CA3011638C - Liquid formulation of a vegf antagonist - Google Patents

Liquid formulation of a vegf antagonist Download PDF

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Publication number
CA3011638C
CA3011638C CA3011638A CA3011638A CA3011638C CA 3011638 C CA3011638 C CA 3011638C CA 3011638 A CA3011638 A CA 3011638A CA 3011638 A CA3011638 A CA 3011638A CA 3011638 C CA3011638 C CA 3011638C
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CA
Canada
Prior art keywords
histidine
aflibercept
concentration
polysorbate
vegf
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
CA3011638A
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English (en)
French (fr)
Other versions
CA3011638A1 (en
Inventor
Rainer Sigl
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.)
Formycon AG
Original Assignee
Formycon 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
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Publication of CA3011638A1 publication Critical patent/CA3011638A1/en
Application granted granted Critical
Publication of CA3011638C publication Critical patent/CA3011638C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K47/22—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
    • A61K9/0012—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts or implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
    • 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
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA3011638A 2016-01-26 2017-01-26 Liquid formulation of a vegf antagonist Active CA3011638C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP16152767 2016-01-26
EP16152767.6 2016-01-26
EP16199497.5 2016-11-18
EP16199497 2016-11-18
PCT/EP2017/051662 WO2017129685A1 (en) 2016-01-26 2017-01-26 Liquid formulation of a vegf antagonist

Publications (2)

Publication Number Publication Date
CA3011638A1 CA3011638A1 (en) 2017-08-03
CA3011638C true CA3011638C (en) 2023-01-10

Family

ID=57882094

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3011638A Active CA3011638C (en) 2016-01-26 2017-01-26 Liquid formulation of a vegf antagonist

Country Status (6)

Country Link
US (3) US10576128B2 (https=)
EP (1) EP3407868A1 (https=)
JP (1) JP6953433B2 (https=)
AU (1) AU2017213103B2 (https=)
CA (1) CA3011638C (https=)
WO (1) WO2017129685A1 (https=)

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CA2654510C (en) 2006-06-16 2015-03-17 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist
EP3518971A4 (en) * 2016-09-28 2020-05-13 Board Of Regents, The University Of Texas System ANTIBODIES AND THERAPEUTIC PROTEIN FORMULATIONS AND USES THEREOF
JP7116059B2 (ja) * 2016-11-21 2022-08-09 ジャスト－エヴォテック バイオロジックス、インコーポレイテッド アフリベルセプト製剤及びその使用
FI3600456T3 (fi) 2017-03-27 2023-10-26 Regeneron Pharma Sterilointimenetelmä
WO2019020777A1 (en) 2017-07-26 2019-01-31 Formycon Ag LIQUID FORMULATION OF A VEGF ANTAGONIST
US20200255496A1 (en) 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations
MX2020005170A (es) * 2017-11-17 2020-10-16 Amgen Inc Formulaciones de proteinas de fusion vegfr-fc.
MY202872A (en) * 2017-11-20 2024-05-28 Just Evotec Biologics Inc Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
DK4364724T3 (da) * 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
JP7511542B2 (ja) * 2018-08-30 2024-07-05 リジェネロン・ファーマシューティカルズ・インコーポレイテッド タンパク質複合体を特徴づけるための方法
WO2020055123A1 (ko) * 2018-09-10 2020-03-19 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
US20210353713A1 (en) 2018-10-26 2021-11-18 Amgen Inc. Formulations comprising a tris buffer and a protein
MY195550A (en) * 2018-10-29 2023-01-31 Hoffmann La Roche Antibody Formulation
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
EP3886946A1 (en) 2019-06-05 2021-10-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
SG11202110968VA (en) 2019-12-06 2021-10-28 Regeneron Pharma Anti-vegf protein compositions and methods for producing the same
IL296119A (en) * 2020-03-04 2022-11-01 Shanghai Henlius Biotech Inc Pharmaceutical formulation comprising bevacizumab
AU2021268026A1 (en) 2020-05-08 2023-01-19 Regeneron Pharmaceuticals, Inc. VEGF traps and mini-traps and methods for treating ocular disorders and cancer
CA3190325A1 (en) * 2020-07-31 2022-02-03 Celltrion Inc. Stable pharmaceutical preparation
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
USD1120314S1 (en) 2022-11-30 2026-03-24 Regeneron Pharmaceuticals, Inc. Dose delivery device
WO2025217334A1 (en) * 2024-04-09 2025-10-16 Regeneron Pharmaceuticals, Inc. Low concentration vegf receptor fusion protein containing formulations

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US6582959B2 (en) 1991-03-29 2003-06-24 Genentech, Inc. Antibodies to vascular endothelial cell growth factor
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IL117645A (en) 1995-03-30 2005-08-31 Genentech Inc Vascular endothelial cell growth factor antagonists for use as medicaments in the treatment of age-related macular degeneration
JP4531132B2 (ja) 1995-06-02 2010-08-25 ギリード・サイエンシズ・インコーポレーテッド 増殖因子に対する高親和性オリゴヌクレオチドリガンド
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KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
CN108290004A (zh) 2015-11-18 2018-07-17 福尔密孔股份公司 含有vegf拮抗剂的预填充塑料注射器
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist

Also Published As

Publication number Publication date
AU2017213103B2 (en) 2022-08-11
US12551529B2 (en) 2026-02-17
JP6953433B2 (ja) 2021-10-27
US20230248806A1 (en) 2023-08-10
JP2019504882A (ja) 2019-02-21
US20190030123A1 (en) 2019-01-31
US20200237862A1 (en) 2020-07-30
AU2017213103A1 (en) 2018-07-26
EP3407868A1 (en) 2018-12-05
CA3011638A1 (en) 2017-08-03
WO2017129685A1 (en) 2017-08-03
US10576128B2 (en) 2020-03-03

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