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EA033373B1 - Композиции на водной основе, предварительно наполненный шприц, их применения и способ доставки гипофукозилированного или нефукозилированного антитела против baffr млекопитающему - Google Patents

Композиции на водной основе, предварительно наполненный шприц, их применения и способ доставки гипофукозилированного или нефукозилированного антитела против baffr млекопитающему

Info

Publication number
EA033373B1
EA033373B1 EA201492292A EA201492292A EA033373B1 EA 033373 B1 EA033373 B1 EA 033373B1 EA 201492292 A EA201492292 A EA 201492292A EA 201492292 A EA201492292 A EA 201492292A EA 033373 B1 EA033373 B1 EA 033373B1
Authority
EA
Eurasian Patent Office
Prior art keywords
mammal
water
based compositions
filled syringe
preliminally
Prior art date
Application number
EA201492292A
Other languages
English (en)
Other versions
EA201492292A1 (ru
Inventor
Marta Cosenza
Christoph Stark
Original Assignee
Novartis Ag
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 date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48914378&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA033373(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of EA201492292A1 publication Critical patent/EA201492292A1/ru
Publication of EA033373B1 publication Critical patent/EA033373B1/ru

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/26—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
    • A61K9/0012—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Oncology (AREA)
  • Rheumatology (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Изобретение относится к композициям на водной основе с pH 5,5-6,5, которые содержат гипофукозилированное или нефукозилированное антитело против BAFFR, сахарозу, гистидин, полисорбат 20 и аргинин в различных концентрациях. Кроме того, предложены предварительно наполненный шприц, включающий указанную композицию, и способ доставки гипофукозилированного или нефукозилированного антитела против BAFFR млекопитающему, включающий стадию введения млекопитающему такой композиции. Также представлены применения композиции или предварительно наполненного шприца для лечения заболевания или нарушения, которое опосредуется рецептором BAFF или лечение которого можно осуществлять посредством уничтожения или истощения В-клеток.
EA201492292A 2012-06-12 2013-06-11 Композиции на водной основе, предварительно наполненный шприц, их применения и способ доставки гипофукозилированного или нефукозилированного антитела против baffr млекопитающему EA033373B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261658472P 2012-06-12 2012-06-12
PCT/IB2013/054777 WO2013186700A1 (en) 2012-06-12 2013-06-11 Antibody formulation

Publications (2)

Publication Number Publication Date
EA201492292A1 EA201492292A1 (ru) 2015-04-30
EA033373B1 true EA033373B1 (ru) 2019-10-31

Family

ID=48914378

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201492292A EA033373B1 (ru) 2012-06-12 2013-06-11 Композиции на водной основе, предварительно наполненный шприц, их применения и способ доставки гипофукозилированного или нефукозилированного антитела против baffr млекопитающему

Country Status (35)

Country Link
US (4) US9216219B2 (ru)
EP (2) EP3593814B1 (ru)
JP (1) JP6265978B2 (ru)
KR (1) KR102124820B1 (ru)
CN (1) CN104363920B (ru)
AR (1) AR091413A1 (ru)
AU (1) AU2013276112B2 (ru)
BR (1) BR112014030820B1 (ru)
CA (1) CA2875386C (ru)
CL (1) CL2014003370A1 (ru)
CO (1) CO7151487A2 (ru)
CY (1) CY1122181T1 (ru)
DK (1) DK2858671T3 (ru)
EA (1) EA033373B1 (ru)
EC (1) ECSP15017314A (ru)
ES (1) ES2751659T3 (ru)
GT (1) GT201400285A (ru)
HR (1) HRP20191827T1 (ru)
HU (1) HUE045523T2 (ru)
IL (1) IL235966B (ru)
LT (1) LT2858671T (ru)
MA (1) MA37616A1 (ru)
MX (1) MX363380B (ru)
MY (1) MY179818A (ru)
NZ (1) NZ630885A (ru)
PE (1) PE20150200A1 (ru)
PH (1) PH12014502778A1 (ru)
PL (1) PL2858671T3 (ru)
PT (1) PT2858671T (ru)
SG (1) SG11201408174UA (ru)
SI (1) SI2858671T1 (ru)
TN (1) TN2014000488A1 (ru)
TW (1) TWI653983B (ru)
WO (1) WO2013186700A1 (ru)
ZA (1) ZA201408547B (ru)

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