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Month: January 2020

Weekly Top News – Breast Cancer – January 27, 2020

January 27, 2020

Talzenna (talazoparib) / Pfizer
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (clinicaltrials.gov) – Jan 24, 2020 – P3; N=429; Recruiting; Sponsor: BioMarin Pharmaceutical

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Swiss Regulator grants additional approval for Roche’s antibody-drug Kadcyla (Reuters) – Jan 24, 2020 – “ROCHE’S KADCYLA APPROVED FOR A NEW INDICATION IN EARLY HER2-POSITIVE BREAST CANCER IN SWITZERLAND…ADDITIONAL APPROVAL OF KADCYLA IS BASED ON THE PHASE III KATHERINE STUDY, IN WHICH PATIENTS WITH AN EARLY FORM OF HER2-POSITIVE BREAST CANCER WHO WERE TREATED WITH KADCYLA HAD A 50% REDUCED RISK OF RELAPSE OR DEATH COMPARED TO STANDARD THERAPY.”

 

Tecentriq (atezolizumab) / Roche
IMpassion131: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov) – Jan 22, 2020 – P3; N=600; Recruiting; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Recruiting

 

Ibrance (palbociclib) / Pfizer
Ibrance pricing: Wholesale acquisition cost of $10,963/month (Cowen & Co) – Jan 24, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 646; REPORT TITLE: – “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

Kisqali (ribociclib) / Novartis
Kisqali pricing: $10,950/600mg for 28-days, $8,760/400mg dose and $4,380/200mg dose (Cowen & Co) – Jan 24, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 548; REPORT TITLE: – “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

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Weekly Top News – IBD – January 27, 2020

January 27, 2020

JNJ-64304500 / J&J
JNJ-64304500: NME filing in US for Crohn’s disease between 2020-2023 (J&J) – Jan 22, 2020 – Pipeline Update: Regulatory submission in EU for Crohn’s disease between 2020-2023 
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Tremfya (guselkumab) / J&J
Tremfya: Data from P2/3 GALAXI trial (NCT03466411) for Crohn’s disease in 2020 (J&J) – Jan 22, 2020 – Key 2020 Events 
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Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn’s Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 (clinicaltrials.gov) – Jan 21, 2020 – P3; N=1250; Recruiting; Sponsor: AbbVie; N=912 –> 1250

 

Stelara (ustekinumab) / J&J
NICE rejects Janssen’s Stelara on cost efficiency grounds (PharmaTimes) – Jan 22, 2020 – “The National Institute for Health and Care Excellence (NICE) has released a draft guidance not recommending Janssen’s Stelara (ustekinumab) for moderately to severely active ulcerative colitis in adults….NICE said that it already recommends several treatment options…The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment, but the company has agreed a confidential pricing arrangement for the drug with the Commercial Medicines Unit.”

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Remicade ex-US sales estimate: $400M in 2019; Remicade ex-US sales projection: $300M in 2020 and $5M in 2025 (Cowen & Co) – Jan 21, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 494; REPORT TITLE: – “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

PF-06480605 / Pfizer
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 23, 2020 – P2b; N=240; Recruiting; Sponsor: Pfizer; Not yet recruiting –> Recruiting

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz sales estimate: $2.275B in 2019; Xeljanz sales projection: $2.645B in 2020 and $4.405B in 2025 (Cowen & Co) – Jan 22, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 670; REPORT TITLE: – “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales estimate: $275M in 2019; Skyrizi sales projection: $850M in 2020 and $3.4B in 2025 (Cowen & Co) – Jan 21, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 72; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

Humira (adalimumab) / Eisai, AbbVie
Humira sales estimate: $19.125B in 2019; Humira sales projection: $18.955B (guidance: $21B) in 2020, $14B in 2023, $10B in 2024 and $5.5B in 2025 (Cowen & Co) – Jan 21, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 35, 52; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Simponi ex-US sales estimate: $835M in 2019; Simponi ex-US sales projection: $795M in 2020 and $550M in 2025 (Cowen & Co) – Jan 21, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 494; REPORT TITLE: – “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

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Weekly Top News – Psoriasis – January 27, 2020

January 27, 2020

Cosentyx (secukinumab) / Novartis
pINPOINt: A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD) (clinicaltrials.gov) – Jan 23, 2020 – P3; N=90; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

 

Stelara (ustekinumab) / J&J
The European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis (Businesswire) – Jan 23, 2020 – “The Janssen Pharmaceutical Companies…today announced that the European Commission (EC) has approved the expanded use of STELARA® (ustekinumab) for the treatment of paediatric patients (ages 6–11) with moderate to severe plaque psoriasis. Ustekinumab…is now the first available biologic treatment in this patient population to selectively address the IL‑23/IL‑12 pathway…Safety data from CADMUS Jr were consistent with the known safety profiles reflected in respective current prescribing information labels and ustekinumab was generally well‑tolerated by paediatric patients with plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie presents new risankizumab results that show long-term sustained efficacy [Google Translation] (ConSalud.es) – Jan 21, 2020 – P3, N=782; LIMMItless (NCT03047395); Sponsor: AbbVie; “…AbbVie has presented new long-term results of safety and efficacy of SKYRIZI….These new data, presented in the framework of the V National Psoriasis Congress organized by the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (AEDV), represent an advance in the treatment of adult patients with moderate to severe plaque psoriasis. The data presented within the LIMMItless study indicate that a statistically significant number of patients treated with risankizumab administered every 12 weeks continuously, achieved a complete or almost complete clearance after 136 weeks of treatment.”

 

Otezla (apremilast) / Amgen
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy (clinicaltrials.gov) – Jan 22, 2020 – P3; N=595; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales estimate: $275M in 2019; Skyrizi sales projection: $850M in 2020 and $3.4B in 2025 (Cowen & Co) – Jan 21, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 72; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

ABY-035 / Affibody
A double-blind study in subjects with active psoriatic arthritis to evaluate efficacy, tolerability, safety of two different dose levels of ABY-035 compared to placebo. (clinicaltrialsregister.eu) – Jan 21, 2020 – P2; N=129; Ongoing; Sponsor: Affibody AB

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab sales projection: $50M in 2021 and $250M in 2025 (Cowen & Co) – Jan 24, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 331; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales estimate: $3.545B in 2019; Cosentyx sales projection: $5B peak, $3.805B in 2020 and $5.075B in 2025 (Cowen & Co) – Jan 22, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 589; REPORT TITLE: – “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

Taltz (ixekizumab) / Eli Lilly
Taltz sales estimate: $1.325B in 2019; Taltz sales projection: $1.73B in 2020 and $3.215B in 2025 (Cowen & Co) – Jan 24, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 321; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

 

BMS-986165 / BMS
BMS-986165 sales projection: $50M in 2022 and $500M in 2025 (Cowen & Co) – Jan 23, 2020 – A subscription to Thomson ONE is required to gain full access to report 68638151; Page no: 260; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 01/13/2020

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Weekly Top News – Breast Cancer– January 20, 2020

January 20, 2020

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Acceptance of regulatory submission for HER2 + metastatic breast cancer in Q1 2020 (Macrogenics) – Jan 17, 2020 – Corporate Presentation: PDUFA action date for HER2 + metastatic breast cancer in Q4 2020 
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NeuVax (nelipepimut-S) / SELLAS Life Sciences; Keytruda (pembrolizumab) / Merck (MSD); Opdivo (nivolumab) / Ono Pharma, BMS
SELLAS highlights clinical development progress and expected 2020 milestones (GlobeNewswire) – Jan 13, 2020 – “Expected 2020 Clinical Milestones….First patient dosed in the Phase 3 registration-enabling study of GPS in AML patients in February 2020; First patient dosed in the Phase 1 open-label study of GPS with nivolumab in MPM patients in January 2020; Interim analysis of the Phase 1/2 basket study of GPS with pembrolizumab in multiple tumor types in the second half of 2020; Guidance from the FDA on the regulatory and development pathway for NPS in TNBC patients in the first quarter of 2020; Initial data from Phase 2 trial of NPS in DCIS in the first quarter of 2020.”

 

Ibrance (palbociclib) / Pfizer
NICE approves palbociclib with fulvestrant on the CDF for treatment of some breast cancers (European Pharmaceutical Review) – Jan 15, 2020 – “The UK National Institute for Health and Care Excellence (NICE) have approved a potentially life-extending drug combination, palbociclib (Ibrance) with fulvestrant. The drugs is for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer patients, who have already had endocrine therapy. The committee made palbociclib available via the Cancer Drug Fund (CDF) after hearing patient testimony and reviewing clinical trial evidence, suggesting that palbociclib with fulvestrant increases the length of time before the disease progresses, when compared to fulvestrant alone.”

 

Verzenio (abemaciclib) / Eli Lilly
Breast Cancer Network Australia welcomes new treatment drug on the PBS (Port Macquarie News) – Jan 14, 2020 – “Breast Cancer Network Australia has praised the federal government decision to list the drug Verzenio on the Pharmaceutical Benefits Scheme…Patients could be expected to pay up to $55,500 a year to access this medicine. As a result of this listing on the PBS, they will now only pay $41 per script, or, for concessional patients, just $6.60 per script.”

 

leronlimab (PRO 140) / CytoDyn, Vyera Pharma
CytoDyn files for Breakthrough Therapy Designation with the FDA for the use of leronlimab for the treatment of metastatic triple-negative breast cancer (GlobeNewswire) – Jan 13, 2020 – “CytoDyn Inc…announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC). The BTD filing is based on data from the first patient in the Company’s mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).”

 

ZW25 / Zymeworks; Ibrance (palbociclib) / Pfizer
Zymeworks announces agreement with Pfizer and initiation of a new phase 2 trial evaluating ZW25 in combination with Ibrance (palbociclib) (Businesswire) – Jan 12, 2020 – “Zymeworks Inc….announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib….The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned….Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.”

 

Bria-IMT (SV-BR-1-GM) / BriaCell; Keytruda (pembrolizumab) / Merck (MSD)
BriaCell provides update on remarkable responder (GlobeNewswire, BriaCell Therapeutics Corp) – Jan 13, 2020 – “BriaCell Therapeutics Corp….is pleased to provide an update on the previously-announced…top responder (‘Remarkable Responder’) in the combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012, a PD-1 inhibitor. The patient, who had experienced notable tumor shrinkage while on treatment with Bria-IMT™ in combination with the PD-1 inhibitor pembrolizumab…has since transitioned to treatment in combination with INCMGA00012. On this combination treatment, the patient has had a subsequent further remarkable reduction in a breast cancer tumor behind the left eye in the left orbital region. This tumor, which had pushed the eye forward from the skull (known as proptosis), has resolved following 3 months of treatment. The tumor had shrunk by 19% during treatment with the Bria-IMT™ regimen in combination with KEYTRUDA®, and has now completely disappeared during treatment in combination INCMGA00012.”

 

Tecentriq (atezolizumab) / Roche; Opdivo (nivolumab) / Ono Pharma, BMS; Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals provides 2020 goals and financial guidance (Businesswire) – Jan 13, 2020 – “2020 IPI-549 Development Guidance: MARIO-275 enrollment completion…Phase 2 study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo® in platinum-refractory, I/O naïve patients with advanced urothelial cancer. Data is expected in mid-2021; MARIO-3 enrollment completion and initial data…Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in triple negative breast cancer (TNBC) and with Tecentriq and Avastin® in renal cell cancer (RCC).”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab sales projection: $279M peak for 3L metastatic breast cancer (Infinata) – Jan 14, 2020 – A subscription to Thomson ONE is required to gain full access to report 68635802; Page no: 13; REPORT TITLE: – “Seattle Genetics, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 01/13/2020

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Weekly Top News – IBD– January 20, 2020

January 20, 2020

mirikizumab (LY3074828) / Eli Lilly
VIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Jan 18, 2020 – P3; N=778; Not yet recruiting; Sponsor: Eli Lilly and Company

 

filgotinib (GLPG0634) / Gilead
Filgotinib US regulatory estimate: Submission for ulcerative colitis in H2 2020 (Wells Fargo) – Jan 18, 2020 – A subscription to Thomson ONE is required to gain full access to report 68595639; Page no: 21; REPORT TITLE: “Biotech sector outlook – Fundamental/strategic value outweighs E”; AUTHOR: Birenchenough, James, et al; DATE: 01/05/2020

 

etrasimod (APD334) / Arena
Etrasimod: Data from P3 trial for Crohn’s disease in 2022 (Arena) – Jan 16, 2020 – Corporate Presentation
P3 data
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etrasimod (APD334) / Arena
Etrasimod: Completion of enrollment of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in 2020 (Arena) – Jan 16, 2020 – Corporate Presentation: Data from P3 ELEVATE UC 12 trial (NCT03996369) for ulcerative colitis in 2021 
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etrasimod (APD334) / Arena
Etrasimod: NDA submission for ulcerative colitis in 2022 (Arena) – Jan 16, 2020 – Corporate Presentation 
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etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn’s Disease (clinicaltrialsregister.eu) – Jan 16, 2020 – P2; N=225; Ongoing; Sponsor: Arena Pharmaceuticals Inc.

 

Entyvio (vedolizumab) / Takeda
Takeda’s Quintiles [sic] expands indication for ulcerative colitis, Crohn’s disease (Korea Biomedical Review) – Jan 17, 2020 – “The Ministry of Food and Drug Safety recently granted the nod to Quintiles [sic] (ingredient: vedolizumab) as the first-line therapy for ulcerative colitis and Crohn’s disease….In recent trials, Quintiles [sic] showed statistically superior clinical remission, compared to existing TNF-alpha inhibitors.”

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 15, 2020 – P3; N=101; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed; Trial completion date: Sep 2020 –> Dec 2019; Trial primary completion date: Jun 2020 –> Dec 2019

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 18, 2020 – P3; N=101; Active, not recruiting; Sponsor: AbbVie; Completed –> Active, not recruiting

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz patent expiry: Late 2025 in US (RBC Capital Markets (Canada)) – Jan 17, 2020 – A subscription to Thomson ONE is required to gain full access to report 68599422; Page no: 13; REPORT TITLE: “Pfizer Inc. – P&L to inflect off more innovative high growth base; Initiate at OP, $46 target”; AUTHOR: Stanicky, Randall, et al; DATE: 01/06/2020

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Weekly Top News – Psoriasis– January 20, 2020

January 20, 2020

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

 

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

 

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

 

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

 

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

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Weekly Top News – Breast Cancer– January 13, 2020

January 13, 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu now available in U.S. for HER2 positive unresectable or metastatic breast cancer following two or more prior anti-HER2-based regimens (Businesswire) – Jan 6, 2020 – “Daiichi Sankyo Company, Limited…announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S….ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.”

 

margetuximab (MGAH 22) / MacroGenics
MacroGenics outlines corporate priorities for 2020 (GlobeNewswire, MacroGenics, Inc.) – Jan 9, 2020 – “Pending acceptance and review of the BLA submitted in December 2019 to the Food and Drug Administration (FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenics expects a Standard Review process in which the FDA will likely require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020…Initial safety and efficacy data are expected in the second half of 2020 from Module A of…phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer.”

 

letrozole / Generic mfg.; Kisqali (ribociclib) / Novartis
CompLEEment-1: Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC (clinicaltrials.gov) – Jan 8, 2020 – P3; N=3775; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial completion date: May 2021 –> Nov 2019

 

ZW25 / Zymeworks; Ibrance (palbociclib) / Pfizer
Zymeworks announces agreement with Pfizer and initiation of a new phase 2 trial evaluating ZW25 in combination with Ibrance (palbociclib) (Businesswire) – Jan 12, 2020 – “Zymeworks Inc….announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib….The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned….Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.”

 

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer; GDC-0077 / Roche
A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) – Jan 9, 2020 – P3; N=400; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting –> Recruiting

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals highlights 2020 clinical and corporate outlook (Syndax Press Release) – Jan 10, 2020 – “The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis…Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020.”

 

Verzenio (abemaciclib) / Eli Lilly
GSK’s Dovato, Sandoz’s Rixathon enter LatAm in Chile, Eli Lilly’s Verzenio tags along (GBI Health) – Jan 9, 2020 – “GBI analysis reveals that Chile’s Institute of Public Health (ISP) recently approved GlaxoSmithKline (GSK)’s antiretroviral Dovato (dolutegravir + lamivudine), Eli Lilly’s CDK4/CDK6 kinase inhibitor Verzenio (abemaciclib), and Novartis subsidiary Sandoz’s biosimilar Rixathon (rituximab). Dovato is indicated to treat HIV-1 infection, while Verzenio is approved for HR+/HER2- advanced or metastatic breast cancer, and Rixathon is used against granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), in addition to the indications approved for Roche’s originator MabThera, namely non-Hodgkin’s lymphoma (NHL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).”

 

Halaven (eribulin mesylate) / Eisai
Launch of anticancer agent Halaven in China (Eisai Press Release) – Jan 10, 2020 – “Eisai Co., Ltd…announced today that it has launched the in-house developed anticancer agent Halaven(R) (generic name: eribulin mesylate) in China…In a Phase III clinical study (EMBRACE) of Halaven versus treatment of physician’s choice (TPC) in 762 patients with advanced or recurrent breast cancer previously treated with an anthracycline and a taxane, Halaven showed an extended overall survival compared to TPC.”

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Weekly Top News – IBD– January 13, 2020

January 13, 2020

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis at year end 2021 (SVB Leerink) – Jan 6, 2020 – A subscription to Thomson ONE is required to gain full access to report 68502627; Page no: 72; REPORT TITLE: “2020 outlook for investing in healthcare”; AUTHOR: Sullivan, John, et al; DATE: 12/16/2019

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P2b/3 CULTIVATE trial (NCT04173273) for Crohn’s disease in H2 2021 (SVB Leerink) – Jan 6, 2020 – A subscription to Thomson ONE is required to gain full access to report 68502627; Page no: 72; REPORT TITLE: “2020 outlook for investing in healthcare”; AUTHOR: Sullivan, John, et al; DATE: 12/16/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; brazikumab (AMG 139) / Allergan
Mergers: Commission approves AbbVie’s acquisition of Allergan, subject to conditions (European Commission) – Jan 10, 2020 – “The European Commission has approved, under the EU Merger Regulation, the proposed acquisition of Allergan by AbbVie. The approval is conditional on the divestment of a product under development by Allergan to treat inflammatory bowel diseases….The Commission found that brazikumab is likely to compete closely with AbbVie’s risankizumab…To address the Commission’s competition concerns, AbbVie offered to divest brazikumab…including the development, manufacturing and marketing rights at worldwide level, to a purchaser that will continue the drug’s development.”

 

etrolizumab (RG7413) / Roche
HIBISCUS I: 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 #1) (clinicaltrials.gov) – Jan 6, 2020 – P3; N=351; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting –> Active, not recruiting

 

Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Belgium’s UCB raises 2019 forecasts after net sales beat in Q4 (Reuters) – Jan 10, 2020 – “Belgian drugmaker UCB raised its revenue and earnings per share guidance for 2019 on Friday, helped by better-than-expected net sales due to strong demand for its Cimzia…drugs in the fourth quarter. Full-year revenue is expected now at about 4.9 billion euros, above the previously expected range of 4.6–4.7 billion euros…it said in a statement.”

 

Humira (adalimumab) / Eisai, AbbVie
Why Humira’s price keeps rising despite FDA approval of generic competition (The Washington Post) – Jan 8, 2020 – “The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023….In a statement, it chose to focus on its ‘net price,’ the amount paid by insurance companies. ‘This is an increase in list price and represents a net price increase that is in line with the projected rate of inflation,’ the company said.”

 

Humira (adalimumab) / Eisai, AbbVie
In brief: Appeals court chips away at Abbvie’s Humira patent fortress (Reuters) – Jan 8, 2020 – “A federal appeals court on Tuesday upheld a ruling that invalidated some of Abbvie Inc’s patents on Humira…Affirming the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit said three Abbvie patents on Humira were invalid as obvious.”

 

foralumab (TZLS-401) / Tiziana Life Sciences
Tiziana reports phase 1 clinical data demonstrating oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, is well-tolerated in healthy volunteers (Businesswire) – Jan 9, 2020 – “Tiziana Life Sciences plc…is pleased to report completion of a Phase 1 clinical study of Foralumab…in healthy subjects. The proprietary oral formulation…was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial….All subjects completed the trial without any safety concerns at any of the doses.”

 

PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics achieves milestone in Janssen Biotech, Inc., collaboration (PRNewswire) – Jan 7, 2020 – “Protagonist Therapeutics, Inc….today announced the achievement of a research milestone under its worldwide license and research collaboration agreement with Janssen Biotech, Inc….for co-development activities with affiliate Janssen Research & Development, LLC, and commercialization of…PTG-200 (JNJ-67864238) and second generation peptides for all indications including inflammatory bowel disease (IBD).”

 

vidofludimus (IMU-838) / Immunic
CALDOSE-1: Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (clinicaltrials.gov) – Jan 9, 2020 – P2; N=240; Recruiting; Sponsor: Immunic AG; N=150 –> 240; Trial completion date: Dec 2027 –> Jun 2029; Trial primary completion date: Jan 2021 –> Jul 2022

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Weekly Top News – Psoriasis– January 13, 2020

January 13, 2020

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

 

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

 

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

 

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

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Weekly Top News – Breast Cancer– January 6, 2020

January 6, 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu now available in U.S. for HER2 positive unresectable or metastatic breast cancer following two or more prior anti-HER2-based regimens (Businesswire) – Jan 6, 2020 – “Daiichi Sankyo Company, Limited…announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S….ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.”

 

Tuoyi (toripalimab) / Shanghai Junshi Bioscience
Junshi Bio and CSPC Pharma disengage from Tuoyi/paclitaxel deal (GBI Health) – Dec 31, 2019 – “China-based CSPC Pharmaceutical Group Ltd (1093.HK) and Shanghai Junshi Biosciences Co Ltd have agreed to terminate a deal struck in June 2018 in relation to programmed death-1 (PD-1) monoclonal antibody (mAb) Tuoyi (toripalimab) combined with paclitaxel in treating breast cancer. The firms cite a ‘potential conflict of interests in terms of CSPC Pharma’s PD-1 mAb development’ as the reason for the cancellation…Per the termination agreement, the milestone payments and RMB 3.68 million (527,000) in clinical development expenses paid to Junshi Bio will not be refunded, and no further milestone payments will be made.”

 

Faslodex (fulvestrant) / AstraZeneca; AZD9833 / AstraZeneca
SERENA-2: A Comparative Study of AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer (clinicaltrials.gov) – Jan 2, 2020 – P2; N=288; Not yet recruiting; Sponsor: AstraZeneca

 

Imfinzi (durvalumab) / AstraZeneca, BMS
Imfinzi sales projection: $4.8B in 2025 (Cowen & Co) – Jan 3, 2020 – A subscription to Thomson ONE is required to gain full access to report 68527170; Page no: 7; REPORT TITLE: “Portfolio manager’s weekly – December 20, 2019”; AUTHOR: Cowen Research, et al; DATE: 12/20/2019

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