KR102867491B1 - 인자 xa 해독제용 동결건조된 제형 - Google Patents

인자 xa 해독제용 동결건조된 제형

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Publication number
KR102867491B1
KR102867491B1 KR1020227045749A KR20227045749A KR102867491B1 KR 102867491 B1 KR102867491 B1 KR 102867491B1 KR 1020227045749 A KR1020227045749 A KR 1020227045749A KR 20227045749 A KR20227045749 A KR 20227045749A KR 102867491 B1 KR102867491 B1 KR 102867491B1
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KR
South Korea
Prior art keywords
seq
formulation
mannitol
arginine
chain
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
KR1020227045749A
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English (en)
Korean (ko)
Other versions
KR20230007550A (ko
Inventor
쥐안 왕
그레고리 에이 사샤
푸옹 엠 응우옌
Original Assignee
포톨라 파마슈티컬스, 인코포레이티드
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Priority to KR1020257032508A priority Critical patent/KR20250150675A/ko
Publication of KR20230007550A publication Critical patent/KR20230007550A/ko
Application granted granted Critical
Publication of KR102867491B1 publication Critical patent/KR102867491B1/ko
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Classifications

    • 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
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6432—Coagulation factor Xa (3.4.21.6)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21006—Coagulation factor Xa (3.4.21.6)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
KR1020227045749A 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형 Active KR102867491B1 (ko)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020257032508A KR20250150675A (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462039809P 2014-08-20 2014-08-20
US62/039,809 2014-08-20
KR1020177007503A KR102482517B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
PCT/US2015/046173 WO2016029061A1 (en) 2014-08-20 2015-08-20 Lyophilized formulations for factor xa antidote

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020177007503A Division KR102482517B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Related Child Applications (1)

Application Number Title Priority Date Filing Date
KR1020257032508A Division KR20250150675A (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Publications (2)

Publication Number Publication Date
KR20230007550A KR20230007550A (ko) 2023-01-12
KR102867491B1 true KR102867491B1 (ko) 2025-10-01

Family

ID=55351266

Family Applications (3)

Application Number Title Priority Date Filing Date
KR1020227045749A Active KR102867491B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
KR1020177007503A Active KR102482517B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
KR1020257032508A Pending KR20250150675A (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Family Applications After (2)

Application Number Title Priority Date Filing Date
KR1020177007503A Active KR102482517B1 (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형
KR1020257032508A Pending KR20250150675A (ko) 2014-08-20 2015-08-20 인자 xa 해독제용 동결건조된 제형

Country Status (14)

Country Link
US (6) US20160237420A1 (https=)
EP (2) EP3750556A1 (https=)
JP (4) JP6742986B2 (https=)
KR (3) KR102867491B1 (https=)
CN (2) CN113171447B (https=)
AU (3) AU2015305413B2 (https=)
CA (1) CA2961739C (https=)
DK (1) DK3182993T3 (https=)
EA (2) EA036091B1 (https=)
ES (1) ES2814157T3 (https=)
IL (2) IL250413B (https=)
SG (1) SG11201701247RA (https=)
WO (1) WO2016029061A1 (https=)
ZA (1) ZA201701764B (https=)

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EP3121271B1 (en) * 2009-03-30 2019-07-24 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
EP3750556A1 (en) * 2014-08-20 2020-12-16 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
WO2017147522A1 (en) * 2016-02-24 2017-08-31 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
PT3472314T (pt) * 2016-06-17 2021-06-18 Alexion Pharma Inc Preparação de derivados do fator xa
WO2018213151A1 (en) * 2017-05-18 2018-11-22 Merck Sharp & Dohme Corp. Pharmaceutical formulation comprising incretin-insulin conjugates
CN112512480B (zh) * 2018-05-21 2024-10-01 中外制药株式会社 被封入玻璃容器的冷冻干燥制剂
CN110760479A (zh) * 2019-05-17 2020-02-07 上海交通大学医学院附属瑞金医院 靶向血小板表达的凝血因子Xa及其应用

Citations (4)

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Publication number Priority date Publication date Assignee Title
US20100255000A1 (en) 2007-09-28 2010-10-07 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
WO2011017070A1 (en) 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
WO2013049804A1 (en) 2011-09-30 2013-04-04 The Children's Hospital Of Philadelphia Compositions and methods for modulating hemostasis
KR102482517B1 (ko) * 2014-08-20 2022-12-28 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형

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JPH08504769A (ja) 1992-12-15 1996-05-21 コルバス・インターナショナル、インコーポレイテッド 因子Ｘａの新規インヒビター
DK1820516T3 (da) * 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
WO2001064642A2 (en) 2000-02-29 2001-09-07 Cor Therapeutics, Inc. Benzamides and related inhibitors of factor xa
US6586584B2 (en) * 2001-01-29 2003-07-01 Becton, Dickinson And Company Sequences and methods for detection of Hepatitis C virus
CA2512680A1 (en) * 2003-01-08 2004-07-29 Chiron Corporation Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants
PE20070717A1 (es) 2005-11-08 2007-08-17 Millennium Pharm Inc Sal de maleato y polimorfo de [2-({4-[(dimetilamino)iminometil]fenil}carbonilamino)-5-metoxifenil]-n-(5-cloro-(2-piridil))carboxamida
US9283260B2 (en) * 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
EP2915564B1 (en) * 2007-09-28 2020-11-04 Portola Pharmaceuticals, Inc. Antidotes for factor XA inhibitors and methods of using the same
WO2010026186A1 (en) 2008-09-03 2010-03-11 Octapharma Ag New protecting compositions for recombinantly produced factor viii
MX2011004907A (es) * 2008-11-14 2011-07-29 Portola Pharm Inc Antidotos para inhibidores del factor xa y metodos para el uso de los mismos en combinacion con agentes de coagulacion de sangre.
ES2605801T3 (es) * 2009-07-15 2017-03-16 Portola Pharmaceuticals, Inc. Formulación de dosis unitaria de antídoto para inhibidores del factor Xa para su uso en la prevención de la hemorragia
US20130165459A1 (en) * 2010-01-12 2013-06-27 Norvartis Pharma Ag Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof
CA2796729C (en) * 2010-04-20 2020-06-23 Octapharma Ag Melezitose for stabilizing human blood plasma proteins
JP2013544271A (ja) * 2010-12-03 2013-12-12 ポートラ ファーマシューティカルズ， インコーポレイテッド 式（ｉ）の化合物の薬学的組成物、投薬形態、および新規の形態、ならびにその使用方法
US9683020B2 (en) * 2011-08-01 2017-06-20 Emory University VLPS containing ligands and methods related thereto
GB201310946D0 (en) * 2013-06-19 2013-07-31 Cambridge Entpr Ltd Antidote

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100255000A1 (en) 2007-09-28 2010-10-07 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
WO2011017070A1 (en) 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
WO2013049804A1 (en) 2011-09-30 2013-04-04 The Children's Hospital Of Philadelphia Compositions and methods for modulating hemostasis
KR102482517B1 (ko) * 2014-08-20 2022-12-28 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형

Also Published As

Publication number Publication date
AU2015305413B2 (en) 2020-09-24
JP6742986B2 (ja) 2020-08-19
JP2017525704A (ja) 2017-09-07
KR102482517B1 (ko) 2022-12-28
US20180320160A1 (en) 2018-11-08
KR20250150675A (ko) 2025-10-20
DK3182993T3 (da) 2020-09-21
JP2023158199A (ja) 2023-10-26
CN107073082A (zh) 2017-08-18
US20200299668A1 (en) 2020-09-24
AU2020289768B2 (en) 2024-06-13
IL250413B (en) 2020-09-30
US20210284986A1 (en) 2021-09-16
EP3750556A1 (en) 2020-12-16
KR20230007550A (ko) 2023-01-12
JP7416549B2 (ja) 2024-01-17
CN107073082B (zh) 2021-04-30
WO2016029061A1 (en) 2016-02-25
EA202091385A3 (ru) 2021-06-30
KR20170042776A (ko) 2017-04-19
AU2020289768A1 (en) 2021-01-21
JP2019206595A (ja) 2019-12-05
EA202091385A2 (ru) 2021-03-31
CN113171447B (zh) 2024-05-17
IL276960A (en) 2020-10-29
CA2961739C (en) 2024-04-30
IL276960B (en) 2022-04-01
EA036091B1 (ru) 2020-09-25
CA2961739A1 (en) 2016-02-25
IL250413A0 (en) 2017-03-30
AU2015305413A1 (en) 2017-03-23
ZA201701764B (en) 2020-10-28
SG11201701247RA (en) 2017-03-30
JP2022003101A (ja) 2022-01-11
AU2024219698A1 (en) 2024-10-03
US20160237420A1 (en) 2016-08-18
EP3182993A4 (en) 2018-01-17
ES2814157T3 (es) 2021-03-26
EP3182993A1 (en) 2017-06-28
US11028382B2 (en) 2021-06-08
CN113171447A (zh) 2021-07-27
EP3182993B1 (en) 2020-07-01
EA201790415A1 (ru) 2017-08-31
US20200299667A1 (en) 2020-09-24
US20250163399A1 (en) 2025-05-22

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