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SG11201809229VA - Pharmaceutical composition - Google Patents

Pharmaceutical composition

Info

Publication number
SG11201809229VA
SG11201809229VA SG11201809229VA SG11201809229VA SG11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA
Authority
SG
Singapore
Prior art keywords
international
ucb
rule
freeze
pct
Prior art date
Application number
SG11201809229VA
Inventor
Andrew Jeffrey Yates
Jan Ivo Massant
Original Assignee
Ucb Biopharma Sprl
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=56320265&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SG11201809229V(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Publication of SG11201809229VA publication Critical patent/SG11201809229VA/en

Links

Classifications

    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39566Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 16 November 2017 (16.11.2017) WIPO I PCT omit IIl mum o oimIE (10) International Publication Number WO 2017/194646 Al (51) International Patent Classification: A61K 39/395 (2006.01) A61K 9/08 (2006.01) A61K 9/19 (2006.01) A61K 47/26 (2006.01) (21) International Application Number: PCT/EP2017/061261 (22) International Filing Date: 11 May 2017 (11.05.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 1608323.0 12 May 2016 (12.05.2016) GB (71) Applicant: UCB BIOPHARMA SPRL [BE/BE]; 60, Al- lee de la Recherche, 1070 Brussels (BE). (72) Inventors: YATES, Andrew Jeffrey; c/o IPD, UCB Cell- tech, 208 Bath Road, Slough Berkshire SL1 2DT (GB). MASSANT, Jan Ivo; c/o IPD, UCB Celltech, 208 Bath Road, Slough Berkshire SL1 3WE (GB). (74) Agent: UCB INTELLECTUAL PROPERTY; c/o UCB Celltech, 208 Bath Road, Slough Berkshire SL1 3WE (GB). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (54) Title: PHARMACEUTICAL COMPOSITION Fig. 1 70 (57) : The present invention relates to pharmaceutical compositions comprising an antibody or a fragment thereof suitable for freeze-drying (i.e. lyophilizing) The pharmaceutical compositions, which comprise an antibody or an antigen-binding fragment thereof; from 1 % to 20% w/v sucrose; an amino acid or a mixture of amino acids; and surfactant, are provided as pharmaceutical compositions for freeze-drying; as freeze-dried (i.e. lyophilized) compositions which can be reconstituted into a solvent at the time of use or as reconstituted liquid formulations ready for administration. [Continued on next page] WO 2017/194646 Al MIDEDIMOMOIDEIROIDEMOMOIROMINIfillOINVOIMIE TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(1i)) of inventorship (Rule 4.17(iv)) Published: — with international search report (Art. 21(3)) — with sequence listing part of description (Rule 5.2(a))
SG11201809229VA 2016-05-12 2017-05-11 Pharmaceutical composition SG11201809229VA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1608323.0A GB201608323D0 (en) 2016-05-12 2016-05-12 Pharmaceutical compositions
PCT/EP2017/061261 WO2017194646A1 (en) 2016-05-12 2017-05-11 Pharmaceutical composition

Publications (1)

Publication Number Publication Date
SG11201809229VA true SG11201809229VA (en) 2018-11-29

Family

ID=56320265

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201809229VA SG11201809229VA (en) 2016-05-12 2017-05-11 Pharmaceutical composition

Country Status (18)

Country Link
US (1) US11407835B2 (en)
EP (1) EP3454899B1 (en)
JP (1) JP7126454B2 (en)
KR (1) KR102436694B1 (en)
CN (1) CN109069643A (en)
AR (1) AR108449A1 (en)
AU (1) AU2017264553A1 (en)
BR (1) BR112018072264A2 (en)
CA (1) CA3022124A1 (en)
CL (1) CL2018003178A1 (en)
CO (1) CO2018011733A2 (en)
EA (1) EA201892446A1 (en)
ES (1) ES2977545T3 (en)
GB (1) GB201608323D0 (en)
IL (1) IL262654A (en)
MX (1) MX2018013215A (en)
SG (1) SG11201809229VA (en)
WO (1) WO2017194646A1 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI703158B (en) 2015-09-18 2020-09-01 美商希佛隆公司 Antibodies that specifically bind to tl1a
MA47106A (en) 2016-12-21 2019-10-30 Amgen Inc ANTI-TNF ALPHA ANTIBODY FORMULATIONS
KR20250011715A (en) 2017-03-11 2025-01-21 셀렉타 바이오사이언시즈, 인크. Methods and compositions related to combined treatment with anti-inflammatories and synthetic nanocarriers comprising an immunosuppressant
GB201708655D0 (en) * 2017-05-31 2017-07-12 Ucb Biopharma Sprl Cell culture methods
MX2020009935A (en) * 2018-03-23 2021-01-08 Abbvie Deutschland Stable aqueous anti-tau antibody formulations.
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
BR112022018070A2 (en) * 2020-03-11 2022-10-25 Selecta Biosciences Inc METHODS AND COMPOSITIONS RELATED TO SYNTHETIC NANOVEHICLES
EP4173637A4 (en) * 2020-06-29 2024-08-07 Hanall Biopharma Co., Ltd. Formulation for anti-fcrn antibody
CN117615788A (en) * 2021-05-12 2024-02-27 安奈普泰斯生物有限公司 Antibody compositions
WO2023099607A1 (en) 2021-12-01 2023-06-08 UCB Biopharma SRL Formulations comprising fab-peg
JPWO2023224112A1 (en) * 2022-05-20 2023-11-23
AU2023281650A1 (en) 2022-05-30 2024-10-17 Hanall Biopharma Co., Ltd. Anti-fcrn antibody or antigen binding fragment thereof with improved stability
WO2024184444A1 (en) * 2023-03-08 2024-09-12 Immunovant Sciences Gmbh High concentration protein formulations with polysorbate excipients and methods of making the same
WO2025056011A1 (en) * 2023-09-13 2025-03-20 正大天晴药业集团股份有限公司 Pharmaceutical composition comprising anti-pd-1 antibody and second antibody

Family Cites Families (22)

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ATE454137T1 (en) * 2001-07-25 2010-01-15 Facet Biotech Corp STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION OF THE IGG ANTIBODY DACLIZUMAB
EP1697415A1 (en) * 2003-11-12 2006-09-06 Biogen Idec MA Inc. NEONATAL Fc RECEPTOR (FcRn)-BINDING POLYPEPTIDE VARIANTS, DIMERIC Fc BINDING PROTEINS AND METHODS RELATED THERETO
CN101124245A (en) * 2003-11-12 2008-02-13 比奥根艾迪克Ma公司 Neonatal Fc receptor (FcRn)-binding polypeptide variants, dimeric Fc binding proteins and methods related thereto
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
WO2007132480A2 (en) * 2006-05-12 2007-11-22 Bharat Biotech International Limited A composition useful as a vaccine
AR070315A1 (en) * 2008-02-07 2010-03-31 Merck & Co Inc ANTIBODIES 1B20 ANTAGONISTS OF PCSK9
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AU2010263058A1 (en) * 2009-06-18 2012-01-12 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
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US9458240B2 (en) 2010-12-10 2016-10-04 Novartis Pharma Ag Anti-BAFFR antibody formulations
CA2830806C (en) 2011-03-31 2020-05-12 Merck Sharp & Dohme Corp. Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
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US9592289B2 (en) * 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
PL2830658T3 (en) * 2012-03-26 2019-02-28 Sanofi Stable igg4 binding agent formulations
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GB201508180D0 (en) 2015-05-13 2015-06-24 Ucb Biopharma Sprl Antibodies

Also Published As

Publication number Publication date
GB201608323D0 (en) 2016-06-29
AU2017264553A1 (en) 2018-12-13
BR112018072264A2 (en) 2019-02-12
CO2018011733A2 (en) 2019-02-08
EP3454899B1 (en) 2024-03-20
MX2018013215A (en) 2019-02-21
JP2019514998A (en) 2019-06-06
KR20190008320A (en) 2019-01-23
EP3454899A1 (en) 2019-03-20
CN109069643A (en) 2018-12-21
CL2018003178A1 (en) 2019-02-01
CA3022124A1 (en) 2017-11-16
AR108449A1 (en) 2018-08-22
US11407835B2 (en) 2022-08-09
RU2018141591A (en) 2020-06-15
JP7126454B2 (en) 2022-08-26
WO2017194646A1 (en) 2017-11-16
EA201892446A1 (en) 2019-04-30
ES2977545T3 (en) 2024-08-26
KR102436694B1 (en) 2022-08-25
EP3454899C0 (en) 2024-03-20
RU2018141591A3 (en) 2021-01-13
IL262654A (en) 2018-12-31
US20200048346A1 (en) 2020-02-13

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