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The Digest

Pharma news roundup and Larvol updates

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Month: December 2019

Weekly Top News – Breast Cancer– December 30, 2019

December 30, 2019

Piqray (alpelisib) / Novartis
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (clinicaltrials.gov) – Dec 23, 2019 – P3; N=548; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics announces FDA acceptance for filing of Biologics License Application resubmission for sacituzumab govitecan to treat metastatic triple-negative breast cancer (GlobeNewswire, Immunomedics, Inc.) – Dec 26, 2019 – “Immunomedics, Inc…today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
FDA approval of new breast cancer drug offers hope to patients with few options (Boston Herald) – Dec 27, 2019 – “A breast cancer drug that can provide a last resort option to patients who have run out of treatments has been granted accelerated approval from the Food and Drug Administration, a move that could provide a new standard of care for hundreds of thousands of women with the disease. The drug, called Enhertu, was recently granted approval for patients who have received two or more prior treatments for inoperable or metastatic HER2-positive breast cancer, a type of cancer that learns to resist the drugs designed to attack it….’It’s always really hard to know the options are getting thinner. There’s a lot we can do for HER2-positive breast cancer, though we do reach a time where there is little else we have to offer and I think having a drug like this provides a lot of hope,’ said Dr. Eric Winer…”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201 regulatory estimate: Approval for 3L+ HER2+ metastatic breast cancer in Q2 2020 (SVB Leerink) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502825; Page no: 8; REPORT TITLE: “2020 Outlook: Focus on next-generation compounds”; AUTHOR: Berens, Andrew, et al; DATE: 12/16/2019

 

tucatinib (ARRY-380) / Seattle Genetics
Seattle Genetics announces submission of tucatinib New Drug Application to the U.S. FDA for patients with locally advanced or metastatic HER2-positive breast cancer (Businesswire) – Dec 23, 2019 – “Seattle Genetics, Inc…announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial…”

 

Prescient Therapeutics receives encouraging efficacy results for leading cancer drug candidate PTX-200 (Small Caps) – Dec 23, 2019 – P2a, N=11; “Oncology company Prescient Therapeutics (ASX: PTX) has unveiled news of a high response rate to its PTX-200 leading drug candidate from a phase 2 breast cancer trial….In a statement to the market, Prescient said that it had received ‘encouraging efficacy results’ in a clinical trial being conducted by Professor Joseph Sparano…”

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PENELOPE-B trial (NCT01864746) for breast cancer in December 2020 and final completion in November 2023 (Morgan Stanley) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68513174; Page no: 48; REPORT TITLE: “Major Pharmaceuticals: 2020 Outlook: Growth and valuation encouraging”; AUTHOR: Risinger, David, et al; DATE: 12/18/2019

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; Keytruda (pembrolizumab) / Merck (MSD)
BRCA mutations and homologous recombination repair deficiency in treatment with niraparib combined with pembrolizumab—reply (JAMA Oncology) – Dec 26, 2019 – P1/2, N=121; TOPACIO (NCT02657889); Sponsor: Tesaro, Inc; “We thank Lin and colleagues for their comments and interest in the TOPACIO/KEYNOTE-162 (Niraparib in Combination With Pembrolizumab in Patients With Triple-Negative Breast Cancer or Ovarian Cancer) trial…we found that the ORR was comparable across all ovarian cancer biomarker subpopulations, with efficacy in patients without tBRCA mutations or HRR deficiency. In the TNBC population, the ORRs were higher in patients with tBRCA mutations as expected…”

 

Afinitor (everolimus) / Novartis
ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments (clinicaltrials.gov) – Dec 27, 2019 – P; N=200; Recruiting; Sponsor: National Taiwan University Hospital

 

Imfinzi (durvalumab) / AstraZeneca, BMS
Imfinzi sales projection: Consensus of $3.5B ($2B (US: >$1B) for advanced NSCLC, $600M for 1L SCLC) by 2024 (Shore Capital) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68483685; Page no: 5; REPORT TITLE: ” Shore Capital- Intial morning trading comments 12 December 2019”; AUTHOR: Stockbrokers Black, Clive, et al; DATE: 12/12/2019

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Weekly Top News – IBD– December 30, 2019

December 30, 2019

PF-06826647 / Pfizer
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis (clinicaltrials.gov) – Dec 24, 2019 – P2b; N=202; Not yet recruiting; Sponsor: Pfizer

 

filgotinib (GLPG0634) / Gilead
Filgotinib regulatory estimate: Approval for ulcerative colitis around mid-2020 (Barclays) – Dec 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68490284; Page no: 6, 1; REPORT TITLE: “Galapagos: Christmas comes early for GLPG holders – thoughts on the recent outperformance”; AUTHOR: Field, Emily, et al; DATE: 12/13/2019

 

filgotinib (GLPG0634) / Gilead
Gilead and Eisai enter into agreement in Japan for the co-promotion of the investigational rheumatoid arthritis therapy filgotinib, pending regulatory approval (Businesswire) – Dec 24, 2019 – “Gilead Sciences, Inc….and Eisai Co., Ltd….announced today that Gilead Sciences K.K. (Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib…in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.”

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200 regulatory estimate: Approval for Crohn’s disease in 2023 (BTIG) – Dec 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68441439; Page no: 7; REPORT TITLE: “Protagonist Therapeutics, Inc. – Sell off in shares on PTG-300 preliminary data in beta-thalassemia seems overdone”; AUTHOR: Chiang, Timothy, et al; DATE: 12/04/2019

 

Entyvio (vedolizumab) / Takeda
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study (clinicaltrials.gov) – Dec 23, 2019 – P4; N=60; Suspended; Sponsor: Takeda; Trial completion date: Jul 2019 –> Aug 2020; Recruiting –> Suspended; Trial primary completion date: Jul 2019 –> Aug 2020

 

Stelara (ustekinumab) / J&J
SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (clinicaltrials.gov) – Dec 26, 2019 – P3b; N=384; Active, not recruiting; Sponsor: Janssen Scientific Affairs, LLC; Recruiting –> Active, not recruiting

 

BBT-401 / Bridge Bio, Daewoong Pharma
Bridge Biotherapeutics announces China NMPA clearance of IND for BBT-401, a pellino-1 inhibitor for UC (PRNewswire) – Dec 26, 2019 – “Bridge Biotherapeutics Inc…announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) cleared the Investigational New Drug (IND) application submitted as of September 25, 2019 for BBT-401, a potent first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis (UC). Bridge Biotherapeutics plans to initiate a Phase I study of BBT-401 in Chinese subjects in May 2020…The study will include 30 healthy volunteers and is targeting to complete by end of 2020.”

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Xifaxan sales projection: $1.4B in 2019 (Guggenheim) – Dec 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502576; Page no: 8; REPORT TITLE: “Bausch Health Companies Ltd- BHC (Buy) – BHC (Buy) – Hepatic encephalopathy (HE) deep dive ahead of phase 2 data”; AUTHOR: Research Department; DATE: 12/16/2019

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $4,425M by 2025 (GlobalData) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 67577535; Page no: 71; REPORT TITLE: “Takeda Pharmaceutical Co Ltd (4502) – Financial and strategic SWOT analysis review”; AUTHOR: Globaldata; DATE: 12/18/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Xifaxan patent protection: Until 2031 for soluble solid dispersion tablets (Guggenheim) – Dec 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502576; Page no: 4; REPORT TITLE: “Bausch Health Companies Ltd- BHC (Buy) – Hepatic encephalopathy (HE) deep dive ahead of phase 2 data”; AUTHOR: Research Department; DATE: 12/16/2019

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Weekly Top News – Psoriasis– December 30, 2019

December 30, 2019

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – Breast Cancer– December 23, 2019

December 23, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Data from P3 IMpassion031 trial (NCT03197935) for neoadjuvant TNBC in H1 2020 (Roche) – Dec 17, 2019 – SABCS 2019 
[Screenshot]

 

margetuximab (MGAH 22) / MacroGenics
FDA approval sought for margetuximab in HER2+ metastatic breast cancer (OncLive) – Dec 20, 2019 – “MacroGenics, Inc. has submitted a biologics license application (BLA) for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer….’Margetuximab’s Fc engineering enhances both innate and adaptive immunity, creating a coordinated engagement of HER2-targeted immunity,’ added Rugo.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens (AstraZeneca Press Release) – Dec 20, 2019 – “AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) 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. This indication is approved under Accelerated Approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial…the FDA approval is based on the results of the registrational Phase II trial DESTINY-Breast01…”

 

margetuximab (MGAH 22) / MacroGenics
MacroGenics announces submission of margetuximab Biologics License Application to U.S. FDA (GlobeNewswire) – Dec 19, 2019 – “MacroGenics, Inc…announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study…”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201: “Median time to response was 1.6 months (95% CI, 1.4-2.6 months)”; Breast cancer (Daiichi Sankyo) – Dec 18, 2019 – R&D Day 2019: “Confirmed ORR: 60.9%a (95% CI, 53.4%–68.0%) 11 CRs” 
[Screenshot]

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at ASCO (May 29- June 02, 2020) (Daiichi Sankyo) – Dec 18, 2019 – Data presentation from P2 DESTINY-Gastric01 trial (NCT03329690) for HER2-overexpressing advanced gastric cancer at ASCO (May 29- June 02, 2020) 
[Screenshot]

 

Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; Tecentriq (atezolizumab) / Roche
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) – Dec 18, 2019 – P3; N=280; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting –> Recruiting

 

Kadcyla (ado-trastuzumab emtansine) / Roche
European Commission approves Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (Roche Press Release) – Dec 19, 2019 – “Roche…announced that the European Commission has approved 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…The approval of Kadcyla in Europe is based on results from the phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50%…”

 

tucatinib (ARRY-380) / Seattle Genetics; Herceptin (trastuzumab) / Roche; capecitabine / Generic mfg.
Seattle Genetics announces U.S. FDA grants Breakthrough Therapy Designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer (Businesswire) – Dec 18, 2019 – “Seattle Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1…’We intend to submit a New Drug Application to the FDA and an MAA to the EMA by the first quarter 2020’…This Breakthrough Therapy designation was based on data from the pivotal HER2CLIMB clinical trial…”

 

tucatinib (ARRY-380) / Seattle Genetics
Seattle Genetics announces submission of tucatinib New Drug Application to the U.S. FDA for patients with locally advanced or metastatic HER2-positive breast cancer (Businesswire) – Dec 23, 2019 – “Seattle Genetics, Inc…announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial…”

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Weekly Top News – IBD– December 23, 2019

December 23, 2019

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104: “Durable remission weeks 16-52: statistically significant benefit in durable remission on all visits, weeks 16-52, demonstrating an improvement of 100% over placebo”; Crohn’s disease (RedHill) – Dec 19, 2019 – Corporate Presentation 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Top-line data from P3 trials LUCENT 1 (NCT03518086), LUCENT 2 (NCT03524092) and LUCENT 3 (NCT03519945) for ulcerative colitis in 2020 (Eli Lilly) – Dec 18, 2019 – 2020 Financial Guidance Call 
[Screenshot]

 

Remsima SC (infliximab biosimilar SC) / Celltrion
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Dec 19, 2019 – P3; N=615; Not yet recruiting; Sponsor: Celltrion

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The Committee confirmed that all issues previously identified in this application had been addressed [extension application to introduce a new pharmaceutical form (prolonged-release tablet) associated with a new strength (11 mg), and presented in pack sizes of 28, 30, 90 and 91 tablets].” (EMEA) – Dec 20, 2019 – CHMP Final Minutes for the meeting on 14-17 October 2019: “The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.”

 

SHP647 / Takeda
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) (clinicaltrials.gov) – Dec 17, 2019 – P3; N=3384; Recruiting; Sponsor: Shire; N=2453 –> 3384

 

QBECO / Qu biologics
Qu Biologics Completes Enrollment in First Stage of Phase 2 Clinical Trial in Moderate to Severe Crohn’s Disease (GlobeNewswire, Qu Biologics, Inc.) – Dec 18, 2019 – “Qu Biologics Inc…is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, ‘A Phase 2…Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease’. In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function.”

 

ravagalimab (ABBV-323) / AbbVie
A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) – Dec 19, 2019 – P2; N=30; Recruiting; Sponsor: AbbVie; N=60 –> 30; Trial completion date: May 2022 –> Nov 2021

 

ABX464 / Abivax
Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients Odslepená udržiavacia liečba pacientov so stredne závažnou až závažnou ulceróznou kolitídou (clinicaltrialsregister.eu) – Dec 19, 2019 – P2; N=232; Ongoing; Sponsor: ABIVAX

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Weekly Top News – Psoriasis– December 23, 2019

December 23, 2019

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

 

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – Breast Cancer– December 16, 2019

December 16, 2019

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Wolfe Research) – Dec 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 68433460; Page no: 66; REPORT TITLE: “Global Pharmaceuticals – Dec 2019 issue of “monthly controversies” report “; AUTHOR: Anderson, Tim, et al; DATE: 12/02/2019

 

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer
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) – Dec 9, 2019 – P3; N=400; Not yet recruiting; Sponsor: Hoffmann-La Roche

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in late 2020 (Wolfe Research) – Dec 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 68433460; Page no: 66; REPORT TITLE: “Global Pharmaceuticals – Dec 2019 issue of “monthly controversies” report “; AUTHOR: Anderson, Tim, et al; DATE: 12/02/2019

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: “In this study, shorter margetuximab infusion times starting from C2 appear to be well tolerated”; Breast cancer (Macrogenics) – Dec 12, 2019 – SABCS 2019: “94% of IRRs occurred during C1 with the 120-minute infusion” 
[Screenshot]

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche
MacroGenics presents results from the SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer at the San Antonio Breast Cancer Symposium (GlobeNewswire) – Dec 11, 2019 – P3, N=624; SOPHIA (NCT02492711); Sponsor: MacroGenics; “MacroGenics…presented updated results from the Phase 3 SOPHIA study comparing margetuximab plus chemotherapy versus trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer…Overall survival (OS) results favored margetuximab plus chemotherapy compared with trastuzumab and chemotherapy in the intention-to-treat (ITT) population; however, these data did not reach statistical significance at this second interim analysis as of a September 2019 cut-off after 270 events (median OS=21.6 months versus 19.8 months; hazard ratio [HR]=0.89; 95% CI: 0.69-1.13; P=0.326)…’We….look forward to submitting a BLA to the FDA, which we expect to occur before the end of the year.'”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: “Primary analysis (Oct-2018 cutoff): 24% risk reduction in centrally blinded PFS (HR 0.76, P=0.033)”; Breast cancer (Macrogenics) – Dec 12, 2019 – SABCS 2019: “2nd interim OS (Sep-2019 cutoff): favors margetuximab (mOS 21.6 vs 19.8 mos; HR=0.89, P=0.326)” 
[Screenshot]

 

Keytruda (pembrolizumab) / Merck (MSD)
OncoSec presents interim data of 28.5% objective response rate (ORR) from ongoing KEYNOTE-890 study evaluating Tavo in combination with Keytruda for heavily pretreated, late-stage, metastatic triple negative breast cancer (mTNBC) at the 2019 San Antonio Breast Cancer Symposium (PRNewswire) – Dec 13, 2019 – P2, N=25; KEYNOTE-890 (NCT03567720); Sponsor: OncoSec Medical Incorporated; “Four of the 14 patients showed a rapid tumor reduction and had a confirmed partial response by RECIST v1.1 (ORR 28.5%), including a deep partial response in a patient with multiple liver, bone, skin and nodal metastases and a short disease-free interval following neoadjuvant chemotherapy. All responses are ongoing (range: 6 to 9 months) and a median duration of response (DOR) has not yet been reached…Stable disease was observed in three patients (21.4%), with two stable disease patients reporting 20% or greater tumor shrinkage…Additionally, 3 of the 4 responding patients’ lesions were PD-L1 negative by IHC analysis before treatment (1 patient was undetermined)…Importantly, TAVO and pembrolizumab were well tolerated, with only 3 of 16 patients experiencing grade 3 treatment-related adverse events with combination treatment….OncoSec expects to report the full data results in 2020.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
[Fam]-trastuzumab deruxtecan achieved a tumor response of 60.9% in pivotal phase II HER2-positive metastatic breast cancer trial (Businesswire) – Dec 11, 2019 – P2, N=230; DESTINY-Breast01 (NCT03248492); Sponsor: Daiichi Sankyo, Inc; “AstraZeneca and Daiichi Sankyo Company, Limited…presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of [fam]-trastuzumab deruxtecan (DS-8201)….Patients achieved a disease control rate (DCR) of 97.3% with a median duration of response (DoR) of 14.8 months (range: 13.8 – 16.9) and median progression-free survival of 16.4 months (range: 12.7 – not reached). The median overall survival (OS) has not yet been reached with an estimated survival rate for patients receiving [fam]-trastuzumab deruxtecan of 86% at one year.”

 

Kisqali (ribociclib) / Novartis
Overall survival with ribociclib plus fulvestrant in advanced breast cancer (NEJM) – Dec 11, 2019 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P=0.00455). The benefit was consistent across most subgroups.”

 

Kisqali (ribociclib) / Novartis
Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial (Lancet Oncol) – Dec 11, 2019 – P2, N=106; CORALLEEN (NCT03248427); “At baseline, of the 106 patients, 92 (87%) patients had high ROR disease (44 [85%] of 52 in the ribociclib and letrozole group and 48 [89%] of 54 in the chemotherapy group) and 14 (13%) patients had intermediate-ROR disease (eight [15%] and six [11%]). Median follow-up was 200·0 days (IQR 191·2–206·0). At surgery, 23 (46·9%; 95% CI 32·5–61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9–61·5) of 52 patients in the chemotherapy group were low-ROR.”

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Weekly Top News – IBD– December 16, 2019

December 16, 2019

Xeljanz XR (tofacitinib XR) / Pfizer
FDA approves Xeljanz XR (tofacitinib) extended-release tablets for the treatment of ulcerative colitis (Pfizer Press Release) – Dec 12, 2019 – “Pfizer Inc…announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers.”

 

TD-1473 / J&J
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) – Dec 11, 2019 – P2/3; N=500; Not yet recruiting; Sponsor: Theravance Biopharma; Initiation date: Nov 2019 –> Feb 2020

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
ADAPT: An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease (clinicaltrials.gov) – Dec 9, 2019 – P4; N=55; Terminated; Sponsor: Janssen Scientific Affairs, LLC; Completed –> Terminated; Study was terminated due to the inability to enroll a sufficient number of the required subject population

 

NI-071 (infliximab biosimilar) / Sanofi, Nichi-Iko, Binex, Aprogen
Korea’s 11th unicorn company ‘Aprogen’ is the only biotechnology company [Google Translation] (Sisaweek) – Dec 10, 2019 – “…the company has successfully developed ‘GS071’ (Japan NI071), a biosimilar that is used to treat autoimmune diseases such as rheumatoid arthritis and Crohn’s disease…Aprogen plans to apply for the GS071 in the US next year and obtain a US product approval in 2021.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $178M in Q4 2019 (UBS) – Dec 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68424496; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/29/2019

 

ozanimod (RPC1063) / BMS
Ozanimod sales projection: Consensus of $1B in 2022 (William O Neil) – Dec 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 68456923; Page no: 5; REPORT TITLE: “WON Global view — December 6, 2019”; AUTHOR: Research Department; DATE: 12/06/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq WW sales projection: $530M in 2020, $1,004M in 2021 and $1,963M in 2022 (Piper Jaffray) – Dec 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68437953; Page no: 1; REPORT TITLE: “Abbvie Inc – New rheumatologist survey indicates Rinvoq is trending ahead of expectations”; AUTHOR: Raymond, Christopher, et al; DATE: 12/03/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Alberta will force patients to switch from biologics to cheaper biosimilar medications (The Globe and Mail) – Dec 12, 2019 – “Alberta will force 26,000 patients on government-sponsored drug plans to switch from expensive drugs that are known as biologics to cheaper near-copies of the medications, a move that will save the province hundreds of millions of dollars in the coming years…Alberta’s plan will require existing patients on government-sponsored drug plans to switch to the biosimilar versions of Remicade….The changes, which kick in July 1, 2020, do not apply to patients with private insurance or patients who pay out of pocket for their prescription drugs.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn’s Disease Who Failed Prior Biologic Treatment (clinicaltrials.gov) – Dec 9, 2019 – P3; N=579; Recruiting; Sponsor: AbbVie; Trial completion date: Jun 2020 –> Mar 2021; Trial primary completion date: Jun 2020 –> Mar 2021

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Weekly Top News – Psoriasis– December 16, 2019

December 16, 2019

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – Breast Cancer– December 9, 2019

December 9, 2019

BAT8001 / Bio-Thera Solutions
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer (clinicaltrials.gov) – Dec 4, 2019 – P3; N=410; Active, not recruiting; Sponsor: Bio-Thera Solutions

 

Piqray (alpelisib) / Novartis
Alpelisib: Initiation of P3 trials for HER2+ breast cancer/TNBC/ovarian cancer/head and neck cancer in 2020 (Novartis) – Dec 6, 2019 – R&D Day 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Foundation Medicine expands indication for FoundationOne CDx as a companion diagnostic for Piqray (alpelisib) (Businesswire) – Dec 4, 2019 – “Foundation Medicine, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.”

 

Piqray (alpelisib) / Novartis
Alpelisib: Regulatory submissions for TNBC/HER2+ advance breast cancer in 2023 (Novartis) – Dec 6, 2019 – R&D Day: Regulatory submission for ovarian cancer in 2023; Regulatory submission for 2L/3L HNSCC in 2024 
[Screenshot]

 

Keytruda (pembrolizumab) / Merck (MSD)
OncoSec to present interim data from ongoing KEYNOTE-890 study of TAVO and Keytruda in late-stage metastatic triple negative breast cancer at the 2019 San Antonio Breast Cancer Symposium (PRNewswire) – Dec 5, 2019 – “OncoSec Medical Incorporated….announced it will present interim efficacy, immunological and safety data from its ongoing KEYNOTE-890 study of TAVO™ in combination with KEYTRUDA® in patients with late-stage, heavily pretreated, chemo-refractory metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held December 10-14, 2019.”

 

Kisqali (ribociclib) / Novartis
Kisqali: Regulatory submission for HR+, HER2(-) breast cancer (adjuvant) in 2022 (Novartis) – Dec 6, 2019 – R&D Day 
[Screenshot]

 

Nerlynx (neratinib) / Puma, Knight Therap
Puma Biotechnology licensing partner specialised therapeutics receives marketing approval in Singapore for Nerlynx (neratinib) for extended adjuvant treatment of early stage hormone receptor positive HER2-positive breast cancer (Businesswire) – Dec 2, 2019 – “Puma Biotechnology…has received marketing approval of NERLYNX® (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government. NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.” ”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals phase 2 triple negative breast cancer data selected for Spotlight Session at San Antonio Breast Cancer Symposium (GlobeNewswire) – Dec 4, 2019 – “Biothera Pharmaceuticals, Inc. today announced that response and clinical benefit data from its Phase 2 study of dectin-1 agonist Imprime PGG in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in chemo-refractory metastatic triple negative breast cancer patients have been selected for a poster discussion Spotlight Session on December 11 at the 2019 San Antonio Breast Cancer Symposium.”

 

Verzenio (abemaciclib) / Eli Lilly
Eli Lilly stretches 2019 Verzenio approvals streak with Peru nod (GBI Health) – Dec 6, 2019 – “GBI analysis reveals that Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) this week granted Eli Lilly market approval for its kinase inhibitor Verzenio (abemaciclib). The oral therapy is designed to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, although the agency does not release indication details.”

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics resubmits Biologics License Application to the FDA for sacituzumab govitecan (GlobeNewswire) – Dec 3, 2019 – “Immunomedics, Inc…today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.”

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