DK3834841T3 - Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer - Google Patents

Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer Download PDF

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Publication number
DK3834841T3
DK3834841T3 DK20211228.0T DK20211228T DK3834841T3 DK 3834841 T3 DK3834841 T3 DK 3834841T3 DK 20211228 T DK20211228 T DK 20211228T DK 3834841 T3 DK3834841 T3 DK 3834841T3
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Denmark
Prior art keywords
stabilized liquid
adamts13 formulations
lyophilized adamts13
lyophilized
formulations
Prior art date
Application number
DK20211228.0T
Other languages
English (en)
Inventor
H Peter Matthiessen
Peter Turecek
Hans-Peter Schwarz
Original Assignee
Takeda Pharmaceuticals Co
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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Publication of DK3834841T3 publication Critical patent/DK3834841T3/da

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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
    • 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)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/08—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs 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
    • 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)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)
    • 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
    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (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)
DK20211228.0T 2009-09-21 2010-09-21 Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer DK3834841T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21
EP15203085.4A EP3167897B1 (en) 2009-09-21 2010-09-21 Stabilized liquid and lyophilized adamts13 formulations

Publications (1)

Publication Number Publication Date
DK3834841T3 true DK3834841T3 (da) 2023-06-06

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Application Number Title Priority Date Filing Date
DK15203085.4T DK3167897T3 (da) 2009-09-21 2010-09-21 Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK10759786.6T DK2480198T3 (da) 2009-09-21 2010-09-21 Stabiliserede væskeformige- og lyofiliserede adamts13-formuleringer
DK20211228.0T DK3834841T3 (da) 2009-09-21 2010-09-21 Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK23172759.5T DK4218797T5 (da) 2009-09-21 2010-09-21 Stabiliseret væske og frysetørrede adamts13-formuleringer

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DK15203085.4T DK3167897T3 (da) 2009-09-21 2010-09-21 Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK10759786.6T DK2480198T3 (da) 2009-09-21 2010-09-21 Stabiliserede væskeformige- og lyofiliserede adamts13-formuleringer

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DK23172759.5T DK4218797T5 (da) 2009-09-21 2010-09-21 Stabiliseret væske og frysetørrede adamts13-formuleringer

Country Status (21)

Country Link
US (9) US8623352B2 (da)
EP (5) EP4467160A3 (da)
JP (2) JP5819303B2 (da)
KR (6) KR20210054598A (da)
CN (2) CN102573792B (da)
AU (1) AU2010295299B2 (da)
BR (1) BR112012006283B1 (da)
CA (1) CA2774556A1 (da)
DK (4) DK3167897T3 (da)
EA (1) EA024267B1 (da)
ES (4) ES2865250T3 (da)
FI (2) FI3834841T3 (da)
FR (1) FR24C1049I2 (da)
HR (1) HRP20160295T1 (da)
HU (1) HUE028688T2 (da)
IN (1) IN2012DN02645A (da)
MX (3) MX339205B (da)
NZ (1) NZ598839A (da)
PL (4) PL3167897T3 (da)
PT (2) PT4218797T (da)
WO (1) WO2011035335A2 (da)

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CA2745805C (en) 2008-12-05 2021-01-19 Baxter International Inc. Methods of measuring adamts13-mediated in vivo cleavage of von willebrand factor and uses thereof
KR20210054598A (ko) * 2009-09-21 2021-05-13 다케다 야쿠힌 고교 가부시키가이샤 안정화된 액체 및 동결건조된 adamts13 제제
IN2014MN01642A (da) * 2012-02-16 2015-07-03 Atyr Pharma Inc
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
US10441531B2 (en) * 2012-11-09 2019-10-15 Bloodworks Protein stabilizing factors
AU2013203062C1 (en) * 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
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EA201990373A1 (ru) * 2016-08-04 2019-07-31 Баксалта Инкорпорэйтед Применение adamts13 для лечения, уменьшения интенсивности и/или предупреждения вазоокклюзивного криза при серповидноклеточной анемии, остром повреждении легкого и/или остром респираторном дистресс-синдроме
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Also Published As

Publication number Publication date
EP3167897B1 (en) 2021-01-27
EA201200519A1 (ru) 2012-09-28
EP3834841B1 (en) 2023-05-17
KR20190137954A (ko) 2019-12-11
PT3834841T (pt) 2023-06-19
BR112012006283A2 (pt) 2016-05-31
HUE028688T2 (en) 2017-01-30
EP4218797A1 (en) 2023-08-02
KR20180095738A (ko) 2018-08-27
EP4467160A2 (en) 2024-11-27
EP4218797B1 (en) 2024-09-11
FR24C1049I1 (fr) 2025-01-17
JP2013505270A (ja) 2013-02-14
KR20120099646A (ko) 2012-09-11
ES3001509T3 (en) 2025-03-05
WO2011035335A3 (en) 2011-12-01
PT4218797T (pt) 2024-12-09
US20170112906A1 (en) 2017-04-27
CN102573792B (zh) 2014-10-15
KR101891646B1 (ko) 2018-08-27
FI3834841T3 (fi) 2023-06-05
PL2480198T3 (pl) 2016-09-30
ES2948612T3 (es) 2023-09-14
HK1173968A1 (zh) 2013-05-31
US9937244B2 (en) 2018-04-10
US10238720B2 (en) 2019-03-26
PL3167897T3 (pl) 2021-09-27
ES2579906T3 (es) 2016-08-17
EP2480198B1 (en) 2016-03-09
US9351935B2 (en) 2016-05-31
US20230130866A1 (en) 2023-04-27
US9572778B2 (en) 2017-02-21
US20160375111A1 (en) 2016-12-29
CA2774556A1 (en) 2011-03-24
US11564979B2 (en) 2023-01-31
EP3167897A1 (en) 2017-05-17
NZ598839A (en) 2014-03-28
BR112012006283B1 (pt) 2022-03-15
MX2019000547A (es) 2020-11-12
EP2480198A2 (en) 2012-08-01
MX362382B (es) 2019-01-14
DK2480198T3 (da) 2016-03-29
PL3834841T3 (pl) 2023-07-24
CN102573792A (zh) 2012-07-11
CN104224705A (zh) 2014-12-24
DK4218797T3 (da) 2024-12-09
PL4218797T3 (pl) 2025-02-10
DK3167897T3 (da) 2021-04-19
EP3834841A1 (en) 2021-06-16
EP4218797B9 (en) 2025-04-30
US8623352B2 (en) 2014-01-07
JP5819303B2 (ja) 2015-11-24
US20190247475A1 (en) 2019-08-15
MX2012003414A (es) 2012-06-19
DK4218797T5 (da) 2025-07-21
US20110229455A1 (en) 2011-09-22
FI4218797T3 (fi) 2024-12-07
WO2011035335A2 (en) 2011-03-24
JP2015063556A (ja) 2015-04-09
US20180207245A1 (en) 2018-07-26
US10758599B2 (en) 2020-09-01
KR20210054598A (ko) 2021-05-13
US20200376098A1 (en) 2020-12-03
US20140178357A1 (en) 2014-06-26
CN104224705B (zh) 2018-02-02
ES2865250T3 (es) 2021-10-15
FR24C1049I2 (fr) 2025-12-12
IN2012DN02645A (da) 2015-09-11
EP4467160A3 (en) 2025-01-15
US12178861B2 (en) 2024-12-31
AU2010295299B2 (en) 2015-12-24
EP2480198B9 (en) 2016-11-23
AU2010295299A1 (en) 2012-04-12
KR20220139456A (ko) 2022-10-14
EA024267B1 (ru) 2016-09-30
HRP20160295T1 (hr) 2016-05-20
US20250099559A1 (en) 2025-03-27
KR20250008986A (ko) 2025-01-16
MX339205B (es) 2016-05-16

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