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The Digest

Pharma news roundup and Larvol updates

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Month: October 2019

Weekly Top News – Breast Cancer – October 14, 2019

October 14, 2019

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax’s entinostat advances in late-stage breast cancer study (SeekingAlpha) – Oct 7, 2019 – “Syndax Pharmaceuticals…announces the fifth and final successful interim futility analysis of survival data in the Cancer Research Group-sponsored Phase 3 clinical trial, E2112, evaluating the combination of lead drug entinostat and exemestane (Pfizer’s Aromasin) in patients with advanced HR+/HER2- breast cancer. The study will continue until 410 of the 608 participants have died, currently expected to occur in Q2 2020. If all goes well, the company expects to file a U.S. marketing application in late 2020.”

 

Kisqali (ribociclib) / Novartis
Kisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
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Piqray (alpelisib) / Novartis
Piqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
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Tecentriq (atezolizumab) / Roche
Roche’s atezolizumab is first breast cancer immunotherapy in Argentina (GBI Health) – Oct 12, 2019 – “Switzerland-based Roche has obtained an indication extension approval from Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) for its immuno-oncology product Tecentriq (atezolizumab) in combination with nab-paclitaxel or paclitaxel to treat triple negative breast cancer. The monoclonal antibody (mAb) was originally indicated against urothelial carcinoma (UC) and metastatic non-small cell lung cancer (NSCLC).”

 

triptorelin / Generic Mfg.; Xtandi (enzalutamide) / Pfizer, Astellas; pertuzumab/trastuzumab (RG6264) / Roche; Keytruda (pembrolizumab) / Merck (MSD)
SMC accepts lymphoma, lung cancer treatments in latest meeting (PharmaTimes) – Oct 8, 2019 – “In the latest Scottish Medicines Consortium (SMC) meeting, the committee has recommended four new medicines and rejected two…Among the positive opinions are Kite pharma’s Yescarta (axicabtagene ciloleucel), MSD’s cancer blockbuster Keytruda (pembrolizumab), Decapeptyl SR (triptorelin acetate)…Keytruda was approved for metastatic non-squamous non-small cell lung cancer (NSCLC), also through the PACE process…The committee also accepted Decapeptyl for the treatment of early stage breast cancer….On top of the four acceptances, the committee rejected Perjeta (pertuzumab) and Xtandi (enzalutamide) for the treatment of early stage breast cancer and prostate cancer, respectively.”

 

Zejula (niraparib) / GSK, J&J, Takeda
Clovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) – Oct 14, 2019 – “NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: CHF3,683M in 2023 (Deutsche Bank Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68025177; Page no: 2; REPORT TITLE: “Roche Holding ltd- Roche: ESMO feedback: IMpowering the Tecentriq brand”; AUTHOR: Parkes, Richard, et al; DATE: 09/30/2019

 

AVID100 / Formation Biologics
Forbius: phase 2 clinical data with tumor-selective anti-EGFR ADC AVID100 featured at AACR-NCI-EORTC and World ADC San Diego (Businesswire) – Oct 10, 2019 – “Forbius…will today present the first clinical data from its Phase 2 development program with novel, tumor-selective anti-EGFR ADC AVID100 at the 10th Annual World ADC in San Diego (Oct. 8 – 11). AVID100 clinical data will also be featured in an upcoming poster presentation at the AACR-NCI-EORTC meeting in Boston (Oct. 26 – 30).”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab sales projection: $300-400M peak for 3L HER2+ breast cancer setting (Cowen & Co) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67965816; Page no: 2377; REPORT TITLE: “Biotechnology quarterly”; AUTHOR: Cowen Biotechnology Team, et al; DATE: 09/16/2019

 

Ibrance (palbociclib) / Pfizer
Ibrance sales projection: $8.7B in 2023 (Infinata) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 1; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

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Weekly Top News – IBD – October 14, 2019

October 14, 2019

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Data from P3 TRUE NORTH trial (NCT02435992) for moderate-to-severe ulcerative colitis in mid-2020 (Guggenheim) – Oct 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68001013; Page no: 2; REPORT TITLE: “Highlights from our autoImmune/immunology KOL series Part 3: Emerging treatment landscape in Crohn’s Disease and ulcerative colitis”; AUTHOR: Fernandez, Seamus, et al; DATE: 09/24/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Topline data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H1 2020 (Cantor Fitzgerald) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016498; Page no: 1; REPORT TITLE: “Cantor conference class of 2019: Top questions, catalysts, and who is most likely to….”; AUTHOR: Research Department; DATE: 09/26/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma Announces Full Results from Positive MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Open-Label Extension Study with RHB-104 in Crohn’s Disease (GlobeNewswire, RedHill Biopharma Ltd.) – Oct 11, 2019 – P3, N=330; MAPUS (NCT01951326); P3, N=331; MAPUS2 (NCT03009396); Sponsor: NCT01951326; “RedHill Biopharma Ltd…announced full Week 52 results for all subjects in the previously announced positive Phase 3 randomized, controlled study of RHB-104 in Crohn’s disease (the ‘MAP US study’) and supportive top-line results from the open-label extension Phase 3 study (the ‘MAP US2 study’). The full Week 52 results of blinded treatment in the MAP US Phase 3 study….continued to meet its primary endpoint…”

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz US sales projection: $2.7B in 2024 (Infinata) – Oct 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 14; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

 

Humira (adalimumab) / Eisai, AbbVie; Remicade (infliximab) / Mitsubishi Tanabe, J&J
HLA-DQA1*05 carriage associated with development of anti-drug antibodies to infliximab and adalimumab in patients with Crohn’s disease (Gastroenterology) – Oct 7, 2019 – P=NA, N=1,240; “We performed a genome-wide association study to identify variants associated with time to development of anti-drug antibodies in…patients with Crohn’s disease starting infliximab or adalimumab therapy…In an observational study, we found a genome-wide significant association between HLA-DQA1*05 and the development of antibodies against anti-TNF agents.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $4B in 2027 (Oppenheimer) – Oct 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68004961; Page no: 1; REPORT TITLE: “Amgen Inc- Key takeaways from meeting with management”; AUTHOR: Research Department; DATE: 09/24/2019

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Weekly Top News – Psoriasis – October 14, 2019

October 14, 2019

Stelara (ustekinumab) / J&J
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of pediatric patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 7, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO)….The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma presents long-term study results that show significant skin clearance with Ilumya (tildrakizumab-asmn) maintained over four years in people with moderate-to-severe plaque psoriasis (PRNewswire) – Oct 9, 2019 – P3, N=772; reSURFACE 1 (NCT01722331); Sponsor: Sun Pharma; P3, N=1,090; reSURFACE 2 (NCT01729754); Sponsor: Sun Pharma; “Sun Pharmaceutical Industries…today announced that one of its wholly owned subsidiaries presented long-term follow-up data from ILUMYA

® (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.”

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 (Eli Lilly Press Release) – Oct 12, 2019 – P3, N=201; Ixora-peds (NCT03073200); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today 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, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area…Results of the study are being 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.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NHS Scotland accepts AbbVie’s Skyrizi (risankizumab) (Pharmafield) – Oct 8, 2019 – “NHS Scotland accepts AbbVie’s SKYRIZI (risankizumab) in a positive Detailed Advice Document published by the Scottish Medicine Consortium….It confirms that SKYRIZI (risankizumab) is recommended for the treatment of moderate to severe psoriasis in adult patients”

 

Cosentyx (secukinumab) / Novartis
Novartis real-world evidence confirms high efficacy, long-term response and favorable safety profile of Cosentyx in clinical practice (Novartis Press Release) – Oct 9, 2019 – “These extensive results confirm what has been previously observed in Phase 3 clinical trials, and support our continued use of Cosentyx in psoriatic disease…Real-world evidence and observational studies help to bridge the gap in knowledge that exists between clinical trials and clinical practice….These data are being presented at the 28th Congress of the European Academy of Dermatology and Venereology (EADV), 9-13 October 2019, Madrid, Spain.”

 

bimekizumab (UCB4940) / UCB; Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
UCB showcases wealth of new psoriasis research at EADV 2019 (UCB Press Release) – Oct 9, 2019 – “UCB…today announced new data on…CIMZIA® (certolizumab pegol), in psoriasis and psoriatic arthritis (PsA) will be presented at the 28th European Academy of Dermatology and Venereology congress (EADV) in Madrid, October 9-13, 2019….New 60-week data on novel investigational molecule bimekizumab, from the BE ABLE Phase 2 clinical development program, will be shared in an oral presentation.”

 

Stelara (ustekinumab) / J&J; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LEO Pharma to highlight data at 28th Congress of the European Academy of Dermatology (EADV) (LEO Pharma Press Release) – Oct 9, 2019 – “LEO Pharma…today announced that data from company-sponsored, health economic outcome and investigator-initiated studies will be presented at the 28th annual Congress of the European Academy of Dermatology (EADV), Oct. 9-13, in Madrid, Spain.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Humira (adalimumab) / Eisai, AbbVie
AbbVie announces new data from its dermatology portfolio and pipeline at the 28th European Academy of Dermatology and Venereology (EADV) congress (PRNewswire) – Oct 9, 2019 – “AbbVie…today announced that it will present new results evaluating the safety and efficacy of SKYRIZI™ (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as…upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid….In addition, Phase 2b results evaluating time to treatment response with upadacitinib…under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation.”

 

Taltz (ixekizumab) / Eli Lilly; mirikizumab (LY3074828) / Eli Lilly
Lilly to unveil new data for the treatments of complex dermatological conditions at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (PRNewswire) – Oct 8, 2019 – “Eli Lilly and Company…announced today that it will present new data for Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab at the 28th annual European Academy of Dermatology and Venereology (EADV) Congress taking place Oct. 9-13 in Madrid, Spain…Lilly will present findings from a Phase 3 trial of Taltz for pediatric patients with moderate to severe psoriasis….Posters to be shared around Lilly’s investigational compound, mirikizumab, include research from a study measuring patient outcomes and health-related elements of quality of life for individuals with moderate to severe psoriasis.”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

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Weekly Top News – Breast Cancer – October 7, 2019

October 7, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Safety data consistent with known safety profile of Verzenio”; Metastatic breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
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Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in mid-2021 (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
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Verzenio (abemaciclib) / Eli Lilly
Health-related quality of life in MONARCH 3: Abemaciclib plus an aromatase inhibitor as initial therapy in women with HR-positive (HR +), HER2-negative (HER2) advanced breast cancer (DGHO 2019) – Sep 30, 2019 – Abstract #P1006; Pres time: Oct 14, 2019; 12:00 PM – 12:05 PM; Location: A6; P3; “Abemaciclib plus AI resulted in clinically meaningful and statistically significant changes in diarrhea, and clinically not meaningful differences in other symptom scores. Increased GI-related symptoms were consistent with the manageable, reversible AE profile. No clinically meaningful differences in global health status or functional scores were observed.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Abemaciclib + NSAI and Abemaciclib + fulvestrant showed significant PFS benefit in predominantly Chinese HR +/HER –advanced breast cancer patients”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019
P3 data
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Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Verzenio significantly extended life by 9.4 months”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Tecentriq (atezolizumab) / Roche
Tecentriq by Roche not approved on NHS for triple negative breast cancer (Pharmafield) – Oct 3, 2019 – “Draft guidance published by NICE does not recommend atezolizumab, Tecentriq by Roche, for treating people with a type of breast cancer that has spread to other parts of the body….Atezolizumab with nab-paclitaxel does not meet NICE’s Cancer Drugs Fund criteria because it does not have a plausible potential to be cost-effective and there is no clear evidence that further trial data would resolve the uncertainties associated with this appraisal.”

 

Ibrance (palbociclib) / Pfizer; Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
CDK4/6 inhibitor+fulvestrant combo nears getting benefit (Korea Biomedical Review) – Oct 2, 2019 – “The combination therapy of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and fulvestrant for advanced or metastatic breast cancer has taken the first step to receive insurance benefits. The Health Insurance Review and Assessment Service (HIRA)’s Cancer Drug Review Committee decided in September to grant reimbursement for Pfizer’s Ibrance (ingredient: palbociclib) plus fulvestrant and Lilly’s Verzenio (abemaciclib) plus fulvestrant, sources said on Monday.”

 

Tecentriq (atezolizumab) / Roche
A small molecule triple-negative breast cancer immunotherapy that targets the Liver-X-Receptor. (CRI-CIMT-EATI-AACR 2019) – Oct 4, 2019 – Abstract #A203; “There is only FDA-approved immunotherapy for TNBC, Atezolizumab for patients with high PD-L1 expression, which unfortunately only marginally improves patient survival (~2 months)…Lastly, through extracellular flux analysis and mitochondrial activity profiling we have determined that LXR activation severely disrupts mitochondrial function in CD8+ T-cells. Our discoveries implicate LXR as a central mediator of TNBC immune evasion and as a promising treatment target for the development of novel small molecule immunotherapies for TNBC.”

 

 

Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
Abemaciclib in combination with fulvestrant in patients with HR + / HER2- advanced breast cancer who had demonstrated primary or secondary resistance to previous endocrine therapy (DGHO 2019) – Sep 30, 2019 – Abstract #P1008; Pres time: Oct 14, 2019; 12:10 PM – 12:15 PM; Location: A6; P3; “Abemaciclib+F improved PFS and ORR with a generally tolerable safety profile in pts with HR+/HER2- ABC and primary/secondary ETR. Although pts with primary ETR typically have poor prognosis, the benefit from abemaciclib+F was maintained in this population. Previously presented at ESMO 2018, FPN 329P, Grischke E et al.”

 

Verzenio (abemaciclib) / Eli Lilly
Management of abemaciclib-associated adverse events in patients with HR + / HER2- advanced breast cancer: analysis of MONARCH studies (DGHO 2019) – Sep 30, 2019 – Abstract #P1007; Pres time: Oct 14, 2019; 12:05 PM – 12:10 PM; Location: A6; P2, P3; “Introduction: Abemaciclib is a CDK4/6 inhibitor dosed continuously, with demonstrated efficacy and an acceptable safety profile in patients (pts) with HR+/HER2- advanced breast cancer (ABC) alone (MONARCH 1, NCT02102490) or in combination with fulvestrant (MONARCH 2, NCT02107703) or non-steroidal aromatase inhibitors (MONARCH 3, NCT02246621). Abemaciclib dose adjustments and/or supportive medication were effective in managing AEs in pts with ABC in the MONARCH trials. Understanding the safety profile of abemaciclib can inform AE management and can extend time on treatment. Previously presented at ESMO 2018, FPN 339P, Rugo HS et al.”

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Weekly Top News – IBD – October 7, 2019

October 7, 2019

Stelara (ustekinumab) / J&J
REAL WORLD EXPERIENCE WITH USTEKINUMAB IN PAEDIATRIC CROHN´S DISEASE. A MULTICENTRE RETROSPECTIVE STUDY FROM PAEDIATRIC IBD PORTO GROUP OF ESPGHAN (UEGW 2019) – Oct 4, 2019 – Abstract #LB05; Pres time: Oct 21, 2019; 02:48 PM – 03:00 PM; Location: F3; “This abstract will be published on October 21, 2019”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi launch estimate: 2022 for Crohn’s disease and 2023 for ulcerative colitis (UBS) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68017232; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Gastroenterology – Takeaways from UBS expert symposium””; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

 

Humira (adalimumab) / Eisai, AbbVie
An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial (clinicaltrialsregister.eu) – Oct 5, 2019 – P4; N=238; Ongoing; Sponsor: GETAID

 

Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer; Remsima SC (infliximab biosimilar SC) / Celltrion
NONINFERIORITY OF NOVEL SUBCUTANEOUS INFLIXIMAB (CT-P13) TO INTRAVENOUS INFLIXIMAB (CT-P13) IN PATIENTS WITH ACTIVE CROHN’S DISEASE AND ULCERATIVE COLITIS: WEEK 30 RESULTS FROM A MULTICENTRE, RANDOMISED CONTROLLED PIVOTAL TRIAL (UEGW 2019) – Oct 4, 2019 – Abstract #LB02; Pres time: Oct 21, 2019; 02:12 PM – 02:24 PM; Location: F3; “This abstract will be published on October 21, 2019”

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $4.3B by 2022 (Deutsche Bank Research) – Oct 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67968779; Page no: 2; REPORT TITLE: “Roche: Pharma day; biosimilar headwinds should soon be in the rear view”; AUTHOR: Parkes, Richard, et al; DATE: 09/17/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq sales projection: $5.6B peak (UBS) – Oct 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016563; Page no: 1; REPORT TITLE: “US Pharmaceuticals “UBS healthcare expert symposium: Dermatology panel key …”; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

 

etrolizumab (RG7413) / Roche
Etrolizumab sales projection: CHF765M in 2025 (Deutsche Bank Research) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67968779; Page no: 2; REPORT TITLE: “Roche Holding Ltd- Roche: Pharma Day; Biosimilar headwinds should soon be in the rear view”; AUTHOR: Parkes, Richard, et al; DATE: 09/17/2019
Sales projection

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9B in 2019 and $2.2B in 2020 (Cowen & Co) – Sep 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2914; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

BMS-986165 / BMS
BMS-986165 sales projection: Consensus of $3.5B peak (Exane BNP Paribas) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67972680; Page no: 38; REPORT TITLE: “Pharmaceuticals: Champions League 2019: Powered by pulse “; AUTHOR: Hector, Luisa, et al; DATE: 09/17/2019

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz sales projection: $1B peak for gastrointestinal disorders (UBS) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68017232; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Gastroenterology – Takeaways from UBS expert symposium””; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

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Weekly Top News – Psoriasis – October 7, 2019

October 7, 2019

Stelara (ustekinumab) / J&J
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of pediatric patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 7, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO)….The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study…”

Tremfya (guselkumab) / J&J; Taltz (ixekizumab) / Eli Lilly
New head-to-head data show Taltz (ixekizumab) superiority versus Tremfya (guselkumab) in people with moderate to severe plaque psoriasis (PRNewswire) – Oct 3, 2019 – P4, N=1,027; IXORA-R (NCT03573323); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…today presented detailed data at the 5th Annual Maui Derm NP+PA Fall meeting from the Phase 4 IXORA-R study, the first head-to-head (H2H) study…using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint. Taltz met the primary endpoint of superiority vs. TREMFYA in the proportion of patients with moderate to severe plaque psoriasis achieving complete skin clearance…as well as key secondary endpoints. The study is ongoing through Week 24….Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020.”

 

ANB019 / AnaptysBio
AnaptysBio reports positive topline data from interim analysis of GALLOP phase 2 clinical trial of ANB019 monotherapy in moderate to severe generalized pustular psoriasis (AnaptysBio Press Release) – Sep 30, 2019 – P2, N=10; GALLOP (NCT03619902); Sponsor: AnaptysBio, Inc; “AnaptysBio…today announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 in moderate-to-severe generalized pustular psoriasis (GPP) patients, also known as the GALLOP trial. Enrollment is ongoing and AnaptysBio anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020…ANB019 was generally well-tolerated and no serious or severe adverse events were reported in this interim analysis.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9B in 2019 and $2.2B in 2020 (Cowen & Co) – Sep 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67971845; Page no: 2914; REPORT TITLE: “Therapeutic categories outlook”; AUTHOR: Cowen Health Care Research, et al; DATE: 09/17/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales estimate: $81M (consensus: $65M) in Q3 2019; Skyrizi US sales projection: $243M (consensus: $205M) in FY2019 (UBS) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016563; Page no: 1; REPORT TITLE: “US Pharmaceuticals “UBS healthcare expert symposium: Dermatology panel key …””; AUTHOR: Jacob, Navin, et al; DATE: 09/26/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi revenue projection: Guidance of $150M in H2 2019 (Zacks) – Oct 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67978057; Page no: 5; REPORT TITLE: “AbbVie Inc.(ABBV) Zacks company report”; AUTHOR: Research Department; DATE: 09/18/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales estimate: $86M (consensus: $65M) in Q3 2019; Skyrizi US sales projection: $263M (consensus: $205M) in FY2019 (UBS) – Oct 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 68021393; Page no: 1; REPORT TITLE: “US Pharmaceuticals “New product launch tracker””; AUTHOR: Jacob, Navin, et al; DATE: 09/27/2019

 

BMS-986165 / BMS
BMS-986165 sales projection: Consensus of $3.5B peak (Exane BNP Paribas) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67972680; Page no: 38; REPORT TITLE: “Pharmaceuticals: Champions League 2019: Powered by pulse “; AUTHOR: Hector, Luisa, et al; DATE: 09/17/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $120M peak (Credit Suisse) – Oct 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 68021370; Page no: 4; REPORT TITLE: “India Pharma Sector – Quick take – Ilumya volume trend not encouraging; Aurobindo gained 47% share in Makena; Uloric exclusivity sees lower competition”; AUTHOR: Aggarwal, Anubhav, et al; DATE: 09/27/2019

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