DK3436053T3 - Formuleringer, som omfatter rekombinant syre-alfa-glucosidase - Google Patents

Formuleringer, som omfatter rekombinant syre-alfa-glucosidase Download PDF

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Publication number
DK3436053T3
DK3436053T3 DK17719388.5T DK17719388T DK3436053T3 DK 3436053 T3 DK3436053 T3 DK 3436053T3 DK 17719388 T DK17719388 T DK 17719388T DK 3436053 T3 DK3436053 T3 DK 3436053T3
Authority
DK
Denmark
Prior art keywords
glucosidase
formulations
acid alpha
recombinant acid
recombinant
Prior art date
Application number
DK17719388.5T
Other languages
English (en)
Inventor
Hing Char
Sergey Tesler
Wendy Sunderland
Enrique Diloné
Russell Gotschall
Hung Do
Original Assignee
Amicus Therapeutics Inc
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 Amicus Therapeutics Inc filed Critical Amicus Therapeutics Inc
Priority claimed from PCT/US2017/024982 external-priority patent/WO2017173060A1/en
Application granted granted Critical
Publication of DK3436053T3 publication Critical patent/DK3436053T3/da

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Classifications

    • 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)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K47/26Carbohydrates, 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
    • A61K9/14Particulate 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
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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)
    • C12N9/24Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2405Glucanases
    • C12N9/2408Glucanases acting on alpha -1,4-glucosidic bonds
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/0102Alpha-glucosidase (3.2.1.20)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
DK17719388.5T 2016-03-30 2017-03-30 Formuleringer, som omfatter rekombinant syre-alfa-glucosidase DK3436053T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662315436P 2016-03-30 2016-03-30
US201762457588P 2017-02-10 2017-02-10
PCT/US2017/024982 WO2017173060A1 (en) 2016-03-30 2017-03-30 Formulations comprising recombinant acid alpha-glucosidase

Publications (1)

Publication Number Publication Date
DK3436053T3 true DK3436053T3 (da) 2022-07-11

Family

ID=61021858

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17719388.5T DK3436053T3 (da) 2016-03-30 2017-03-30 Formuleringer, som omfatter rekombinant syre-alfa-glucosidase

Country Status (12)

Country Link
EP (2) EP3436053B1 (da)
CN (2) CN114712490A (da)
DK (1) DK3436053T3 (da)
ES (1) ES2921673T3 (da)
HR (1) HRP20220817T1 (da)
HU (1) HUE059014T2 (da)
LT (1) LT3436053T (da)
PL (1) PL3436053T3 (da)
PT (1) PT3436053T (da)
RS (1) RS63362B1 (da)
SI (1) SI3436053T1 (da)
TW (4) TWI820564B (da)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020073438A1 (en) * 1995-08-02 2002-06-13 Reuser Arnold J. Methods of purifying human acid alpha-glucosidase
CN101636200A (zh) * 2006-11-13 2010-01-27 齐斯特治疗公司 用于治疗庞贝氏症的方法
WO2009102895A2 (en) 2008-02-12 2009-08-20 Amicus Therapeutics, Inc. Method to predict response to pharmacological chaperone treatment of diseases
EP3679942A1 (en) * 2009-06-17 2020-07-15 BioMarin Pharmaceutical Inc. Formulations for lysosomal enzymes
WO2013013017A2 (en) * 2011-07-21 2013-01-24 Alnylam Pharmaceuticals, Inc. Compositions and methods for modifying the glycosylation of lysosomal storage disorder therapeutics
KR20230066482A (ko) * 2012-03-07 2023-05-15 아미쿠스 세라퓨틱스, 인코포레이티드 폼페병의 치료를 위한 고농도 알파-글루코시다제 조성물

Also Published As

Publication number Publication date
CN114712490A (zh) 2022-07-08
TW201733614A (zh) 2017-10-01
PT3436053T (pt) 2022-07-08
HUE059014T2 (hu) 2022-09-28
EP3436053A1 (en) 2019-02-06
EP4098274A1 (en) 2022-12-07
RS63362B1 (sr) 2022-07-29
CN109475607A (zh) 2019-03-15
ES2921673T3 (es) 2022-08-30
HRP20220817T1 (hr) 2022-09-30
SI3436053T1 (sl) 2022-08-31
CN109475607B (zh) 2022-04-26
EP3436053B1 (en) 2022-04-06
LT3436053T (lt) 2022-07-11
TWI774670B (zh) 2022-08-21
TW202231296A (zh) 2022-08-16
TWI813388B (zh) 2023-08-21
PL3436053T3 (pl) 2022-08-01
TWI820564B (zh) 2023-11-01
TW202245832A (zh) 2022-12-01
TW202402323A (zh) 2024-01-16

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