SG11201906557UA - Novel stable formulation for fxia antibodies - Google Patents
Novel stable formulation for fxia antibodiesInfo
- Publication number
- SG11201906557UA SG11201906557UA SG11201906557UA SG11201906557UA SG11201906557UA SG 11201906557U A SG11201906557U A SG 11201906557UA SG 11201906557U A SG11201906557U A SG 11201906557UA SG 11201906557U A SG11201906557U A SG 11201906557UA SG 11201906557U A SG11201906557U A SG 11201906557UA
- Authority
- SG
- Singapore
- Prior art keywords
- international
- gly
- pct
- rule
- berlin
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 230000015271 coagulation Effects 0.000 abstract 1
- 238000005345 coagulation Methods 0.000 abstract 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 abstract 1
- 229910000397 disodium phosphate Inorganic materials 0.000 abstract 1
- 235000019800 disodium phosphate Nutrition 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 230000008520 organization Effects 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 238000011321 prophylaxis Methods 0.000 abstract 1
- 102220240796 rs553605556 Human genes 0.000 abstract 1
- 238000002560 therapeutic procedure Methods 0.000 abstract 1
- 230000009424 thromboembolic effect Effects 0.000 abstract 1
- 230000001732 thrombotic effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
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)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Hematology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (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 26 July 2018 (26.07.2018) WIP0 I PCT omit °nolo moon HE mourn° oimIE (10) International Publication Number WO 2018/134184 Al (51) International Patent Classification: A61K 39/395 (2006.01) A61P 7/02 (2006.01) CO7K 16/36 (2006.01) (21) International Application Number: PCT/EP2018/050951 (22) International Filing Date: 16 January 2018 (16.01.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 17152108.1 19 January 2017 (19.01.2017) EP (71) Applicant: BAYER PHARMA AKTIENGESEL- LSCHAFT [DE/DE]; Miillerstr. 178, 13353 Berlin (DE). (72) Inventors: OLBRICH, Carsten; Geneisenaustr. 46, 10961 Berlin (DE). TRILL, Thomas; Lindenstr. 29, 16552 Schildow (DE). VEURINK, Marieke; Zimmerstrasse 1, 22085 Hamburg (DE). (74) Agent: BIP PATENTS; Alfred-Nobel-Str. 10, 40789 Mon- heim am Rhein NRW (DE). (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, JO, 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, 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(ii)) Published: — with international search report (Art. 21(3)) with sequence listing part of description (Rule 5.2(a)) (54) Title: NOVEL STABLE FORMULATION FOR FXIA ANTIBODIES Fig. I Second virial coefficient 1,00E-05 - 0,00E+00 - 1,00E-05 - -2,00E-05 -3,00E-05 - 4,00E-05 - 5,00E-05 - 6,00E-05 - • • His 30/Gly 100 His 50/Gly 50 • Na2HPO4 50 • His 5/Gly 200 1 2 • His 10/Gly 130 1-1 (57) : The present invention refers to novel liquid pharmaceutical formulations comprising human antibody against coagulation © factor FXIa as active ingredient. The invention also refers to lyophilizates of the specified liquid formulation and also to the use thereof el • in the therapy and prophylaxis of thrombotic or thromboembolic disord. O
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17152108 | 2017-01-19 | ||
| PCT/EP2018/050951 WO2018134184A1 (en) | 2017-01-19 | 2018-01-16 | Novel stable formulation for fxia antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11201906557UA true SG11201906557UA (en) | 2019-08-27 |
Family
ID=57914707
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11201906557UA SG11201906557UA (en) | 2017-01-19 | 2018-01-16 | Novel stable formulation for fxia antibodies |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20190367636A1 (en) |
| EP (1) | EP3570882B1 (en) |
| JP (1) | JP7072577B2 (en) |
| KR (1) | KR20190105588A (en) |
| CN (1) | CN110234353B (en) |
| AR (1) | AR110762A1 (en) |
| AU (1) | AU2018209118A1 (en) |
| BR (1) | BR112019014785A2 (en) |
| CA (1) | CA3050172A1 (en) |
| CY (1) | CY1124922T1 (en) |
| DK (1) | DK3570882T3 (en) |
| ES (1) | ES2904474T3 (en) |
| HR (1) | HRP20220011T1 (en) |
| HU (1) | HUE056858T2 (en) |
| IL (1) | IL267917B2 (en) |
| LT (1) | LT3570882T (en) |
| MX (1) | MX2019008544A (en) |
| PE (1) | PE20191476A1 (en) |
| PL (1) | PL3570882T3 (en) |
| PT (1) | PT3570882T (en) |
| RS (1) | RS62780B1 (en) |
| SG (1) | SG11201906557UA (en) |
| SI (1) | SI3570882T1 (en) |
| TW (1) | TWI753087B (en) |
| WO (1) | WO2018134184A1 (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JOP20200312A1 (en) | 2015-06-26 | 2017-06-16 | Novartis Ag | Factor xi antibodies and methods of use |
| TW201802121A (en) | 2016-05-25 | 2018-01-16 | 諾華公司 | Reversal binding agents for anti-factor XI/XIa antibodies and uses thereof |
| CA3048156A1 (en) | 2016-12-23 | 2018-06-28 | Novartis Ag | Factor xi antibodies and methods of use |
| US11634485B2 (en) | 2019-02-18 | 2023-04-25 | Eli Lilly And Company | Therapeutic antibody formulation |
| EP4076511A4 (en) * | 2019-12-20 | 2024-02-14 | Anthos Therapeutics, Inc. | Pharmaceutical formulations and dosage regimens for factor xi/xia antibodies |
| KR20230035079A (en) | 2020-07-03 | 2023-03-10 | 수조우 알파맵 씨오., 엘티디. | Coagulation factor XI (FXI) binding protein |
| KR20230118167A (en) * | 2020-12-11 | 2023-08-10 | 베링거 인겔하임 인터내셔날 게엠베하 | Formulation for multi-purpose application |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5485489B2 (en) * | 2000-08-11 | 2014-05-07 | 中外製薬株式会社 | Antibody-containing stabilized preparation |
| WO2004055164A2 (en) * | 2002-12-13 | 2004-07-01 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| MX2011003013A (en) * | 2008-09-19 | 2011-04-11 | Pfizer | Stable liquid antibody formulation. |
| BRPI0921845A2 (en) * | 2008-11-12 | 2019-09-17 | Medimmune Llc | stable sterile aqueous formulation, pharmaceutical unit dosage form, pre-filled syringe, and methods for treating a disease or disorder, treating or preventing rejection, depleting unique expressing t cells in a human patient, and disrupting central germinal architecture in a secondary lymphoid organ of a primate |
| AU2013258043B2 (en) * | 2012-05-10 | 2017-11-30 | Bayer Pharma Aktiengesellschaft | Antibodies capable of binding to the coagulation factor XI and/or its activated form factor XIa and uses thereof |
| WO2015059147A1 (en) * | 2013-10-25 | 2015-04-30 | Bayer Pharma Aktiengesellschaft | A novel stable formulation |
-
2018
- 2018-01-16 MX MX2019008544A patent/MX2019008544A/en unknown
- 2018-01-16 LT LTEPPCT/EP2018/050951T patent/LT3570882T/en unknown
- 2018-01-16 JP JP2019538638A patent/JP7072577B2/en active Active
- 2018-01-16 KR KR1020197020744A patent/KR20190105588A/en active IP Right Grant
- 2018-01-16 BR BR112019014785-3A patent/BR112019014785A2/en unknown
- 2018-01-16 IL IL267917A patent/IL267917B2/en unknown
- 2018-01-16 PT PT187026232T patent/PT3570882T/en unknown
- 2018-01-16 PL PL18702623T patent/PL3570882T3/en unknown
- 2018-01-16 PE PE2019001433A patent/PE20191476A1/en unknown
- 2018-01-16 HU HUE18702623A patent/HUE056858T2/en unknown
- 2018-01-16 WO PCT/EP2018/050951 patent/WO2018134184A1/en unknown
- 2018-01-16 RS RS20220004A patent/RS62780B1/en unknown
- 2018-01-16 EP EP18702623.2A patent/EP3570882B1/en active Active
- 2018-01-16 CA CA3050172A patent/CA3050172A1/en active Pending
- 2018-01-16 SG SG11201906557UA patent/SG11201906557UA/en unknown
- 2018-01-16 AU AU2018209118A patent/AU2018209118A1/en active Pending
- 2018-01-16 SI SI201830483T patent/SI3570882T1/en unknown
- 2018-01-16 US US16/478,029 patent/US20190367636A1/en not_active Abandoned
- 2018-01-16 HR HRP20220011TT patent/HRP20220011T1/en unknown
- 2018-01-16 ES ES18702623T patent/ES2904474T3/en active Active
- 2018-01-16 CN CN201880007721.1A patent/CN110234353B/en active Active
- 2018-01-16 DK DK18702623.2T patent/DK3570882T3/en active
- 2018-01-17 TW TW107101631A patent/TWI753087B/en active
- 2018-01-19 AR ARP180100130A patent/AR110762A1/en unknown
-
2022
- 2022-01-05 CY CY20221100009T patent/CY1124922T1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| SI3570882T1 (en) | 2022-01-31 |
| HUE056858T2 (en) | 2022-03-28 |
| KR20190105588A (en) | 2019-09-17 |
| IL267917B1 (en) | 2023-06-01 |
| WO2018134184A1 (en) | 2018-07-26 |
| AU2018209118A1 (en) | 2019-07-11 |
| JP7072577B2 (en) | 2022-05-20 |
| PL3570882T3 (en) | 2022-02-07 |
| LT3570882T (en) | 2021-12-10 |
| RS62780B1 (en) | 2022-01-31 |
| BR112019014785A2 (en) | 2020-05-12 |
| PE20191476A1 (en) | 2019-10-16 |
| CA3050172A1 (en) | 2018-07-26 |
| RU2019125947A (en) | 2021-02-19 |
| EP3570882B1 (en) | 2021-11-17 |
| IL267917A (en) | 2019-09-26 |
| ES2904474T3 (en) | 2022-04-05 |
| RU2019125947A3 (en) | 2021-05-25 |
| CN110234353B (en) | 2023-07-04 |
| TW201831170A (en) | 2018-09-01 |
| JP2020506175A (en) | 2020-02-27 |
| CY1124922T1 (en) | 2023-01-05 |
| EP3570882A1 (en) | 2019-11-27 |
| AR110762A1 (en) | 2019-05-02 |
| IL267917B2 (en) | 2023-10-01 |
| US20190367636A1 (en) | 2019-12-05 |
| PT3570882T (en) | 2022-01-11 |
| CN110234353A (en) | 2019-09-13 |
| TWI753087B (en) | 2022-01-21 |
| DK3570882T3 (en) | 2022-01-10 |
| HRP20220011T1 (en) | 2022-04-01 |
| MX2019008544A (en) | 2019-10-07 |
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