AU2015305413B2 - Lyophilized formulations for factor xa antidote - Google Patents

Lyophilized formulations for factor xa antidote Download PDF

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Publication number
AU2015305413B2
AU2015305413B2 AU2015305413A AU2015305413A AU2015305413B2 AU 2015305413 B2 AU2015305413 B2 AU 2015305413B2 AU 2015305413 A AU2015305413 A AU 2015305413A AU 2015305413 A AU2015305413 A AU 2015305413A AU 2015305413 B2 AU2015305413 B2 AU 2015305413B2
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Australia
Prior art keywords
seq
formulation
mannitol
arginine
sucrose
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AU2015305413A
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English (en)
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AU2015305413A1 (en
Inventor
Phuong M. Nguyen
Gregory A. Sacha
Juan Wang
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Alexion Pharmaceuticals Inc
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Alexion Pharmaceuticals Inc
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Publication of AU2015305413A1 publication Critical patent/AU2015305413A1/en
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Priority to AU2020289768A priority Critical patent/AU2020289768B2/en
Assigned to ALEXION PHARMACEUTICALS, INC. reassignment ALEXION PHARMACEUTICALS, INC. Request for Assignment Assignors: PORTOLA PHARMACEUTICALS, INC.
Priority to AU2024219698A priority patent/AU2024219698A1/en
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    • 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
    • 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
    • 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (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)
AU2015305413A 2014-08-20 2015-08-20 Lyophilized formulations for factor xa antidote Active AU2015305413B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2020289768A AU2020289768B2 (en) 2014-08-20 2020-12-16 Lyophilized formulations for factor Xa antidote
AU2024219698A AU2024219698A1 (en) 2014-08-20 2024-09-13 Lyophilized formulations for factor Xa antidote

Applications Claiming Priority (3)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2020289768A Division AU2020289768B2 (en) 2014-08-20 2020-12-16 Lyophilized formulations for factor Xa antidote

Publications (2)

Publication Number Publication Date
AU2015305413A1 AU2015305413A1 (en) 2017-03-23
AU2015305413B2 true AU2015305413B2 (en) 2020-09-24

Family

ID=55351266

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2015305413A Active AU2015305413B2 (en) 2014-08-20 2015-08-20 Lyophilized formulations for factor xa antidote
AU2020289768A Active 2038-07-03 AU2020289768B2 (en) 2014-08-20 2020-12-16 Lyophilized formulations for factor Xa antidote
AU2024219698A Pending AU2024219698A1 (en) 2014-08-20 2024-09-13 Lyophilized formulations for factor Xa antidote

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2020289768A Active 2038-07-03 AU2020289768B2 (en) 2014-08-20 2020-12-16 Lyophilized formulations for factor Xa antidote
AU2024219698A Pending AU2024219698A1 (en) 2014-08-20 2024-09-13 Lyophilized formulations for factor Xa antidote

Country Status (14)

Country Link
US (6) US20160237420A1 (enExample)
EP (2) EP3750556A1 (enExample)
JP (4) JP6742986B2 (enExample)
KR (3) KR20250150675A (enExample)
CN (2) CN113171447B (enExample)
AU (3) AU2015305413B2 (enExample)
CA (1) CA2961739C (enExample)
DK (1) DK3182993T3 (enExample)
EA (2) EA036091B1 (enExample)
ES (1) ES2814157T3 (enExample)
IL (2) IL250413B (enExample)
SG (1) SG11201701247RA (enExample)
WO (1) WO2016029061A1 (enExample)
ZA (1) ZA201701764B (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL3604510T3 (pl) * 2009-03-30 2025-07-28 Alexion Pharmaceuticals, Inc. Antidota na inhibitory czynnika xa i sposoby ich stosowania
KR20250150675A (ko) * 2014-08-20 2025-10-20 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형
CN108883160B (zh) 2016-02-24 2022-06-28 博尔托拉制药公司 因子xa解毒剂的冻干制剂
EP3926044B1 (en) 2016-06-17 2025-06-04 Alexion Pharmaceuticals, Inc. Preparation of factor xa derivatives
EP3624828B1 (en) * 2017-05-18 2024-08-07 Merck Sharp & Dohme LLC Pharmaceutical formulation comprising incretin-insulin conjugates
JP7549530B2 (ja) * 2018-05-21 2024-09-11 中外製薬株式会社 ガラス容器に封入された凍結乾燥製剤
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 (5)

* Cited by examiner, † Cited by third party
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US20090098119A1 (en) * 2007-09-28 2009-04-16 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
US20100255000A1 (en) * 2007-09-28 2010-10-07 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
US20110015128A1 (en) * 2009-07-15 2011-01-20 Portola Pharmaceuticals, Inc. Unit dose formulation of antidotes for factor xa inhibitors and methods of using the same
WO2011131720A1 (en) * 2010-04-20 2011-10-27 Octapharma Ag New stabilizing agent for pharmaceutical proteins
WO2013049804A1 (en) * 2011-09-30 2013-04-04 The Children's Hospital Of Philadelphia Compositions and methods for modulating hemostasis

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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
EP1820516B1 (en) * 1999-02-22 2013-07-24 University of Connecticut Novel albumin-free factor VIII formulations
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
PT1589949E (pt) * 2003-01-08 2008-11-06 Novartis Vaccines & Diagnostic Composições liofilizadas estabilizadas compreendendo inibidor da coagulação por factores tecidulares ou variante de inibidor da coagulação por factores tecidulares
CN101304971B (zh) 2005-11-08 2011-09-07 米伦纽姆医药公司 Xa因子抑制剂n-(5-氯-2-吡啶基)-2-[[4-[(二甲氨基)亚氨基甲基]苯甲酰基]氨基]-5-甲氧基-苯甲酰胺的医药盐和多晶型
US9283260B2 (en) * 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
KR101691070B1 (ko) 2008-09-03 2016-12-29 옥타파마 아게 재조합에 의해 제조된 인자 ⅷ을 위한 신규한 보호 조성물
CA2743496C (en) * 2008-11-14 2018-03-27 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same in combination with blood coagulating agents
WO2011017070A1 (en) * 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
WO2011088152A1 (en) * 2010-01-12 2011-07-21 Portola Pharmaceuticals, Inc. Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof
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
KR20250150675A (ko) * 2014-08-20 2025-10-20 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형

Patent Citations (5)

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Publication number Priority date Publication date Assignee Title
US20090098119A1 (en) * 2007-09-28 2009-04-16 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
US20100255000A1 (en) * 2007-09-28 2010-10-07 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
US20110015128A1 (en) * 2009-07-15 2011-01-20 Portola Pharmaceuticals, Inc. Unit dose formulation of antidotes for factor xa inhibitors and methods of using the same
WO2011131720A1 (en) * 2010-04-20 2011-10-27 Octapharma Ag New stabilizing agent for pharmaceutical proteins
WO2013049804A1 (en) * 2011-09-30 2013-04-04 The Children's Hospital Of Philadelphia Compositions and methods for modulating hemostasis

Also Published As

Publication number Publication date
KR20250150675A (ko) 2025-10-20
KR20170042776A (ko) 2017-04-19
EA201790415A1 (ru) 2017-08-31
ZA201701764B (en) 2020-10-28
AU2020289768A1 (en) 2021-01-21
EA202091385A3 (ru) 2021-06-30
IL276960B (en) 2022-04-01
EA202091385A2 (ru) 2021-03-31
EP3182993A1 (en) 2017-06-28
CN107073082A (zh) 2017-08-18
IL250413A0 (en) 2017-03-30
US20210284986A1 (en) 2021-09-16
KR102482517B1 (ko) 2022-12-28
SG11201701247RA (en) 2017-03-30
IL250413B (en) 2020-09-30
DK3182993T3 (da) 2020-09-21
JP2023158199A (ja) 2023-10-26
US20180320160A1 (en) 2018-11-08
CA2961739A1 (en) 2016-02-25
JP2022003101A (ja) 2022-01-11
AU2020289768B2 (en) 2024-06-13
EP3182993A4 (en) 2018-01-17
EA036091B1 (ru) 2020-09-25
US11028382B2 (en) 2021-06-08
US20250163399A1 (en) 2025-05-22
CN113171447B (zh) 2024-05-17
US20200299667A1 (en) 2020-09-24
EP3182993B1 (en) 2020-07-01
JP2019206595A (ja) 2019-12-05
AU2015305413A1 (en) 2017-03-23
CA2961739C (en) 2024-04-30
JP2017525704A (ja) 2017-09-07
KR20230007550A (ko) 2023-01-12
US20160237420A1 (en) 2016-08-18
CN107073082B (zh) 2021-04-30
JP6742986B2 (ja) 2020-08-19
AU2024219698A1 (en) 2024-10-03
WO2016029061A1 (en) 2016-02-25
KR102867491B1 (ko) 2025-10-01
JP7416549B2 (ja) 2024-01-17
ES2814157T3 (es) 2021-03-26
CN113171447A (zh) 2021-07-27
EP3750556A1 (en) 2020-12-16
IL276960A (en) 2020-10-29
US20200299668A1 (en) 2020-09-24

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PC Assignment registered

Owner name: ALEXION PHARMACEUTICALS, INC.

Free format text: FORMER OWNER(S): PORTOLA PHARMACEUTICALS, INC.