IL291556B2 - Methods and compositions for administration of arylsulfatase A to the central nervous system - Google Patents

Methods and compositions for administration of arylsulfatase A to the central nervous system

Info

Publication number
IL291556B2
IL291556B2 IL291556A IL29155622A IL291556B2 IL 291556 B2 IL291556 B2 IL 291556B2 IL 291556 A IL291556 A IL 291556A IL 29155622 A IL29155622 A IL 29155622A IL 291556 B2 IL291556 B2 IL 291556B2
Authority
IL
Israel
Prior art keywords
formulation
approximately
polysorbate
concentration
following
Prior art date
Application number
IL291556A
Other languages
English (en)
Hebrew (he)
Other versions
IL291556B1 (en
IL291556A (en
Original Assignee
Shire Human Genetic Therapies
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.)
Filing date
Publication date
Application filed by Shire Human Genetic Therapies, Takeda Pharmaceuticals Co filed Critical Shire Human Genetic Therapies
Publication of IL291556A publication Critical patent/IL291556A/en
Publication of IL291556B1 publication Critical patent/IL291556B1/en
Publication of IL291556B2 publication Critical patent/IL291556B2/en

Links

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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • 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)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • 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)
    • 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
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • 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
    • 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
    • A61K47/26—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
    • A61K9/14—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Psychology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
IL291556A 2010-06-25 2011-06-25 Methods and compositions for administration of arylsulfatase A to the central nervous system IL291556B2 (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US35885710P 2010-06-25 2010-06-25
US36078610P 2010-07-01 2010-07-01
US38786210P 2010-09-29 2010-09-29
US201161435710P 2011-01-24 2011-01-24
US201161442115P 2011-02-11 2011-02-11
US201161476210P 2011-04-15 2011-04-15
US201161495268P 2011-06-09 2011-06-09
PCT/US2011/041926 WO2011163650A2 (en) 2010-06-25 2011-06-25 Methods and compositions for cns delivery of arylsulfatase a

Publications (3)

Publication Number Publication Date
IL291556A IL291556A (en) 2022-05-01
IL291556B1 IL291556B1 (en) 2023-10-01
IL291556B2 true IL291556B2 (en) 2024-02-01

Family

ID=46888844

Family Applications (3)

Application Number Title Priority Date Filing Date
IL291556A IL291556B2 (en) 2010-06-25 2011-06-25 Methods and compositions for administration of arylsulfatase A to the central nervous system
IL223758A IL223758B (en) 2010-06-25 2012-12-20 Methods and preparations for administration of arylsulfatase a to the central nervous system
IL273854A IL273854B (en) 2010-06-25 2020-04-06 Methods and preparations for administration of arylsulfatase a to the central nervous system

Family Applications After (2)

Application Number Title Priority Date Filing Date
IL223758A IL223758B (en) 2010-06-25 2012-12-20 Methods and preparations for administration of arylsulfatase a to the central nervous system
IL273854A IL273854B (en) 2010-06-25 2020-04-06 Methods and preparations for administration of arylsulfatase a to the central nervous system

Country Status (26)

Country Link
US (1) US9770410B2 (https=)
EP (3) EP3964230A1 (https=)
JP (1) JP6045493B2 (https=)
KR (5) KR102537084B1 (https=)
CN (1) CN103282046B (https=)
AU (5) AU2011270670B2 (https=)
BR (1) BR112012033216B1 (https=)
CA (1) CA2803003C (https=)
CY (2) CY1122282T1 (https=)
DK (1) DK2585104T3 (https=)
ES (1) ES2754776T3 (https=)
HR (1) HRP20191923T1 (https=)
IL (3) IL291556B2 (https=)
LT (1) LT2585104T (https=)
ME (1) ME03647B (https=)
MX (2) MX344795B (https=)
NZ (2) NZ605873A (https=)
PL (2) PL3626257T3 (https=)
RS (1) RS59468B1 (https=)
RU (1) RU2671503C2 (https=)
SI (1) SI2585104T1 (https=)
SM (1) SMT201900589T1 (https=)
TW (1) TWI667037B (https=)
UA (1) UA115650C2 (https=)
WO (1) WO2011163650A2 (https=)
ZA (1) ZA201300675B (https=)

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RS62620B1 (sr) 2010-06-25 2021-12-31 Shire Human Genetic Therapies Metode i kompozicije za isporuku cns akrilsulfataze a
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WO2020004368A1 (ja) * 2018-06-25 2020-01-02 Ｊｃｒファーマ株式会社 蛋白質含有水性液剤
BR112021021908A2 (pt) * 2019-05-03 2022-02-01 Univ Pennsylvania Composições úteis no tratamento da leucodistrofia metacromática
WO2021061517A1 (en) * 2019-09-23 2021-04-01 University Of Washington Assay of arylsulfatase a enzymatic activity in dried blood spots by mass spectrometry and fluorometry
WO2024176112A1 (en) 2023-02-21 2024-08-29 Takeda Pharmaceutical Company Limited Large scale production of recombinant arylsulfatase a and compositions thereof

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Also Published As

Publication number Publication date
CA2803003A1 (en) 2011-12-29
ME03647B (me) 2020-07-20
HRP20191923T1 (hr) 2020-01-10
CY1122282T1 (el) 2020-11-25
UA115650C2 (uk) 2017-12-11
KR20200035167A (ko) 2020-04-01
MX344795B (es) 2017-01-05
KR20180059580A (ko) 2018-06-04
IL291556B1 (en) 2023-10-01
AU2021236557B2 (en) 2025-01-30
NZ605873A (en) 2015-02-27
SMT201900589T1 (it) 2020-03-13
KR101997935B1 (ko) 2019-10-04
AU2025202376A1 (en) 2025-04-24
LT2585104T (lt) 2019-10-25
JP2013538788A (ja) 2013-10-17
PL3626257T3 (pl) 2022-03-28
MX2013000323A (es) 2013-06-05
EP2585104A2 (en) 2013-05-01
EP3626257B1 (en) 2021-08-04
NZ702799A (en) 2016-08-26
US20120009171A1 (en) 2012-01-12
TW201206464A (en) 2012-02-16
TWI667037B (zh) 2019-08-01
AU2011270670A1 (en) 2013-02-14
PL2585104T3 (pl) 2020-01-31
CA2803003C (en) 2022-11-22
CY1124910T1 (el) 2023-01-05
DK2585104T3 (da) 2019-10-14
EP2585104A4 (en) 2014-01-15
KR20230079472A (ko) 2023-06-07
CN103282046B (zh) 2015-05-13
BR112012033216B1 (pt) 2022-10-11
RU2012154574A (ru) 2014-07-27
KR20130135821A (ko) 2013-12-11
KR102094094B1 (ko) 2020-03-27
CN103282046A (zh) 2013-09-04
ES2754776T3 (es) 2020-04-20
AU2019204051A1 (en) 2019-08-29
WO2011163650A3 (en) 2013-06-13
US9770410B2 (en) 2017-09-26
EP3626257A1 (en) 2020-03-25
IL273854B (en) 2022-04-01
WO2011163650A2 (en) 2011-12-29
KR20210131449A (ko) 2021-11-02
AU2019204051B2 (en) 2021-07-22
EP2585104B1 (en) 2019-08-21
RU2671503C2 (ru) 2018-11-01
SI2585104T1 (sl) 2019-11-29
IL291556A (en) 2022-05-01
KR102537084B1 (ko) 2023-05-26
IL273854A (en) 2020-05-31
AU2021236557A1 (en) 2021-10-28
JP6045493B2 (ja) 2016-12-14
MX382443B (es) 2025-03-11
AU2011270670B2 (en) 2017-01-12
KR102318997B1 (ko) 2021-10-29
AU2017202289B2 (en) 2019-03-14
RS59468B1 (sr) 2019-11-29
BR112012033216A2 (pt) 2020-08-25
KR102720061B1 (ko) 2024-10-22
IL223758B (en) 2020-04-30
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EP3964230A1 (en) 2022-03-09
ZA201300675B (en) 2017-11-29

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