DK4019039T3 - Sammensætninger i form af en injicerbar vandig opløsning, som omfatter mindst et humant insulin A21G og en glucagonundertrykker med prandial virkning - Google Patents

Sammensætninger i form af en injicerbar vandig opløsning, som omfatter mindst et humant insulin A21G og en glucagonundertrykker med prandial virkning Download PDF

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Publication number
DK4019039T3
DK4019039T3 DK22156880.1T DK22156880T DK4019039T3 DK 4019039 T3 DK4019039 T3 DK 4019039T3 DK 22156880 T DK22156880 T DK 22156880T DK 4019039 T3 DK4019039 T3 DK 4019039T3
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DK
Denmark
Prior art keywords
compositions
aqueous solution
human insulin
injectable aqueous
prandial action
Prior art date
Application number
DK22156880.1T
Other languages
English (en)
Inventor
You-Ping Chan
Original Assignee
Adocia
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
Priority claimed from FR1757172A external-priority patent/FR3069436A1/fr
Priority claimed from FR1757184A external-priority patent/FR3069437A1/fr
Priority claimed from FR1855250A external-priority patent/FR3082426A1/fr
Application filed by Adocia filed Critical Adocia
Application granted granted Critical
Publication of DK4019039T3 publication Critical patent/DK4019039T3/da

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    • 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
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • 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
    • 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
    • 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
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/62Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
DK22156880.1T 2017-07-27 2018-07-27 Sammensætninger i form af en injicerbar vandig opløsning, som omfatter mindst et humant insulin A21G og en glucagonundertrykker med prandial virkning DK4019039T3 (da)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
FR1757172A FR3069436A1 (fr) 2017-07-27 2017-07-27 Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
FR1757184A FR3069437A1 (fr) 2017-07-28 2017-07-28 Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
FR1855250A FR3082426A1 (fr) 2018-06-14 2018-06-14 Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
EP18746942.4A EP3658115B1 (fr) 2017-07-27 2018-07-27 Compositions sous forme d'une solution aqueuse injectable comprenant au moins l'insuline humaine a21g et un suppresseur de glucagon a action prandiale

Publications (1)

Publication Number Publication Date
DK4019039T3 true DK4019039T3 (da) 2024-01-15

Family

ID=63047385

Family Applications (1)

Application Number Title Priority Date Filing Date
DK22156880.1T DK4019039T3 (da) 2017-07-27 2018-07-27 Sammensætninger i form af en injicerbar vandig opløsning, som omfatter mindst et humant insulin A21G og en glucagonundertrykker med prandial virkning

Country Status (16)

Country Link
US (2) US10610572B2 (da)
EP (2) EP3658115B1 (da)
JP (2) JP7240004B2 (da)
KR (1) KR102757948B1 (da)
CN (1) CN110996905B (da)
AU (3) AU2018308692A1 (da)
BR (1) BR112020001617A2 (da)
CA (1) CA3071064A1 (da)
DK (1) DK4019039T3 (da)
ES (2) ES2969277T3 (da)
IL (1) IL272141B2 (da)
MA (1) MA49678A (da)
PH (1) PH12020500122A1 (da)
PL (2) PL3658115T3 (da)
SG (1) SG11202000625PA (da)
WO (1) WO2019020820A2 (da)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
DK4019039T3 (da) * 2017-07-27 2024-01-15 Adocia Sammensætninger i form af en injicerbar vandig opløsning, som omfatter mindst et humant insulin A21G og en glucagonundertrykker med prandial virkning
FR3082426A1 (fr) * 2018-06-14 2019-12-20 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant au moins de l'insuline humaine a21g et un suppresseur de glucagon a action prandiale
EP3915571A1 (en) 2020-05-29 2021-12-01 Adocia Pharmaceutical composition in the form of an injectable aqueous solution including at least a rapid acting insulin analog and a glucagon suppressor with prandial action
EP3915572A1 (en) 2020-05-29 2021-12-01 Adocia Pharmaceutical composition in the form of an injectable aqueous solution including at least a rapid acting insulin analog and a glucagon suppressor with prandial action
EP4144362A1 (en) * 2021-09-06 2023-03-08 Adocia Compositions comprising short-acting hormones for treating or preventing obesity and pumps comprising said composition
EP4129324A1 (en) * 2021-08-02 2023-02-08 Adocia Compositions comprising at least an amylin receptor agonist and a glp-1 receptor agonist
EP4342486A1 (en) 2022-09-20 2024-03-27 Adocia Compositions comprising at least an insulin and an amylin receptor agonist for treating diabetes, in a patient/person having a bmi of more than 28 kg/m² and/or an hba1c of more than 7.6 %

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5008241A (en) 1985-03-12 1991-04-16 Novo Nordisk A/S Novel insulin peptides
CA1295330C (en) 1985-03-29 1992-02-04 James M. Greene Synthesis of inotropic imidazo(4,5-c) pyridine
GB8720115D0 (en) 1987-08-26 1987-09-30 Cooper G J S Treatment of diabetes mellitus
US5234906A (en) 1991-01-10 1993-08-10 Amylin Pharmaceuticals, Inc. Hyperglycemic compositions
HU222249B1 (hu) 1991-03-08 2003-05-28 Amylin Pharmaceuticals Inc. Eljárás amilin agonista peptidszármazékok és ezeket tartalmazó gyógyszerkészítmények előállítására
AU7685894A (en) 1993-09-07 1995-03-27 Amylin Pharmaceuticals, Inc. Methods for regulating gastrointestinal motility
US6410511B2 (en) 1997-01-08 2002-06-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
US7312196B2 (en) 1997-01-08 2007-12-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
US6506724B1 (en) 1999-06-01 2003-01-14 Amylin Pharmaceuticals, Inc. Use of exendins and agonists thereof for the treatment of gestational diabetes mellitus
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
US20080248999A1 (en) 2007-04-04 2008-10-09 Biodel Inc. Amylin formulations
JP5312054B2 (ja) * 2006-03-15 2013-10-09 ノボ・ノルデイスク・エー/エス アミリンとインスリンの混合物
WO2007135118A1 (en) 2006-05-24 2007-11-29 Novo Nordisk A/S Soluble, stable insulin-containing formulations
US9173991B2 (en) 2007-07-02 2015-11-03 Roche Diabetes Care, Inc. Device for drug delivery
US20100222251A1 (en) * 2007-09-11 2010-09-02 Novo Nordisk A/S Mixture comprising an amylin peptide and a protracted insulin
EP2060268A1 (en) 2007-11-15 2009-05-20 Novo Nordisk A/S Pharmaceutical compositions for pulmonary or nasal delivery of peptides
AU2011202239C1 (en) * 2010-05-19 2017-03-16 Sanofi Long-acting formulations of insulins
CN102199206B (zh) * 2011-03-17 2013-03-20 甘李药业股份有限公司 快速起效且在酸性条件下稳定的胰岛素类似物及其制剂
WO2013067022A1 (en) 2011-10-31 2013-05-10 Xeris Pharmaceuticals, Inc. Formulations for the treatment of diabetes
US20150174209A1 (en) 2012-05-25 2015-06-25 Amylin Pharmaceuticals. Llc Insulin-pramlintide compositions and methods for making and using them
US20160271226A1 (en) * 2013-09-30 2016-09-22 Wockhardt Limited Pharmaceutical composition
PE20171622A1 (es) * 2014-12-12 2017-11-02 Sanofi Aventis Deutschland Formulacion de relacion fija de insulina glargina/lixisenatida
DK4019039T3 (da) * 2017-07-27 2024-01-15 Adocia Sammensætninger i form af en injicerbar vandig opløsning, som omfatter mindst et humant insulin A21G og en glucagonundertrykker med prandial virkning

Also Published As

Publication number Publication date
CN110996905B (zh) 2026-03-17
EP4019039B1 (fr) 2023-10-11
ES2917893T3 (es) 2022-07-12
PH12020500122A1 (en) 2020-09-14
AU2025203948A1 (en) 2025-06-19
IL272141A (en) 2020-03-31
JP7240004B2 (ja) 2023-03-15
EP3658115A2 (fr) 2020-06-03
SG11202000625PA (en) 2020-02-27
CA3071064A1 (en) 2019-01-31
KR20200034779A (ko) 2020-03-31
WO2019020820A2 (fr) 2019-01-31
JP2020528439A (ja) 2020-09-24
PL4019039T3 (pl) 2024-03-18
CN110996905A (zh) 2020-04-10
ES2969277T3 (es) 2024-05-17
US20190054149A1 (en) 2019-02-21
EP4019039A1 (fr) 2022-06-29
WO2019020820A3 (fr) 2019-03-28
US10610572B2 (en) 2020-04-07
US11065305B2 (en) 2021-07-20
EP3658115B1 (fr) 2022-02-23
IL272141B2 (en) 2024-07-01
US20200188487A1 (en) 2020-06-18
AU2023202831A1 (en) 2023-05-25
PL3658115T4 (pl) 2022-08-08
BR112020001617A2 (pt) 2020-07-21
IL272141B1 (en) 2024-03-01
AU2018308692A1 (en) 2020-03-05
KR102757948B1 (ko) 2025-01-23
JP2023078143A (ja) 2023-06-06
MA49678A (fr) 2021-04-14
PL3658115T3 (pl) 2022-08-08

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