CA2805228C - A liquid formulation of long-acting human growth hormone conjugate - Google Patents

A liquid formulation of long-acting human growth hormone conjugate Download PDF

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Publication number
CA2805228C
CA2805228C CA2805228A CA2805228A CA2805228C CA 2805228 C CA2805228 C CA 2805228C CA 2805228 A CA2805228 A CA 2805228A CA 2805228 A CA2805228 A CA 2805228A CA 2805228 C CA2805228 C CA 2805228C
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CA
Canada
Prior art keywords
long
growth hormone
human growth
liquid formulation
acting
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.)
Expired - Fee Related
Application number
CA2805228A
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English (en)
French (fr)
Other versions
CA2805228A1 (en
Inventor
Sung Hee Hong
Byung Sun Lee
Dae Seong Im
Jae Min Lee
Sung Min Bae
Se Chang Kwon
Original Assignee
Hanmi Science Co Ltd
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Application filed by Hanmi Science Co Ltd filed Critical Hanmi Science Co Ltd
Publication of CA2805228A1 publication Critical patent/CA2805228A1/en
Application granted granted Critical
Publication of CA2805228C publication Critical patent/CA2805228C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2805228A 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate Expired - Fee Related CA2805228C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2010-0067796 2010-07-14
KR1020100067796A KR101337797B1 (ko) 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제
PCT/KR2011/005194 WO2012008779A2 (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate

Publications (2)

Publication Number Publication Date
CA2805228A1 CA2805228A1 (en) 2012-01-19
CA2805228C true CA2805228C (en) 2019-05-07

Family

ID=45469941

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2805228A Expired - Fee Related CA2805228C (en) 2010-07-14 2011-07-14 A liquid formulation of long-acting human growth hormone conjugate

Country Status (13)

Country Link
US (1) US9061072B2 (https=)
EP (1) EP2593084B1 (https=)
JP (1) JP5946448B2 (https=)
KR (1) KR101337797B1 (https=)
AR (2) AR082223A1 (https=)
AU (1) AU2011277203B2 (https=)
BR (1) BR112013000902A2 (https=)
CA (1) CA2805228C (https=)
ES (1) ES2673022T3 (https=)
IL (1) IL224225B (https=)
RU (1) RU2623026C2 (https=)
TW (1) TWI459961B (https=)
WO (1) WO2012008779A2 (https=)

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KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
AR092862A1 (es) 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
WO2014073842A1 (en) 2012-11-06 2014-05-15 Hanmi Pharm. Co., Ltd. Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment
US20160017017A1 (en) 2013-03-11 2016-01-21 Novo Nordisk Healthcare Ag Growth Hormone Compounds
CN105229035A (zh) * 2013-03-11 2016-01-06 诺和诺德保健股份有限公司 生长激素化合物
WO2014144549A1 (en) 2013-03-15 2014-09-18 Biogen Idec Ma Inc. Factor ix polypeptide formulations
AR096890A1 (es) * 2013-07-12 2016-02-03 Hanmi Pharm Ind Co Ltd Conjugando fc de inmunoglobulina, que mantiene la afinidad de unión del fragmento fc de la inmunoglobulina a fcrn
EP3689335A1 (en) 2013-09-27 2020-08-05 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation
MX387560B (es) * 2014-03-31 2025-03-18 Hanmi Pharmaceutical Co Ltd Procedimiento para mejorar la solubilidad de proteínas y péptidos usando un enlace del fragmento fc de inmunoglobulina.
TWI802396B (zh) 2014-09-16 2023-05-11 南韓商韓美藥品股份有限公司 長效glp-1/高血糖素受體雙促效劑治療非酒精性脂肝疾病之用途
EP3230309B1 (en) * 2014-12-10 2023-03-29 OPKO Biologics Ltd. Methods of producing long acting ctp-modified growth hormone polypeptides
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체
US9744239B2 (en) 2015-01-30 2017-08-29 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9937223B2 (en) 2015-01-30 2018-04-10 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9925233B2 (en) 2015-01-30 2018-03-27 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9687526B2 (en) 2015-01-30 2017-06-27 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
US9744209B2 (en) 2015-01-30 2017-08-29 Par Pharmaceutical, Inc. Vasopressin formulations for use in treatment of hypotension
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ES2784603T3 (es) 2015-06-02 2020-09-29 Novo Nordisk As Insulinas con extensiones recombinantes polares
DK3347403T3 (da) 2015-09-11 2020-06-29 Dow Global Technologies Llc Polyalkoxyfedtforbindelse
DK3347031T3 (da) 2015-09-11 2021-04-26 Nutrition & Biosciences Usa 1 Llc Sammensætning, der omfatter et protein og en polyalkoxyfedtforbindelse
TW202446416A (zh) * 2015-09-24 2024-12-01 美商拜奧馬林製藥公司 腺相關病毒因子viii載體、相關病毒粒子及包含其之治療調配物
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Also Published As

Publication number Publication date
EP2593084B1 (en) 2018-03-14
EP2593084A2 (en) 2013-05-22
KR101337797B1 (ko) 2013-12-06
US9061072B2 (en) 2015-06-23
RU2013106276A (ru) 2014-08-20
TWI459961B (zh) 2014-11-11
AR113034A2 (es) 2020-01-22
AU2011277203B2 (en) 2015-11-12
CN103068366A (zh) 2013-04-24
IL224225B (en) 2018-07-31
WO2012008779A3 (en) 2012-05-24
ES2673022T3 (es) 2018-06-19
AU2011277203A1 (en) 2013-02-28
RU2623026C2 (ru) 2017-06-21
AR082223A1 (es) 2012-11-21
CA2805228A1 (en) 2012-01-19
TW201215404A (en) 2012-04-16
BR112013000902A2 (pt) 2020-08-25
EP2593084A4 (en) 2014-11-05
US20130115231A1 (en) 2013-05-09
JP5946448B2 (ja) 2016-07-06
WO2012008779A2 (en) 2012-01-19
JP2013531034A (ja) 2013-08-01
KR20120007182A (ko) 2012-01-20

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