DK2704742T3 - Formulering til anti-4-7-antistof - Google Patents

Formulering til anti-4-7-antistof Download PDF

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Publication number
DK2704742T3
DK2704742T3 DK12722973.0T DK12722973T DK2704742T3 DK 2704742 T3 DK2704742 T3 DK 2704742T3 DK 12722973 T DK12722973 T DK 12722973T DK 2704742 T3 DK2704742 T3 DK 2704742T3
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antibody
formulation
seq
stable liquid
pharmaceutical formulation
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DK12722973.0T
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Willow Diluzio
Phuong M Nguyen
Csanad M Varga
Vaithianathan Palaniappan
Jason Brown
Irving H Fox
Catherine Scholz
Maria Rosario
Erica Helen Jenkins
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Millennium Pharm Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
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Claims (31)

1. Stabil flydende farmaceutisk formulering omfattende et anti-a437-antistof, citrat, og mindst én fri aminosyre, hvor anti-a4p7-antistoffet omfatter en letkæde variabel region omfattende en komplementaritetsbestemmende region 1 (CDR1) omfattende SEQ ID NO: 11, en CDR2 omfattende SEQ ID NO: 12, og en CDR3 omfattende SEQ ID NO: 13, og omfatter en tungkæde variabel region omfattende en CDR1 omfattende SEQ ID NO:8, en CDR2 omfattende SEQ ID NO:9, og en CDR3 omfattende SEQ ID NO: 10.
2. Den stabile flydende farmaceutiske formulering ifølge krav 1, hvor molforholdet mellem anti-a4p7-antistoffet og citrat er omkring 1:4 til omkring 1:100.
3. Den stabile flydende farmaceutiske formulering ifølge krav 1 eller 2, hvor den frie aminosyre er valgt fra gruppen bestående af histidin, alanin, arginin, glycin, glutaminsyre og kombinationer deraf.
4. Den stabile flydende formulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende et overfladeaktivt stof.
5. Den stabile flydende farmaceutiske formulering ifølge krav 4, hvor molforholdet mellem citrat og det overfladeaktive stof er omkring 3:1 til omkring 156:1.
6. Den stabile flydende formulering ifølge krav 4 eller 5, hvor det overfladeaktive stof er polysorbat 20, polysorbat 80, en poloxamer og kombinationer deraf.
7. Den stabile flydende formulering ifølge krav 6, hvor det overfladeaktive stof er polysorbat 80 og koncentrationen af polysorbat 80 er 0,01 % til 0,5 %.
8. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af kravene 1-7, hvor koncentrationen af citrat er 5 mM til 50 mM.
9. Stabil flydende farmaceutisk formulering omfattende mindst omkring 50 mg/ml til omkring 190 mg/ml anti-a437-antistof, en antioxidant eller chelaterende middel, og mindst én fri aminosyre, hvor anti-a4p7-antistoffet omfatter en letkæde variabel region omfattende en komplementaritetsbestemmende region 1 (CDR1) omfattende SEQ ID NO: 11, en CDR2 omfattende SEQ ID NO: 12, og en CDR3 omfattende SEQ ID NO: 13, og omfatter en tungkæde variabel region omfattende en CDR1 omfattende SEQ ID NO:8, en CDR2 omfattende SEQ ID NO:9, og en CDR3 omfattende SEQ ID NO: 10.
10. Stabil flydende farmaceutisk formulering omfattende et anti-c^7-antistof, en antioxidant eller chelaterende middel, og mindst én fri aminosyre, hvor anti-a4p7-antistoffet omfatter en letkæde variabel region omfattende en komplementaritetsbestemmende regionl (CDR1) omfattende SEQ ID NO: 11, en CDR2 omfattende SEQ ID NO: 12, og en CDR3 omfattende SEQ ID NO: 13, og omfatter en tungkæde variabel region omfattende en CDR1 omfattende SEQ ID NO:8, en CDR2 omfattende SEQ ID NO:9, og en CDR3 omfattende SEQ ID NO: 10, og hvor formuleringen haren pH på 6,1 til 7,0.
11. Den stabile flydende farmaceutiske formulering ifølge krav 9 eller 10, omfattende omkring 150 mg/ml til omkring 180 mg/ml anti-a4p7-antistof.
12. Den stabile flydende farmaceutiske formulering ifølge krav 9 eller 10, hvor antioxidanten eller chelaterende middel er citrat eller EDTA.
13. Den stabile flydende farmaceutiske formulering ifølge krav 12, hvor antioxidanten eller chelaterende middel er citrat.
14. Den stabile flydende farmaceutiske formulering ifølge krav 13, hvor koncentrationen af citrat er 5 mM til 50 mM.
15. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af kravene 9-15, yderligere omfattende et overfladeaktivt stof.
16. Den stabile flydende farmaceutiske formulering ifølge krav 15, hvor molforholdet af overfladeaktivt stof:antistof er fra omkring 0,7:1 til omkring 2,0:1.
17. Den stabile flydende farmaceutiske formulering ifølge krav 15, hvor molforholdet mellem antioxidant eller chelaterende middel og det overfladeaktive stof er omkring 3:1 til omkring 156:1.
18. Den stabile flydende farmaceutiske formulering ifølge krav 15, hvor det overfladeaktive stof er polysorbat 20, polysorbat 80, en poloxamer og kombinationer deraf.
19. Den stabile flydende farmaceutiske formulering ifølge krav 18, hvor det overfladeaktive stof er polysorbat 80 og koncentrationen af polysorbat 80 er 0,01 % til 0,5 %.
20. Den stabile flydende farmaceutiske formulering ifølge krav 9 eller 10, omfattende et anti-a4p7-antistof, citrat, histidin, arginin, og polysorbat 80, hvor Θη0-α4β7-θηθ5ίοίίβί omfatter en letkæde variabel region omfattende en komplementaritetsbestemmende regionl (CDR1) omfattende SEQ ID NO: 11, en CDR2 omfattende SEQ ID NO: 12, og en CDR3 omfattende SEQ ID NO: 13, og omfatter en tungkæde variabel region omfattende en CDR1 omfattende SEQ ID NO:8, en CDR2 omfattende SEQ ID NO:9, og en CDR3 omfattende SEQ ID NO: 10.
21. Den stabile flydende farmaceutiske formulering ifølge krav 20, hvor koncentrationen af anti-a437-antistof er mindst omkring 140 mg/ml.
22. Den stabile flydende farmaceutiske formulering ifølge krav 20 eller 21, hvor koncentrationen af histidin er 10 mM til 75 mM.
23. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af kravene 20-21, hvor koncentrationen af arginin er 50 mM til 150 mM.
24. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af kravene 20-23, hvor koncentrationen af citrat er 5 mM til 50 mM.
25. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af kravene 1-24, hvor antistoffet omfatter en tungkæde variabel region omfattende aminosyrer 20-140 af SEQ ID NO: 2 og en letkæde variabel region omfattende aminosyrer 20-131 af SEQ ID NO:4 eller aminosyrer 21-132 af SEQ ID NO:5.
26. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af de foregående krav, hvor antistoffet er vedolizumab.
27. Fremstillingsartikel omfattende en beholder, en stabil flydende farmaceutisk formulering ifølge et hvilket som helst af kravene 1-26, og instruktioner til dens anvendelse.
28. Artiklen ifølge krav 27, hvor den stabile flydende farmaceutiske formulering omfatter 108 mg af antistof.
29. Artiklen ifølge krav 27, hvor artiklen er en forfyldt sprøjte.
30. Den stabile flydende farmaceutiske formulering ifølge et hvilket som helst af kravene 1-26 eller fremstillingsartiklen ifølge et hvilket som helst af kravene 27 til 29 til anvendelse i behandling af inflammatorisk tarmsygdom.
31. Den stabile flydende farmaceutiske formulering eller fremstillingsartiklen ifølge krav 30, hvor den inflammatoriske tarmsygdom er Crohns sygdom eller ulcerøs colitis.
DK12722973.0T 2011-05-02 2012-05-02 Formulering til anti-4-7-antistof DK2704742T3 (da)

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US201161481522P 2011-05-02 2011-05-02
US201161544054P 2011-10-06 2011-10-06
PCT/US2012/036069 WO2012151247A2 (en) 2011-05-02 2012-05-02 FORMULATION FOR ANTI-α4β7 ANTIBODY

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DK2704742T3 true DK2704742T3 (da) 2017-10-23

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US (6) US10040855B2 (da)
EP (5) EP4378959A3 (da)
JP (5) JP6190359B2 (da)
KR (7) KR102014512B1 (da)
CN (4) CN108969469A (da)
AR (1) AR086238A1 (da)
AU (5) AU2012250872B2 (da)
CA (2) CA3051418C (da)
CL (3) CL2013003145A1 (da)
CO (1) CO6801648A2 (da)
CR (1) CR20130556A (da)
CY (1) CY1119436T1 (da)
DK (1) DK2704742T3 (da)
DO (1) DOP2013000252A (da)
EA (1) EA032625B1 (da)
EC (1) ECSP22046340A (da)
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GE (1) GEP20186866B (da)
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HR (1) HRP20171457T1 (da)
HU (1) HUE036664T2 (da)
IL (6) IL305583A (da)
LT (1) LT2704742T (da)
ME (1) ME02858B (da)
MX (4) MX354101B (da)
MY (1) MY188820A (da)
PE (1) PE20141672A1 (da)
PH (2) PH12018502221A1 (da)
PL (1) PL2704742T3 (da)
PT (1) PT2704742T (da)
RS (1) RS56429B1 (da)
SG (1) SG194730A1 (da)
SI (1) SI2704742T1 (da)
TW (5) TWI723339B (da)
UY (1) UY34054A (da)
WO (1) WO2012151247A2 (da)
ZA (2) ZA201308168B (da)

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