ES3005966T3 - Compositions suitable for use in neonates - Google Patents

Compositions suitable for use in neonates Download PDF

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Publication number
ES3005966T3
ES3005966T3 ES21807381T ES21807381T ES3005966T3 ES 3005966 T3 ES3005966 T3 ES 3005966T3 ES 21807381 T ES21807381 T ES 21807381T ES 21807381 T ES21807381 T ES 21807381T ES 3005966 T3 ES3005966 T3 ES 3005966T3
Authority
ES
Spain
Prior art keywords
composition
weeks
igf
polysorbate
concentration
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
ES21807381T
Other languages
English (en)
Spanish (es)
Inventor
Nazila Salamat-Miller
Katherine Taylor
Bing He
Indranil Bhattacharya
Linda Han
Benita Amsden
James Kranz
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.)
Oak Hill Bio Ltd
Original Assignee
Oak Hill Bio Ltd
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 Oak Hill Bio Ltd filed Critical Oak Hill Bio Ltd
Application granted granted Critical
Publication of ES3005966T3 publication Critical patent/ES3005966T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A61K38/1754Insulin-like growth factor binding proteins
    • 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
    • A61K38/30Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
ES21807381T 2020-10-19 2021-10-19 Compositions suitable for use in neonates Active ES3005966T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063093696P 2020-10-19 2020-10-19
PCT/US2021/055598 WO2022086953A1 (en) 2020-10-19 2021-10-19 Compositions suitable for use in neonates

Publications (1)

Publication Number Publication Date
ES3005966T3 true ES3005966T3 (en) 2025-03-17

Family

ID=78622033

Family Applications (1)

Application Number Title Priority Date Filing Date
ES21807381T Active ES3005966T3 (en) 2020-10-19 2021-10-19 Compositions suitable for use in neonates

Country Status (24)

Country Link
US (1) US20230381285A1 (enExample)
EP (2) EP4534073A3 (enExample)
JP (1) JP7827315B2 (enExample)
KR (1) KR20230113287A (enExample)
CN (1) CN117098547A (enExample)
AU (1) AU2021364523A1 (enExample)
CA (1) CA3194764A1 (enExample)
DK (1) DK4228676T3 (enExample)
ES (1) ES3005966T3 (enExample)
FI (1) FI4228676T3 (enExample)
HR (1) HRP20250193T1 (enExample)
HU (1) HUE070409T2 (enExample)
IL (1) IL301688A (enExample)
LT (1) LT4228676T (enExample)
MX (1) MX2023004426A (enExample)
PL (1) PL4228676T3 (enExample)
PT (1) PT4228676T (enExample)
RS (1) RS66493B1 (enExample)
SA (1) SA523440271B1 (enExample)
SI (1) SI4228676T1 (enExample)
SM (1) SMT202500093T1 (enExample)
TW (1) TWI912393B (enExample)
WO (1) WO2022086953A1 (enExample)
ZA (1) ZA202303162B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2025502349A (ja) 2022-01-19 2025-01-24 オーク ヒル バイオ リミテッド Igf-1/igfbpの酸化を低減するための組成物および方法
IL316413A (en) 2022-05-04 2024-12-01 Oak Hill Bio Ltd Combination therapy for preterm infants
WO2023242439A1 (en) * 2022-06-17 2023-12-21 Oak Hill Bio Limited Vascular stabilisation (preterm infants)
WO2023242440A1 (en) * 2022-06-17 2023-12-21 Oak Hill Bio Limited Treament of lungs in infants
KR20250079196A (ko) * 2022-10-04 2025-06-04 오크 힐 바이오 리미티드 Igf-1 복합체를 이용한 신생아 치료 방법

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL71991A (en) 1983-06-06 1994-05-30 Genentech Inc Preparation of human FGI and FGE in their processed form through recombinant AND tranology in prokaryotes
AU627423B2 (en) 1987-04-06 1992-08-27 Celtrix Pharmaceuticals, Inc. Human somatomedin carrier protein subunits and process for producing them
DK131988A (da) 1988-03-11 1989-09-12 Erasmus University Igf-bindingsprotein, dna-struktur, der koder for igf-bindingsproteinet og vektor indeholdende denne dna-struktur
US5258287A (en) 1988-03-22 1993-11-02 Genentech, Inc. DNA encoding and methods of production of insulin-like growth factor binding protein BP53
DE3854842T2 (de) 1988-04-12 1996-06-13 Amgen Boulder Inc Verfahren zur steigerung und zur hemmung der wirkung eines insulinähnlichen wachstumfaktors
GB8826451D0 (en) 1988-11-11 1988-12-14 Sandoz Ltd Improvements in/relating to organic compounds
IL92816A0 (en) 1988-12-22 1990-09-17 Biogrowth Inc Recombinant dna molecules,hosts,processes and human somatomedin carrier protein-like polypeptides
AU4238493A (en) 1992-05-08 1993-12-13 Thomas Jefferson University IGF-1 analogs
US5563046A (en) 1993-08-02 1996-10-08 Celtrix Pharmaceuticals, Inc. Fusion polypeptides and proteins
US5789547A (en) 1995-06-07 1998-08-04 Celtrix Pharmaceuticals, Inc. Method of producing insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) with correct folding and disulfide bonding
US5783556A (en) * 1996-08-13 1998-07-21 Genentech, Inc. Formulated insulin-containing composition
US5985830A (en) * 1996-09-16 1999-11-16 Dalhousie University Use of IGF-I for the treatment of kidney disorders
US6121416A (en) 1997-04-04 2000-09-19 Genentech, Inc. Insulin-like growth factor agonist molecules
US6436897B2 (en) * 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
US20020028764A1 (en) * 2000-09-04 2002-03-07 Aarhus Amt. Treatment of acute and chronic liver disease
WO2006138181A2 (en) * 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
EP2501367B1 (en) * 2009-11-17 2015-01-21 Ipsen Pharma S.A.S. Formulation for HGH and RHIGF-1 combination
HK1217633A1 (zh) * 2013-01-15 2017-01-20 Teva Pharmaceutical Industries Ltd. 冻乾方法
KR20140119396A (ko) * 2013-03-29 2014-10-10 삼성전자주식회사 단백질 약물의 액상 제형
KR20200097679A (ko) * 2017-09-11 2020-08-19 샤이어 휴먼 지네틱 테라피즈 인크. 만성 폐 질환 치료를 위한 방법 및 조성물
JP2025502349A (ja) * 2022-01-19 2025-01-24 オーク ヒル バイオ リミテッド Igf-1/igfbpの酸化を低減するための組成物および方法
WO2023139250A1 (en) * 2022-01-24 2023-07-27 Oak Hill Bio Limited Lot release assays for igf‐1/igfbp complexes

Also Published As

Publication number Publication date
DK4228676T3 (da) 2025-01-20
SA523440271B1 (ar) 2025-04-10
HUE070409T2 (hu) 2025-06-28
SI4228676T1 (sl) 2025-03-31
ZA202303162B (en) 2024-08-28
WO2022086953A9 (en) 2022-07-07
CN117098547A (zh) 2023-11-21
RS66493B1 (sr) 2025-03-31
JP7827315B2 (ja) 2026-03-10
FI4228676T3 (fi) 2025-02-26
US20230381285A1 (en) 2023-11-30
HRP20250193T1 (hr) 2025-04-11
PT4228676T (pt) 2025-01-24
IL301688A (en) 2023-05-01
KR20230113287A (ko) 2023-07-28
JP2023550203A (ja) 2023-11-30
EP4228676B1 (en) 2025-01-08
EP4534073A3 (en) 2025-05-14
MX2023004426A (es) 2023-08-04
LT4228676T (lt) 2025-02-10
WO2022086953A1 (en) 2022-04-28
TWI912393B (zh) 2026-01-21
AU2021364523A1 (en) 2023-04-06
SMT202500093T1 (it) 2025-03-12
EP4534073A2 (en) 2025-04-09
PL4228676T3 (pl) 2025-04-07
EP4228676A1 (en) 2023-08-23
TW202233228A (zh) 2022-09-01
CA3194764A1 (en) 2022-04-28

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