EA024267B1 - Стабилизированные жидкие и лиофилизированные композиции adamts13 - Google Patents

Стабилизированные жидкие и лиофилизированные композиции adamts13 Download PDF

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Publication number
EA024267B1
EA024267B1 EA201200519A EA201200519A EA024267B1 EA 024267 B1 EA024267 B1 EA 024267B1 EA 201200519 A EA201200519 A EA 201200519A EA 201200519 A EA201200519 A EA 201200519A EA 024267 B1 EA024267 B1 EA 024267B1
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EA
Eurasian Patent Office
Prior art keywords
composition
stabilized
preferred
activity
sugar
Prior art date
Application number
EA201200519A
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English (en)
Russian (ru)
Other versions
EA201200519A1 (ru
Inventor
Г. Петер Маттиссен
Петер Л. Турецек
Ханс-Петер Шварц
Original Assignee
Баксалта Инкорпорейтид
Баксалта Гмбх
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Application filed by Баксалта Инкорпорейтид, Баксалта Гмбх filed Critical Баксалта Инкорпорейтид
Publication of EA201200519A1 publication Critical patent/EA201200519A1/ru
Publication of EA024267B1 publication Critical patent/EA024267B1/ru

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    • 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)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/08Solutions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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)
    • C12Y304/24Metalloendopeptidases (3.4.24)
    • C12Y304/24087ADAMTS13 endopeptidase (3.4.24.87)
    • 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EA201200519A 2009-09-21 2010-09-21 Стабилизированные жидкие и лиофилизированные композиции adamts13 EA024267B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21
PCT/US2010/049723 WO2011035335A2 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations

Publications (2)

Publication Number Publication Date
EA201200519A1 EA201200519A1 (ru) 2012-09-28
EA024267B1 true EA024267B1 (ru) 2016-09-30

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EA201200519A EA024267B1 (ru) 2009-09-21 2010-09-21 Стабилизированные жидкие и лиофилизированные композиции adamts13

Country Status (21)

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US (9) US8623352B2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
EP (5) EP2480198B9 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
JP (2) JP5819303B2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
KR (6) KR20190137954A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
CN (2) CN104224705B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
AU (1) AU2010295299B2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
BR (1) BR112012006283B1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
CA (1) CA2774556A1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
DK (4) DK3167897T3 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
EA (1) EA024267B1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
ES (4) ES3001509T3 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
FI (2) FI4218797T3 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
FR (1) FR24C1049I1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
HR (1) HRP20160295T1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
HU (1) HUE028688T2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
IN (1) IN2012DN02645A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
MX (3) MX362382B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
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PL (4) PL2480198T3 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
PT (2) PT4218797T (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
WO (1) WO2011035335A2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)

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EP3311847A1 (en) * 2012-02-16 2018-04-25 Atyr Pharma, Inc. Histidyl-trna synthetases for treating autoimmune and inflammatory diseases
CN103566362B (zh) * 2012-07-21 2015-07-29 复旦大学 重组adamts13在制备脑出血药物中的用途
WO2014075033A2 (en) 2012-11-09 2014-05-15 Puget Sound Blood Center Protein stabilizing factors
WO2014145050A1 (en) 2013-03-15 2014-09-18 Atyr Pharma, Inc. Histidyl-trna synthetase-fc conjugates
AU2013203062C1 (en) * 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
EP4285930A3 (en) * 2014-06-26 2024-02-28 Amgen Inc. Protein formulations
GB201510870D0 (en) * 2015-05-26 2015-08-05 Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh Treatment of infarction
ES2983978T3 (es) * 2016-01-08 2024-10-28 Univ Kyoto Medicina que comprende ADAMTS13 como ingrediente principal
IL264372B2 (en) * 2016-08-04 2024-05-01 Baxalta Inc Use of ADAMTS13 for the treatment, improvement and/or prevention of vascular infarct crisis in sickle cell disease
EP4360652A3 (en) 2016-11-04 2024-06-26 Takeda Pharmaceutical Company Limited Adeno-associated virus formulations
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WO2019019998A1 (zh) * 2017-07-25 2019-01-31 江苏恒瑞医药股份有限公司 一种il-15蛋白复合物药物组合物及其用途
AU2019299964A1 (en) * 2018-07-11 2021-01-21 Takeda Pharmaceutical Company Limited AAV compositions
EP4037704A4 (en) 2019-10-04 2023-04-26 The Children's Medical Center Corporation Adamts13 treatment to enhance graft survival
CN115836126A (zh) 2020-04-02 2023-03-21 武田药品工业株式会社 Adamts13变体、组合物及其用途
JP2023526546A (ja) 2020-05-22 2023-06-21 武田薬品工業株式会社 コロナウイルス疾患の合併症の治療及び診断のための、adamts13組成物及び方法
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JP2025509154A (ja) 2022-03-08 2025-04-11 エクアシールド メディカル リミテッド ロボット医薬品調製システムにおける流体移送ステーション
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BR112012006283A2 (pt) 2016-05-31
JP5819303B2 (ja) 2015-11-24
US9937244B2 (en) 2018-04-10
DK4218797T5 (da) 2025-07-21
PL2480198T3 (pl) 2016-09-30
FI4218797T3 (fi) 2024-12-07
KR20180095738A (ko) 2018-08-27
ES3001509T3 (en) 2025-03-05
PT3834841T (pt) 2023-06-19
MX2019000547A (es) 2020-11-12
WO2011035335A3 (en) 2011-12-01
FR24C1049I1 (fr) 2025-01-17
CN102573792A (zh) 2012-07-11
EP4467160A3 (en) 2025-01-15
EP4467160A2 (en) 2024-11-27
EP2480198B9 (en) 2016-11-23
DK2480198T3 (en) 2016-03-29
US20170112906A1 (en) 2017-04-27
NZ598839A (en) 2014-03-28
JP2015063556A (ja) 2015-04-09
KR20250008986A (ko) 2025-01-16
PT4218797T (pt) 2024-12-09
EP2480198A2 (en) 2012-08-01
FI3834841T3 (fi) 2023-06-05
BR112012006283B1 (pt) 2022-03-15
KR20190137954A (ko) 2019-12-11
ES2579906T3 (es) 2016-08-17
KR20210054598A (ko) 2021-05-13
EP3834841A1 (en) 2021-06-16
JP2013505270A (ja) 2013-02-14
EP4218797A1 (en) 2023-08-02
EP4218797B1 (en) 2024-09-11
MX2012003414A (es) 2012-06-19
PL4218797T3 (pl) 2025-02-10
DK3834841T3 (da) 2023-06-06
US20190247475A1 (en) 2019-08-15
ES2865250T3 (es) 2021-10-15
US11564979B2 (en) 2023-01-31
US20110229455A1 (en) 2011-09-22
CA2774556A1 (en) 2011-03-24
EP3167897B1 (en) 2021-01-27
US20230130866A1 (en) 2023-04-27
US9572778B2 (en) 2017-02-21
KR20220139456A (ko) 2022-10-14
AU2010295299A1 (en) 2012-04-12
CN104224705A (zh) 2014-12-24
US8623352B2 (en) 2014-01-07
KR20120099646A (ko) 2012-09-11
MX362382B (es) 2019-01-14
PL3834841T3 (pl) 2023-07-24
EP3834841B1 (en) 2023-05-17
EA201200519A1 (ru) 2012-09-28
US9351935B2 (en) 2016-05-31
PL3167897T3 (pl) 2021-09-27
MX339205B (es) 2016-05-16
HRP20160295T1 (hr) 2016-05-20
US20160375111A1 (en) 2016-12-29
CN102573792B (zh) 2014-10-15
KR101891646B1 (ko) 2018-08-27
US20140178357A1 (en) 2014-06-26
US20180207245A1 (en) 2018-07-26
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HK1173968A1 (zh) 2013-05-31
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