AU2020373017B2 - Crizanlizumab containing antibody formulation - Google Patents

Crizanlizumab containing antibody formulation Download PDF

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Publication number
AU2020373017B2
AU2020373017B2 AU2020373017A AU2020373017A AU2020373017B2 AU 2020373017 B2 AU2020373017 B2 AU 2020373017B2 AU 2020373017 A AU2020373017 A AU 2020373017A AU 2020373017 A AU2020373017 A AU 2020373017A AU 2020373017 B2 AU2020373017 B2 AU 2020373017B2
Authority
AU
Australia
Prior art keywords
pharmaceutical composition
crizanlizumab
sucrose
phosphate
months
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2020373017A
Other languages
English (en)
Other versions
AU2020373017A1 (en
Inventor
Maja ANKO
Fabian BICKEL
Lina Maria Boado CHAVES
Dirk Chelius
Francois GRIAUD
Caroline HILBERT
Aljosa JELENKO
Frieder KROENER
Rajsekhar PAUL
Juergen Sigg
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
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.)
Filing date
Publication date
Application filed by Novartis AG filed Critical Novartis AG
Publication of AU2020373017A1 publication Critical patent/AU2020373017A1/en
Application granted granted Critical
Publication of AU2020373017B2 publication Critical patent/AU2020373017B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
AU2020373017A 2019-10-30 2020-10-29 Crizanlizumab containing antibody formulation Active AU2020373017B2 (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962927720P 2019-10-30 2019-10-30
US201962927716P 2019-10-30 2019-10-30
US62/927,716 2019-10-30
US62/927,720 2019-10-30
US201962933692P 2019-11-11 2019-11-11
US62/933,692 2019-11-11
US201962936269P 2019-11-15 2019-11-15
US62/936,269 2019-11-15
PCT/US2020/057868 WO2021087050A1 (en) 2019-10-30 2020-10-29 Crizanlizumab containing antibody formulation

Publications (2)

Publication Number Publication Date
AU2020373017A1 AU2020373017A1 (en) 2022-05-19
AU2020373017B2 true AU2020373017B2 (en) 2024-06-06

Family

ID=73544317

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020373017A Active AU2020373017B2 (en) 2019-10-30 2020-10-29 Crizanlizumab containing antibody formulation

Country Status (19)

Country Link
US (1) US20220378912A1 (enExample)
EP (1) EP4051236A1 (enExample)
JP (1) JP2023501155A (enExample)
KR (1) KR20220092917A (enExample)
CN (1) CN114828826A (enExample)
AU (1) AU2020373017B2 (enExample)
BR (1) BR112022008097A2 (enExample)
CA (1) CA3158921A1 (enExample)
CL (1) CL2022001085A1 (enExample)
CO (1) CO2022005207A2 (enExample)
EC (1) ECSP22033601A (enExample)
IL (1) IL292403A (enExample)
JO (1) JOP20220097A1 (enExample)
MX (1) MX2022005044A (enExample)
MY (1) MY209141A (enExample)
PE (1) PE20221276A1 (enExample)
PH (1) PH12022551041A1 (enExample)
TW (1) TWI893018B (enExample)
WO (1) WO2021087050A1 (enExample)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018083645A1 (en) * 2016-11-03 2018-05-11 Novartis Ag Treatment regimens
WO2018211517A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE041957T2 (hu) 2006-12-01 2019-06-28 Novartis Ag Anti-P-szelektin antitestek és eljárások azok alkalmazására gyulladásos betegségek kezelésére
CA3092931A1 (en) * 2018-03-08 2019-09-12 Novartis Ag Use of an anti-p-selectin antibody

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018083645A1 (en) * 2016-11-03 2018-05-11 Novartis Ag Treatment regimens
WO2018211517A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity

Also Published As

Publication number Publication date
IL292403A (en) 2022-06-01
TW202128221A (zh) 2021-08-01
WO2021087050A1 (en) 2021-05-06
CN114828826A (zh) 2022-07-29
MX2022005044A (es) 2022-05-16
ECSP22033601A (es) 2022-05-31
CA3158921A1 (en) 2021-05-06
PH12022551041A1 (en) 2023-04-24
CO2022005207A2 (es) 2022-05-10
BR112022008097A2 (pt) 2022-08-02
KR20220092917A (ko) 2022-07-04
JOP20220097A1 (ar) 2023-01-30
EP4051236A1 (en) 2022-09-07
JP2023501155A (ja) 2023-01-18
US20220378912A1 (en) 2022-12-01
CL2022001085A1 (es) 2023-02-03
AU2020373017A1 (en) 2022-05-19
MY209141A (en) 2025-06-24
TWI893018B (zh) 2025-08-11
PE20221276A1 (es) 2022-09-05

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Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ BICKEL, FABIAN; CHAVES, LINA MARIA BOADO; CHELIUS, DIRK; GRIAUD, FRANCOIS; HILBERT, CAROLINE; KROENER, FRIEDER; SIGG, JUERGEN; PAUL, RAJSEKHAR; ANKO, MAJA AND JELENKO, ALJOSA

FGA Letters patent sealed or granted (standard patent)