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HRP20140153T1 - Anti-sklerostin antitijela - Google Patents

Anti-sklerostin antitijela Download PDF

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Publication number
HRP20140153T1
HRP20140153T1 HRP20140153AT HRP20140153T HRP20140153T1 HR P20140153 T1 HRP20140153 T1 HR P20140153T1 HR P20140153A T HRP20140153A T HR P20140153AT HR P20140153 T HRP20140153 T HR P20140153T HR P20140153 T1 HRP20140153 T1 HR P20140153T1
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Croatia
Prior art keywords
antibody
bone loss
disease
use according
bone
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HRP20140153AT
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English (en)
Inventor
Ian Desmond Padhi
Graham Richard Jang
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Amgen Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40371592&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20140153(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc. filed Critical Amgen Inc.
Publication of HRP20140153T1 publication Critical patent/HRP20140153T1/hr

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    • 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
    • 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
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
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    • 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/08Antibacterial agents for leprosy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P5/00Drugs for disorders of the endocrine system
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    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • 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

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  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Obesity (AREA)
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Claims (13)

1. Anti-sklerostin antitijelo za uporabu u postupku inhibicije resorpcije kosti kod čovjeka, naznačen time, da postupak obuhvaća davanje osobi anti-sklerostin antitijela u količini od 1 mg/kg do 5 mg/kg, pri čemu je antitijelo antisklerostin antitijelo ili fragment koje: (a) pokazuje afinitet vezanja za sclerostin SEQ ID NO: 1 od manje ili jednako 1x10 - 7M, i (b) sadrži CDR-H1 od SEQ ID NO: 245, CDR -H2 od SEQ ID NO: 246, CDR -H3 od SEQ ID NO: 247, CDR - L1 u SEQ ID NO: 78, CDR - L2 SEQ ID NO: 79 iCDR - L3 SEQ ID NO: 80, pri čemu je: [image]
2. Antitijelo za uporabu prema zahtjevu 1, naznačeno time, da je količina Anti-sklerostin antitijela koja se primjenjuje od 1 mg/kg do 3 mg/kg.
3. Antitijelo za uporabu prema zahtjevu 1 ili 2, naznačeno time, da je količina Anti-sklerostin antitijela koja se primjenjuje oko 2 mg/kg.
4. Antitijelo za uporabu prema zahtjevu 1 ili 2, naznačeno time, da je količina Anti-sklerostin primjenjenog antitijela oko 3 mg/kg.
5. Antitijelo za uporabu prema zahtjevu 1, naznačeno time, da postupak uključuje davanje doze od 70 do 450 mg.
6. Antitijelo za uporabu prema zahtjevu 1, naznačeno time, da postupak uključuje davanje doze od oko 140 mg.
7. Antitijelo za uporabu prema zahtjevu 1, naznačeno time, da postupak uključuje davanje doze od oko 210 mg.
8. Antitijelo za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time, da se količina anti-sklerostin antitijela se daje subjektu jednom svaka dva tjedna.
9. Antitijelo za uporabu prema bilo kojem od zahtjeva 1 do 6, naznačeno time, da se anti-sklerostin antitijelo daje subjektu jednom mjesečno.
10. Antitijelo za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time, da je antitijelo humano antitijelo, humanizirano antitijelo, monoklonalno antitijelo ili himerno antitijelo.
11. Antitijelo za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da osoba pati od poremećaja povezanih s kostima odabranih iz skupine koju čine: ahondroplazija, cleidocranial dysostosis, enchondromatosis, fibrozna displazija, Gaucher-ova bolest, hipofosfatemični rahitis, Marfan-ov sindrom, multipla nasljedna egzostoza, neurofibromatoza, osteogenesis imperfecta, osteoporoza, Osteopoikilosis, sklerotične lezije, pseudoartroza, piogeni osteomijelitis, periodontalna bolest, gubitak kosti induciran anti-epileptički lijekovima, primarni i sekundarni hiperparatiroidizam, sindrom obiteljskog hiperparatiroidizam, gubitak kosti induciran bestežinskim stanjem, osteoporoza u muškaraca, gubitak koštane mase u postmenopauzi, osteoartritis, bubrega osteodistrofija, infiltrativni poremećaji kosti, oralni gubitak kosti, osteonekroza čeljusti, juvenilna Pagetova bolest, Melorheostosis, metaboličke bolesti kostiju, mastocitoza, anemija/bolest srpastih stanica, gubitak kosti povezan s presađivanjem organa, gubitak kosti u transplantacije bubrega, sistemski eritemski lupus, ankilozni spondilitis, epilepsija, juvenilni artritis, talasemija, mucopolysaccharidoses, Fabrijeva bolest, Turnerov sindrom, Downov sindrom, Klinefelterov sindrom, lepra, Perthesova bolest, idiopatska skolioza adolescenata, multisistemska bolest upalna bolest novorođenčeta, Winchester sindrom, Menkesova bolest, Wilsonova bolest, ishemijske bolesti kostiju, Legg - Calve - Perthesova bolest, regionalna migracijska osteoporoza, anemije stanja, stanja uzrokovana steroidima, gubitak koštane mase izazvana glukokortikoidima, gubitak koštane mase izazvana heparinom, poremećaj koštane srži, skorbut, pothranjenost, nedostatak kalcija, osteoporoza, osteopenija, alkoholizam, kronična bolest jetre, post- menopauze, kronična upalna stanja, reumatoidni artritis, upalne bolesti crijeva, ulcerozni kolitis, upalni kolitis, Crohnova bolest, oligomenoreja, amenoreja, trudnoća, dijabetes melitus, hipertireoza, poremećaji štitnjače, poremećaji nusštitnjače, Cushing-ova bolest, akromegalija, hipogonadizam, imobilizacija ili neaktivnost, refleksna simpatička distrofija, regionalna osteoporoza, gubitak kosti povezan sa instalacijom umjetnog zgloba, gubitak koštane mase povezan s HIV-om, gubitak kosti povezan sa nedostatkom hormona rasta, gubitak koštane mase povezan s cističnom fibrozom, gubitak koštane mase povezan s kemoterapijom, gubitak kosti induciranog tumora, gubitak koštane mase povezan s rakom, gubitak kosti povezan sa uklanjanjem organa koji izlučuju hormone, multipli mijelom, gubitak kosti induciran lijekovima, anoreksije nervoze, bolesti povezane s gubitkom kosti lica, bolesti povezane s gubitkom kranijalnih kosti, bolesti povezane s gubitkom čeljustnih kosti, gubitak koštane mase povezan s bolestima lubanje, gubitak koštane mase povezan sa starenjem, gubitak kosti lica povezan sa starenjem, gubitak kranijalnih kosti povezan sa starenjem, gubitak kosti čeljusti povezan sa starenjem, gubitak kosti povezan sa starenjem lubanje i gubitak kosti povezan sa svemirskim putovanjima.
12. Antitijelo za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time, da je osoba žena u post-menopauzi.
13. Antitijelo za uporabu prema bilo kojem od prethodnih zahtjeva, naznačeno time, da osoba pati od osteoporoze.
HRP20140153AT 2007-09-17 2014-02-18 Anti-sklerostin antitijela HRP20140153T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US97302407P 2007-09-17 2007-09-17
PCT/US2008/076679 WO2009039175A2 (en) 2007-09-17 2008-09-17 Method for inhibiting bone resorption

Publications (1)

Publication Number Publication Date
HRP20140153T1 true HRP20140153T1 (hr) 2014-04-25

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ID=40371592

Family Applications (4)

Application Number Title Priority Date Filing Date
HRP20240493TT HRP20240493T3 (hr) 2007-09-17 2008-09-17 Postupak za inhibiranje resorpcije kostiju
HRP20140153AT HRP20140153T1 (hr) 2007-09-17 2014-02-18 Anti-sklerostin antitijela
HRP20160872TT HRP20160872T1 (hr) 2007-09-17 2016-07-14 Postupak za inhibiciju resorpcije kosti
HRP20201438TT HRP20201438T1 (hr) 2007-09-17 2020-09-09 Metoda inhibiranja resorpcije kosti

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HRP20240493TT HRP20240493T3 (hr) 2007-09-17 2008-09-17 Postupak za inhibiranje resorpcije kostiju

Family Applications After (2)

Application Number Title Priority Date Filing Date
HRP20160872TT HRP20160872T1 (hr) 2007-09-17 2016-07-14 Postupak za inhibiciju resorpcije kosti
HRP20201438TT HRP20201438T1 (hr) 2007-09-17 2020-09-09 Metoda inhibiranja resorpcije kosti

Country Status (21)

Country Link
US (7) US8017120B2 (hr)
EP (5) EP4335510A3 (hr)
JP (2) JP5643094B2 (hr)
AR (2) AR068471A1 (hr)
AU (1) AU2008302313C1 (hr)
CA (2) CA2699905C (hr)
CL (1) CL2008002775A1 (hr)
CY (3) CY1114961T1 (hr)
DK (4) DK3085386T3 (hr)
ES (4) ES2975587T3 (hr)
FI (1) FI3725329T3 (hr)
HK (1) HK1182017A1 (hr)
HR (4) HRP20240493T3 (hr)
HU (3) HUE030168T2 (hr)
LT (3) LT2556841T (hr)
MX (1) MX2010002971A (hr)
PL (4) PL3725329T3 (hr)
PT (4) PT3085386T (hr)
SI (4) SI3085386T1 (hr)
TW (2) TWI612972B (hr)
WO (1) WO2009039175A2 (hr)

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