 2019 – P1/2, N=60; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “BriaCell Therapeutics Corp….is pleased to announce its lead product candidate, Bria-IMT™, will be featured in two poster sessions during the 2019 San Antonio Breast Cancer Symposium® (SABCS) taking place December 10-14 in San Antonio, Texas.”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly’s breast cancer therapy abemaciclib market filing accepted for review in China (GBI Health) – Nov 15, 2019 – “According to the Center for Drug Evaluation’s (CDE) website, US major Eli Lilly’s market filing for import of CDK4/6 inhibitor abemaciclib has been accepted for review. Abemaciclib is a cell-cycle inhibitor designed to block the growth of cancer cells by specifically inhibiting CDK4/6. Lilly initiated a multi-center Phase III clinical trial including China that enrolled 450 post-menopausal patients globally suffering from locally recurrent or metastatic breast cancer, with 360 of those to be in China, as GBI reported in 2016. The MONARCH plus Phase III clinical study was concluded ahead of schedule…”

Syros reports third quarter 2019 financial results and highlights key accomplishments and upcoming milestones (Syros Press Release) – Nov 12, 2019 – “Syros plans to complete enrollment in the newly diagnosed unfit AML cohorts of the ongoing Phase 2 trial in the fourth quarter of this year…Syros plans to report potential proof-of-concept data from the ongoing cohort evaluating SY-1425 in combination with azacitidine in RARA-positive patients with relapsed or refractory AML in 2020; Syros plans to complete investigational new drug application-enabling studies by year-end and initiate a Phase 1 trial of SY-5609 in the first quarter of 2020 in patients with select solid tumors, including breast, lung and ovarian cancers…”

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Weekly Top News – IBD – November 18, 2019

November 18, 2019

etrolizumab (RG7413) / Roche
Etrolizumab: Data from P3 COTTONWOOD trial (NCT02118584) for advanced ulcerative colitis in 2020 (Roche) – Nov 13, 2019 – ASN/ACR 2019 
[Screenshot]

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Launch in UK, Germany and Benelux for ulcerative colitis in 2021 (Galapagos) – Nov 15, 2019 – Annual R&D Update 
[Screenshot]

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan clinical trial estimate: Interim data from P2 trial (NCT03515044) for overt hepatic encephalopathy in Q4 2019 (Cowen & Co) – Nov 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 68320235; Page no: 2; REPORT TITLE: “Bausch Health Companies Inc- Model update: Thesis unchanged – Reiterate (1)”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/11/2019

 

Xeljanz (tofacitinib) / Pfizer
EMA cautions on Pfizer’s Xeljanz (SeekingAlpha) – Nov 15, 2019 – “Citing data from an ongoing study…the European Medicines Agency recommends that Pfizer’s…rheumatoid arthritis med Xeljanz (tofacitinib) be used with caution in all patients at high risk of blood clots. Combined results from multiple sources showed that the risk of blood clots in deep veins and lungs was higher in patients taking Xeljanz, especially the 10 mg twice-daily dose, and those being treated for an extended period.”

 

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

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Newly added patent in Orange Book (Orange Book) – Nov 14, 2019 – Expiry on February 26, 2029 
[Screenshot]

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $134M in Q4 2019 (Credit Suisse) – Nov 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 68256114; Page no: 10; REPORT TITLE: “Credit Suisse India daily: Top stories and ideas”; AUTHOR: Gupta, Ashish, et al; DATE: 11/04/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $250M in CY2019 and $2-3B 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

 

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $1.7B by 2023 (Credit Suisse) – Nov 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 68234984; Page no: 32; REPORT TITLE: “Last Edition – US: Thursday, October 31, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 10/31/2019

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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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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 
[Screenshot]

 

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 
[Screenshot]

 

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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