KR102136208B1 - 항-α4β7 항체에 대한 제형 - Google Patents

항-α4β7 항체에 대한 제형 Download PDF

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KR102136208B1
KR102136208B1 KR1020197024347A KR20197024347A KR102136208B1 KR 102136208 B1 KR102136208 B1 KR 102136208B1 KR 1020197024347 A KR1020197024347 A KR 1020197024347A KR 20197024347 A KR20197024347 A KR 20197024347A KR 102136208 B1 KR102136208 B1 KR 102136208B1
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antibody
formulation
syringe
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KR20190100451A (ko
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윌로우 딜루지오
푸옹 엠. 구옌
사나드 엠. 바르가
바이티아나단 팔라니아판
제이슨 브라운
얼빙 에이치. 폭스
캐서린 숄츠
헬렌 젠킨스
마리아 로사리오
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밀레니엄 파머슈티컬스 인코퍼레이티드
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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
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    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Virology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • AIDS & HIV (AREA)
KR1020197024347A 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형 Active KR102136208B1 (ko)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020207020503A KR102308938B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161481522P 2011-05-02 2011-05-02
US61/481,522 2011-05-02
US201161544054P 2011-10-06 2011-10-06
US61/544,054 2011-10-06
PCT/US2012/036069 WO2012151247A2 (en) 2011-05-02 2012-05-02 FORMULATION FOR ANTI-α4β7 ANTIBODY

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020187018702A Division KR102014512B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형

Related Child Applications (1)

Application Number Title Priority Date Filing Date
KR1020207020503A Division KR102308938B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형

Publications (2)

Publication Number Publication Date
KR20190100451A KR20190100451A (ko) 2019-08-28
KR102136208B1 true KR102136208B1 (ko) 2020-07-21

Family

ID=46147702

Family Applications (8)

Application Number Title Priority Date Filing Date
KR1020217031194A Active KR102493433B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020237002891A Ceased KR20230021758A (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020137031205A Active KR101875155B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020197024347A Active KR102136208B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020207020503A Active KR102308938B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020187018702A Active KR102014512B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020257019939A Pending KR20250093426A (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020177012979A Active KR101884406B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형

Family Applications Before (3)

Application Number Title Priority Date Filing Date
KR1020217031194A Active KR102493433B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020237002891A Ceased KR20230021758A (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020137031205A Active KR101875155B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형

Family Applications After (4)

Application Number Title Priority Date Filing Date
KR1020207020503A Active KR102308938B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020187018702A Active KR102014512B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020257019939A Pending KR20250093426A (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형
KR1020177012979A Active KR101884406B1 (ko) 2011-05-02 2012-05-02 항-α4β7 항체에 대한 제형

Country Status (38)

Country Link
US (7) US10040855B2 (enExample)
EP (5) EP2704742B1 (enExample)
JP (6) JP6190359B2 (enExample)
KR (8) KR102493433B1 (enExample)
CN (4) CN103533959B (enExample)
AR (1) AR086238A1 (enExample)
AU (5) AU2012250872B2 (enExample)
CA (2) CA2834900C (enExample)
CL (3) CL2013003145A1 (enExample)
CO (1) CO6801648A2 (enExample)
CR (1) CR20130556A (enExample)
CY (1) CY1119436T1 (enExample)
DK (1) DK2704742T3 (enExample)
DO (1) DOP2013000252A (enExample)
EA (1) EA032625B1 (enExample)
EC (1) ECSP22046340A (enExample)
ES (1) ES2646717T3 (enExample)
GE (1) GEP20186866B (enExample)
HK (1) HK1253911A1 (enExample)
HR (1) HRP20171457T1 (enExample)
HU (1) HUE036664T2 (enExample)
IL (6) IL274846B2 (enExample)
LT (1) LT2704742T (enExample)
ME (1) ME02858B (enExample)
MX (4) MX384203B (enExample)
MY (1) MY188820A (enExample)
PE (1) PE20141672A1 (enExample)
PH (3) PH12013502237A1 (enExample)
PL (1) PL2704742T3 (enExample)
PT (1) PT2704742T (enExample)
RS (1) RS56429B1 (enExample)
SG (1) SG194730A1 (enExample)
SI (1) SI2704742T1 (enExample)
SM (1) SMT201700515T1 (enExample)
TW (5) TWI698254B (enExample)
UY (1) UY34054A (enExample)
WO (1) WO2012151247A2 (enExample)
ZA (2) ZA201308168B (enExample)

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HRP20181419T1 (hr) 2010-01-06 2018-11-16 Dyax Corp. Plazma kalikrein vezni proteini
JP5918246B2 (ja) * 2010-10-06 2016-05-18 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 抗インターロイキン−４受容体（ｉｌ−４ｒ）抗体を含有する安定化製剤
IL269565B2 (en) 2011-01-06 2024-06-01 Dyax Corp Plasma kallikrein binding proteins
MX347602B (es) 2011-01-28 2017-05-03 Sanofi Biotechnology Composiciones farmaceuticas que comprenden anticuerpos humanos frente a pcsk9.
LT2704742T (lt) 2011-05-02 2017-10-25 Millennium Pharmaceuticals, Inc. Anti-alfa4beta7 antikūno kompozicija
UA116189C2 (uk) 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
AU2012278802B2 (en) 2011-07-06 2015-11-26 Société des Produits Nestlé S.A. Assays for detecting neutralizing autoantibodies to biologic therapy with TNF alpha
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
US9764093B2 (en) * 2012-11-30 2017-09-19 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
CA3208188A1 (en) 2013-03-15 2014-09-25 Takeda Pharmaceutical Company Limited Anti-plasma kallikrein antibodies
CN117717569A (zh) * 2013-07-05 2024-03-19 恒星生物群落有限公司 口服组合物
JP6798882B2 (ja) * 2013-11-29 2020-12-09 アレス トレーディング ソシエテ アノニム ＴＮＦＲ及びＦｃ領域を含む融合タンパク質の液体製剤
CN106132442B (zh) 2014-01-21 2023-07-14 武田药品工业株式会社 血浆激肽释放酶结合蛋白和其在治疗遗传性血管性水肿中的用途
KR102555955B1 (ko) 2014-03-27 2023-07-18 다케다 파머수티컬 컴패니 리미티드 당뇨병성 황반 부종의 치료를 위한 조성물 및 방법
MA40592A (fr) 2014-10-06 2016-04-14 Chemocentryx Inc Compositions et méthodes pour le traitement d'une maladie inflammatoire de l'intestin à l'aide d'une polythérapie à base d'inhibiteurs à petites molécules de récepteur 9 de chimiokine c-c (ccr9) et d'anticorps bloquants anti-intégrine alpha4beta7
WO2016086147A1 (en) 2014-11-26 2016-06-02 Millennium Pharmaceuticals, Inc. Vedolizumab for the treatment of fistulizing crohn's disease
CN106999588A (zh) * 2014-12-03 2017-08-01 瑞士杰特贝林生物制品有限公司 具有增加的稳定性的包含免疫球蛋白的药物产品
MX2017007232A (es) 2014-12-05 2017-10-16 Nestec Sa Ensayos de desplazamiento por movilidad homogeneos indirectos para la deteccion de productos biologicos en muestras de pacientes.
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
US20170360926A1 (en) 2014-12-24 2017-12-21 Millennium Pharmaceuticals, Inc. PREDICTING OUTCOME OF TREATMENT WITH AN ANTI-alpha4beta7 INTEGRIN ANTIBODY
MA41636A (fr) 2015-03-06 2018-01-09 Millennium Pharm Inc Méthode de traitement de la cholangite sclérosante primitive
AU2016243160B2 (en) * 2015-03-30 2022-02-24 Takeda Pharmaceutical Company Limited Plasma kallikrein inhibitors and uses thereof for preventing hereditary angioedema attack
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