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
Other languages
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
Application filed by Formycon AG filed Critical Formycon AG
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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (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 (cg-RX-API-DMAC10.html)
EP (1) EP3407868A1 (cg-RX-API-DMAC10.html)
JP (1) JP6953433B2 (cg-RX-API-DMAC10.html)
AU (1) AU2017213103B2 (cg-RX-API-DMAC10.html)
CA (1) CA3011638C (cg-RX-API-DMAC10.html)
WO (1) WO2017129685A1 (cg-RX-API-DMAC10.html)

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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
EP3407868A1 (en) 2016-01-26 2018-12-05 Formycon AG Liquid formulation of a vegf antagonist
WO2018063963A1 (en) * 2016-09-28 2018-04-05 Board Of Regents, The University Of Texas System Antibody and protein therapeutic formulations and uses thereof
CN109937034B (zh) * 2016-11-21 2022-09-16 济世-伊沃泰克生物制品有限公司 阿柏西普制剂及其用途
CN114617999B (zh) 2017-03-27 2024-12-27 里珍纳龙药品有限公司 灭菌方法
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
WO2019099921A2 (en) * 2017-11-17 2019-05-23 Amgen Inc. Vegfr-fc fusion protein formulations
MY202872A (en) * 2017-11-20 2024-05-28 Just Evotec Biologics Inc Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
CN111699004A (zh) 2018-02-06 2020-09-22 豪夫迈·罗氏有限公司 眼科疾病的治疗
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora
WO2020047067A1 (en) * 2018-08-30 2020-03-05 Regeneron Pharmaceuticals, Inc. Methods for characterizing protein complexes
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
CN119033684A (zh) 2018-10-29 2024-11-29 豪夫迈·罗氏有限公司 抗体制剂
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
PE20240329A1 (es) 2019-06-05 2024-02-27 Regeneron Pharma Dispositivos y metodos para administracion de dosis de precision
IL309560B2 (en) 2019-12-06 2025-05-01 Regeneron Pharma Anti-VEGF protein preparations and methods for their production
JP7713950B2 (ja) * 2020-03-04 2025-07-28 上海復宏漢霖生物技術股▲フン▼有限公司 ベバシズマブを含む薬物製剤
MX2022013812A (es) 2020-05-08 2022-12-15 Regeneron Pharma Trampas y mini-trampas de vegf y metodos para el tratamiento de trastornos oculares y cancer.
EP4190310A4 (en) * 2020-07-31 2024-01-17 Celltrion, Inc. Stable pharmaceutical preparation
US12649031B2 (en) 2021-09-08 2026-06-09 Regeneron Pharmaceuticals, Inc. Methods for delivering agents with pre-filled syringes to minimize intraocular inflammation
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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WO2015173260A1 (en) 2014-05-12 2015-11-19 Formycon Ag Pre-filled plastic syringe containing a vegf antagonist
KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
US20180326126A1 (en) 2015-11-18 2018-11-15 Formycon Ag Pre-filled plastic syringe containing a vegf antagonist
EP3407868A1 (en) 2016-01-26 2018-12-05 Formycon AG Liquid formulation of a vegf antagonist

Also Published As

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

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