AU2021267146B2 - Treatments of prostate cancer with combinations of abiraterone acetate and niraparib - Google Patents

Treatments of prostate cancer with combinations of abiraterone acetate and niraparib

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Publication number
AU2021267146B2
AU2021267146B2 AU2021267146A AU2021267146A AU2021267146B2 AU 2021267146 B2 AU2021267146 B2 AU 2021267146B2 AU 2021267146 A AU2021267146 A AU 2021267146A AU 2021267146 A AU2021267146 A AU 2021267146A AU 2021267146 B2 AU2021267146 B2 AU 2021267146B2
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AU
Australia
Prior art keywords
abiraterone acetate
niraparib
prostate cancer
pharmaceutical formulation
gene
Prior art date
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Active
Application number
AU2021267146A
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English (en)
Other versions
AU2021267146A1 (en
Inventor
Johny BERTELS
Urbain Alfons C. DELAET
Paul J. A. Hartman Kok
Philip Erna H. HEYNS
Angela LOPEZ-GITLITZ
Katrien LUYTEN
Tatiana MARCOZZI
Thomas Ronald A. Quinten
Kaustubh Ramesh Tambwekar
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Janssen Pharmaceutica NV
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Janssen Pharmaceutica NV
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Application filed by Janssen Pharmaceutica NV filed Critical Janssen Pharmaceutica NV
Publication of AU2021267146A1 publication Critical patent/AU2021267146A1/en
Priority to AU2026202227A priority Critical patent/AU2026202227A1/en
Application granted granted Critical
Publication of AU2021267146B2 publication Critical patent/AU2021267146B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Oncology (AREA)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Epoxy Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2021267146A 2020-05-08 2021-05-07 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib Active AU2021267146B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2026202227A AU2026202227A1 (en) 2020-05-08 2026-03-23 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
EP20173749 2020-05-08
EP20173749.1 2020-05-08
US202163142919P 2021-01-28 2021-01-28
US63/142,919 2021-01-28
US202163174282P 2021-04-13 2021-04-13
US63/174,282 2021-04-13
PCT/EP2021/062186 WO2021224469A1 (en) 2020-05-08 2021-05-07 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib

Related Child Applications (1)

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AU2026202227A Division AU2026202227A1 (en) 2020-05-08 2026-03-23 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib

Publications (2)

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AU2021267146A1 AU2021267146A1 (en) 2023-01-19
AU2021267146B2 true AU2021267146B2 (en) 2026-04-23

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AU2021267146A Active AU2021267146B2 (en) 2020-05-08 2021-05-07 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib
AU2021269115A Pending AU2021269115A1 (en) 2020-05-08 2021-05-07 Treatment of prostate cancer with a combination of abiraterone acetate and niraparib
AU2021266409A Pending AU2021266409A1 (en) 2020-05-08 2021-05-07 Pharmaceutical formulations of abiraterone acetate and niraparib
AU2026202227A Pending AU2026202227A1 (en) 2020-05-08 2026-03-23 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib
AU2026202283A Pending AU2026202283A1 (en) 2020-05-08 2026-03-25 Treatment of prostate cancer with a combination of abiraterone acetate and niraparib

Family Applications After (4)

Application Number Title Priority Date Filing Date
AU2021269115A Pending AU2021269115A1 (en) 2020-05-08 2021-05-07 Treatment of prostate cancer with a combination of abiraterone acetate and niraparib
AU2021266409A Pending AU2021266409A1 (en) 2020-05-08 2021-05-07 Pharmaceutical formulations of abiraterone acetate and niraparib
AU2026202227A Pending AU2026202227A1 (en) 2020-05-08 2026-03-23 Treatments of prostate cancer with combinations of abiraterone acetate and niraparib
AU2026202283A Pending AU2026202283A1 (en) 2020-05-08 2026-03-25 Treatment of prostate cancer with a combination of abiraterone acetate and niraparib

Country Status (19)

Country Link
US (4) US20230226080A1 (https=)
EP (3) EP4146210A1 (https=)
JP (3) JP2023524808A (https=)
KR (3) KR20230008780A (https=)
CN (3) CN115515584A (https=)
AU (5) AU2021267146B2 (https=)
BR (3) BR112022021732A2 (https=)
CA (3) CA3177123A1 (https=)
CR (1) CR20220588A (https=)
EC (1) ECSP22085983A (https=)
IL (3) IL297984B2 (https=)
JO (3) JOP20220294A1 (https=)
MX (3) MX2022014003A (https=)
PE (1) PE20230830A1 (https=)
PH (3) PH12022553029A1 (https=)
TW (3) TWI905184B (https=)
UA (1) UA130040C2 (https=)
UY (3) UY39204A (https=)
WO (3) WO2021224467A1 (https=)

Families Citing this family (2)

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CA3243120A1 (en) * 2022-02-04 2023-08-10 Janssen Pharmaceutica Nv Niraparib and abiraterone acetate plus prednisone to improve clinical outcomes in patients with metastatic castration-resistant prostate cancer and changes in hormone receptor function (HRF)
WO2025027138A1 (en) * 2023-08-02 2025-02-06 Janssen Pharmaceutica Nv Combination of niraparib and abiraterone for use in the treatment of metastatic castration-resistant prostate cancer

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CN115515584A (zh) 2022-12-23
MX2022014003A (es) 2022-11-30
KR20230008783A (ko) 2023-01-16
TW202207926A (zh) 2022-03-01
CN115551506A (zh) 2022-12-30
AU2021269115A1 (en) 2023-01-19
JP2023524808A (ja) 2023-06-13
US20260097048A1 (en) 2026-04-09
WO2021224469A1 (en) 2021-11-11
IL297984A (en) 2023-01-01
CA3177137A1 (en) 2021-11-11
ECSP22085983A (es) 2022-12-30
PH12022553029A1 (en) 2024-05-13
AU2021266409A1 (en) 2023-01-19
UY39201A (es) 2021-11-30
JOP20220294A1 (ar) 2022-11-01
IL297991A (en) 2023-01-01
MX2022014005A (es) 2022-11-30
UY39203A (es) 2021-11-30
CA3177094A1 (en) 2021-11-11
JOP20220292A1 (ar) 2022-11-01
PH12022553013A1 (en) 2024-05-13
US20230218640A1 (en) 2023-07-13
UY39204A (es) 2021-11-30
AU2026202283A1 (en) 2026-04-09
CA3177123A1 (en) 2021-11-11
PE20230830A1 (es) 2023-05-19
EP4146209A1 (en) 2023-03-15
EP4146211A1 (en) 2023-03-15
CR20220588A (es) 2023-01-17
KR20230008780A (ko) 2023-01-16
BR112022021732A2 (pt) 2022-12-06
TW202207925A (zh) 2022-03-01
WO2021224467A1 (en) 2021-11-11
WO2021224471A1 (en) 2021-11-11
US20230226081A1 (en) 2023-07-20
CN115515583A (zh) 2022-12-23
AU2026202227A1 (en) 2026-04-09
JP2023524794A (ja) 2023-06-13
PH12022553030A1 (en) 2024-05-13
IL297984B2 (en) 2025-03-01
MX2022014004A (es) 2022-11-30
EP4146210A1 (en) 2023-03-15
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