ES2814157T3 - Formulaciones liofilizadas para antídoto del factor Xa - Google Patents

Formulaciones liofilizadas para antídoto del factor Xa Download PDF

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Publication number
ES2814157T3
ES2814157T3 ES15834421T ES15834421T ES2814157T3 ES 2814157 T3 ES2814157 T3 ES 2814157T3 ES 15834421 T ES15834421 T ES 15834421T ES 15834421 T ES15834421 T ES 15834421T ES 2814157 T3 ES2814157 T3 ES 2814157T3
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ES
Spain
Prior art keywords
formulation
mannitol
arginine
sucrose
seq
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Application number
ES15834421T
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English (en)
Spanish (es)
Inventor
Juan Wang
Gregory A Sacha
Phuong M Nguyen
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Portola Pharmaceuticals LLC
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Portola Pharmaceuticals LLC
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Publication of ES2814157T3 publication Critical patent/ES2814157T3/es
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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6432Coagulation factor Xa (3.4.21.6)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21006Coagulation 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
ES15834421T 2014-08-20 2015-08-20 Formulaciones liofilizadas para antídoto del factor Xa Active ES2814157T3 (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
ES2814157T3 true ES2814157T3 (es) 2021-03-26

Family

ID=55351266

Family Applications (1)

Application Number Title Priority Date Filing Date
ES15834421T Active ES2814157T3 (es) 2014-08-20 2015-08-20 Formulaciones liofilizadas para antídoto del factor Xa

Country Status (14)

Country Link
US (6) US20160237420A1 (enExample)
EP (2) EP3750556A1 (enExample)
JP (4) JP6742986B2 (enExample)
KR (3) KR102867491B1 (enExample)
CN (2) CN113171447B (enExample)
AU (3) AU2015305413B2 (enExample)
CA (1) CA2961739C (enExample)
DK (1) DK3182993T3 (enExample)
EA (2) EA202091385A3 (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
LT3604510T (lt) * 2009-03-30 2025-07-10 Alexion Pharmaceuticals, Inc. Faktoriaus xa inhibitorius neutralizuojančios medžiagos ir jų naudojimo būdai
EA202091385A3 (ru) * 2014-08-20 2021-06-30 Портола Фармасьютикалз, Инк. Лиофилизированные составы для антидота фактора ха
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
EP4588932A3 (en) * 2016-06-17 2025-10-01 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
US20210196568A1 (en) * 2018-05-21 2021-07-01 Chugai Seiyaku Kabushiki Kaisha Lyophilized formulation sealed in glass container
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

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2151044A1 (en) 1992-12-15 1994-06-23 Terence K. Brunck Novel inhibitors for factor xa
CA2634663C (en) * 1999-02-22 2009-08-25 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
ES2254385T3 (es) 2000-02-29 2006-06-16 Millennium Pharmaceuticals, Inc. Benzamidas e inhibidores relacionados del factor xa.
US6586584B2 (en) * 2001-01-29 2003-07-01 Becton, Dickinson And Company Sequences and methods for detection of Hepatitis C virus
EP1589949B1 (en) * 2003-01-08 2008-08-13 Novartis Vaccines and Diagnostics, Inc. Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants
RU2440986C2 (ru) 2005-11-08 2012-01-27 Милленниум Фамэсьютикэлс, Инк. СОЛЬ ИНГИБИТОРА ФАКТОРА Ха, СПОСОБ ЕЕ ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ, СОСТОЯЩИЕ ИЗ НАЗВАННОЙ КОМПОЗИЦИИ ТАБЛЕТКА, КАПСУЛА И ЛЕПЕШКА, СПОСОБ ЛЕЧЕНИЯ ТРОМБОЗА И СПОСОБ ИНГИБИРОВАНИЯ КОАГУЛЯЦИИ ОБРАЗЦОВ КРОВИ
US9283260B2 (en) * 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
EP2193196B1 (en) * 2007-09-28 2016-07-13 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same
CN107050437A (zh) 2008-09-03 2017-08-18 奥克塔法马股份有限公司 重组制备的因子viii的新型保护组合物
EP2364165B1 (en) 2008-11-14 2018-01-03 Portola Pharmaceuticals, Inc. Antidotes for factor xa inhibitors and methods of using the same in combination with blood coagulating agents
LT3604510T (lt) * 2009-03-30 2025-07-10 Alexion Pharmaceuticals, Inc. Faktoriaus xa inhibitorius neutralizuojančios medžiagos ir jų naudojimo būdai
JP6163304B2 (ja) 2009-07-15 2017-07-12 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 第Xa因子インヒビターの解毒剤の単位用量処方物およびその使用方法
EP2458990B1 (en) * 2009-07-28 2016-03-30 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
CN103003422B (zh) * 2010-04-20 2015-02-11 奥克塔法马股份有限公司 用于药物蛋白的新型稳定剂
CN103339126B (zh) * 2010-12-03 2016-06-29 博尔托拉制药公司 式(i)化合物的固态形式及其药物组合物、剂型和使用方法
US9683020B2 (en) * 2011-08-01 2017-06-20 Emory University VLPS containing ligands and methods related thereto
US9371522B2 (en) * 2011-09-30 2016-06-21 The Children's Hospital Of Philadelphia Compositions and methods for modulating hemostasis
GB201310946D0 (en) * 2013-06-19 2013-07-31 Cambridge Entpr Ltd Antidote
EA202091385A3 (ru) 2014-08-20 2021-06-30 Портола Фармасьютикалз, Инк. Лиофилизированные составы для антидота фактора ха

Also Published As

Publication number Publication date
US20200299668A1 (en) 2020-09-24
KR102867491B1 (ko) 2025-10-01
SG11201701247RA (en) 2017-03-30
EP3182993B1 (en) 2020-07-01
CN107073082A (zh) 2017-08-18
JP7416549B2 (ja) 2024-01-17
WO2016029061A1 (en) 2016-02-25
US20160237420A1 (en) 2016-08-18
IL250413A0 (en) 2017-03-30
EA036091B1 (ru) 2020-09-25
KR20250150675A (ko) 2025-10-20
AU2020289768B2 (en) 2024-06-13
US20210284986A1 (en) 2021-09-16
EA202091385A3 (ru) 2021-06-30
CN113171447B (zh) 2024-05-17
KR20230007550A (ko) 2023-01-12
CA2961739C (en) 2024-04-30
US20180320160A1 (en) 2018-11-08
AU2015305413A1 (en) 2017-03-23
US11028382B2 (en) 2021-06-08
JP2017525704A (ja) 2017-09-07
AU2015305413B2 (en) 2020-09-24
JP6742986B2 (ja) 2020-08-19
EP3182993A4 (en) 2018-01-17
JP2019206595A (ja) 2019-12-05
EA201790415A1 (ru) 2017-08-31
IL276960A (en) 2020-10-29
DK3182993T3 (da) 2020-09-21
US20200299667A1 (en) 2020-09-24
CN113171447A (zh) 2021-07-27
EP3182993A1 (en) 2017-06-28
US20250163399A1 (en) 2025-05-22
IL276960B (en) 2022-04-01
CN107073082B (zh) 2021-04-30
KR102482517B1 (ko) 2022-12-28
AU2024219698A1 (en) 2024-10-03
JP2022003101A (ja) 2022-01-11
AU2020289768A1 (en) 2021-01-21
EP3750556A1 (en) 2020-12-16
ZA201701764B (en) 2020-10-28
KR20170042776A (ko) 2017-04-19
JP2023158199A (ja) 2023-10-26
CA2961739A1 (en) 2016-02-25
IL250413B (en) 2020-09-30
EA202091385A2 (ru) 2021-03-31

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