JP2019504882A5 - - Google Patents
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- Publication number
- JP2019504882A5 JP2019504882A5 JP2018557209A JP2018557209A JP2019504882A5 JP 2019504882 A5 JP2019504882 A5 JP 2019504882A5 JP 2018557209 A JP2018557209 A JP 2018557209A JP 2018557209 A JP2018557209 A JP 2018557209A JP 2019504882 A5 JP2019504882 A5 JP 2019504882A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- composition according
- histidine
- concentration
- present
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
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- 239000008194 pharmaceutical composition Substances 0.000 claims 20
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 9
- 229960002885 histidine Drugs 0.000 claims 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 150000001720 carbohydrates Chemical class 0.000 claims 4
- 235000014633 carbohydrates Nutrition 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- 239000002736 nonionic surfactant Substances 0.000 claims 4
- QZNNVYOVQUKYSC-JEDNCBNOSA-N (2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 claims 3
- 229920001213 Polysorbate 20 Polymers 0.000 claims 3
- 229930006000 Sucrose Natural products 0.000 claims 3
- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 claims 3
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims 3
- 206010047571 Visual impairment Diseases 0.000 claims 3
- 239000005557 antagonist Substances 0.000 claims 3
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 3
- 229940068977 polysorbate 20 Drugs 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 208000029257 vision disease Diseases 0.000 claims 3
- 230000004393 visual impairment Effects 0.000 claims 3
- 208000005590 Choroidal Neovascularization Diseases 0.000 claims 2
- 206010060823 Choroidal neovascularisation Diseases 0.000 claims 2
- 206010012688 Diabetic retinal oedema Diseases 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- 108010081667 aflibercept Proteins 0.000 claims 2
- 229960002833 aflibercept Drugs 0.000 claims 2
- 206010064930 age-related macular degeneration Diseases 0.000 claims 2
- 201000011190 diabetic macular edema Diseases 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 208000002780 macular degeneration Diseases 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 125000002066 L-histidyl group Chemical group [H]N1C([H])=NC(C([H])([H])[C@](C(=O)[*])([H])N([H])[H])=C1[H] 0.000 claims 1
- 208000001344 Macular Edema Diseases 0.000 claims 1
- 206010025415 Macular oedema Diseases 0.000 claims 1
- 108091008605 VEGF receptors Proteins 0.000 claims 1
- 102000009484 Vascular Endothelial Growth Factor Receptors Human genes 0.000 claims 1
- 208000001309 degenerative myopia Diseases 0.000 claims 1
- 230000004340 degenerative myopia Effects 0.000 claims 1
- 108020001507 fusion proteins Proteins 0.000 claims 1
- 102000037865 fusion proteins Human genes 0.000 claims 1
- 229910017053 inorganic salt Inorganic materials 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 201000010230 macular retinal edema Diseases 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 208000004644 retinal vein occlusion Diseases 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16152767.6 | 2016-01-26 | ||
| EP16152767 | 2016-01-26 | ||
| EP16199497 | 2016-11-18 | ||
| EP16199497.5 | 2016-11-18 | ||
| PCT/EP2017/051662 WO2017129685A1 (en) | 2016-01-26 | 2017-01-26 | Liquid formulation of a vegf antagonist |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019504882A JP2019504882A (ja) | 2019-02-21 |
| JP2019504882A5 true JP2019504882A5 (https=) | 2019-12-12 |
| JP6953433B2 JP6953433B2 (ja) | 2021-10-27 |
Family
ID=57882094
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018557209A Active JP6953433B2 (ja) | 2016-01-26 | 2017-01-26 | Vegfアンタゴニストを含む液体医薬組成物および同医薬組成物を含有する充填済みシリンジ |
Country Status (6)
| Country | Link |
|---|---|
| US (3) | US10576128B2 (https=) |
| EP (1) | EP3407868A1 (https=) |
| JP (1) | JP6953433B2 (https=) |
| AU (1) | AU2017213103B2 (https=) |
| CA (1) | CA3011638C (https=) |
| WO (1) | WO2017129685A1 (https=) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7608261B2 (en) | 2006-06-16 | 2009-10-27 | Regeneron Pharmacuticals, Inc. | VEGF antagonist formulations suitable for intravitreal administration |
| KR101808234B1 (ko) | 2015-06-23 | 2017-12-12 | (주)알테오젠 | IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제 |
| AU2017213103B2 (en) | 2016-01-26 | 2022-08-11 | Formycon Ag | Liquid formulation of a VEGF antagonist |
| CA3038894A1 (en) * | 2016-09-28 | 2018-04-05 | Board Of Regents, The University Of Texas System | Antibody and protein therapeutic formulations and uses thereof |
| CN109937034B (zh) * | 2016-11-21 | 2022-09-16 | 济世-伊沃泰克生物制品有限公司 | 阿柏西普制剂及其用途 |
| DK3600456T3 (da) | 2017-03-27 | 2023-10-02 | Regeneron Pharma | Fremgangsmåde til sterilisering |
| WO2019020777A1 (en) | 2017-07-26 | 2019-01-31 | Formycon Ag | LIQUID FORMULATION OF A VEGF ANTAGONIST |
| MA50174A (fr) | 2017-09-18 | 2020-07-29 | Amgen Inc | Formules de protéines de fusion vegfr-fc |
| JP7536640B2 (ja) * | 2017-11-17 | 2024-08-20 | アムジエン・インコーポレーテツド | VEGFR-Fc融合タンパク質製剤 |
| CA3081094A1 (en) * | 2017-11-20 | 2019-05-23 | Alison J. GILLESPIE | Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof |
| US11103552B2 (en) * | 2018-05-10 | 2021-08-31 | Regeneron Pharmaceuticals, Inc. | High concentration VEGF receptor fusion protein containing formulations |
| AU2019333047A1 (en) * | 2018-08-30 | 2020-12-03 | Regeneron Pharmaceuticals, Inc. | Methods for characterizing protein complexes |
| WO2020055123A1 (ko) * | 2018-09-10 | 2020-03-19 | 삼성바이오에피스 주식회사 | 단백질을 포함하는 액상 조성물 |
| WO2020087003A1 (en) | 2018-10-26 | 2020-04-30 | Amgen Inc. | Formulations comprising a tris buffer and a protein |
| EP3873519A1 (en) | 2018-10-29 | 2021-09-08 | F. Hoffmann-La Roche AG | Antibody formulation |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| CN118718181A (zh) | 2019-06-05 | 2024-10-01 | 里珍纳龙药品有限公司 | 用于精确剂量递送的装置及方法 |
| US11180540B2 (en) | 2019-12-06 | 2021-11-23 | Regeneron Pharmaceuticals, Inc. | Anti-VEGF protein compositions and methods for producing the same |
| KR20220149690A (ko) * | 2020-03-04 | 2022-11-08 | 상하이 헨리우스 바이오테크, 인크. | 베바시주맙을 포함하는 약물 조제용 제제 |
| JP2023525034A (ja) | 2020-05-08 | 2023-06-14 | 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 | Vegfトラップおよびミニトラップならびに眼障害およびがんの治療方法 |
| US20230312683A1 (en) * | 2020-07-31 | 2023-10-05 | Celltrion Inc. | Stable pharmaceutical preparation |
| US11723955B1 (en) | 2022-05-13 | 2023-08-15 | Allgenesis Biotherapeutics Inc. | VEGFR fusion protein pharmaceutical composition |
| USD1120314S1 (en) | 2022-11-30 | 2026-03-24 | Regeneron Pharmaceuticals, Inc. | Dose delivery device |
| WO2025217334A1 (en) * | 2024-04-09 | 2025-10-16 | Regeneron Pharmaceuticals, Inc. | Low concentration vegf receptor fusion protein containing formulations |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5731144A (en) | 1990-06-11 | 1998-03-24 | Nexstar Pharmaceuticals, Inc. | High affinity TGFβ nucleic acid ligands |
| US6124449A (en) | 1990-06-11 | 2000-09-26 | Nexstar Pharmaceuticals, Inc. | High affinity TGFβ nucleic acid ligands and inhibitors |
| US5731424A (en) | 1990-06-11 | 1998-03-24 | Nexstar Pharmaceuticals, Inc. | High affinity TGFβ nucleic acid ligands and inhibitors |
| US6582959B2 (en) | 1991-03-29 | 2003-06-24 | Genentech, Inc. | Antibodies to vascular endothelial cell growth factor |
| AU732820B2 (en) | 1995-06-02 | 2001-05-03 | Nexstar Pharmaceuticals, Inc. | High-affinity oligonucleotide ligands to growth factors |
| BR9207175A (pt) | 1992-10-28 | 1995-12-12 | Genentech Inc | Composição contendo antagonista de fator de crescimento de célula endotelial vascular sequência aminoácida de anticorpo monoclonal polipeptídeo e método de tratamento de tumor em mamífero |
| IL117645A (en) | 1995-03-30 | 2005-08-31 | Genentech Inc | Vascular endothelial cell growth factor antagonists for use as medicaments in the treatment of age-related macular degeneration |
| US20020032315A1 (en) | 1997-08-06 | 2002-03-14 | Manuel Baca | Anti-vegf antibodies |
| EP2338915A3 (en) | 1997-04-07 | 2011-10-12 | Genentech, Inc. | Anti-VEGF antibodies |
| JP3957765B2 (ja) | 1997-04-07 | 2007-08-15 | ジェネンテク・インコーポレイテッド | 抗vegf抗体 |
| US6703020B1 (en) | 1999-04-28 | 2004-03-09 | Board Of Regents, The University Of Texas System | Antibody conjugate methods for selectively inhibiting VEGF |
| CN100523187C (zh) | 1999-06-08 | 2009-08-05 | 里珍纳龙药品有限公司 | 具有改善的药物动力学特性的修饰嵌合多肽 |
| WO2005044853A2 (en) | 2003-11-01 | 2005-05-19 | Genentech, Inc. | Anti-vegf antibodies |
| CN102614134B (zh) | 2005-03-25 | 2016-09-07 | 瑞泽恩制药公司 | Vegf拮抗剂制剂 |
| US7608261B2 (en) * | 2006-06-16 | 2009-10-27 | Regeneron Pharmacuticals, Inc. | VEGF antagonist formulations suitable for intravitreal administration |
| WO2007148334A1 (en) * | 2006-06-20 | 2007-12-27 | Ben-Gurion University Of The Negev Research And Development Authority | Amphiphilic peptides and hydrogel matrices thereof for bone repair |
| EP2167127A1 (en) | 2007-07-10 | 2010-03-31 | F. Hoffmann-Roche AG | Novel formulation |
| LT3216803T (lt) | 2008-06-25 | 2020-06-10 | Novartis Ag | Stabilūs ir tirpūs antikūnai, slopinantys vegf |
| EP3785735A1 (en) | 2008-11-03 | 2021-03-03 | Molecular Partners AG | Binding proteins inhibiting the vegf-a receptor interaction |
| TWI510246B (zh) | 2010-04-30 | 2015-12-01 | Molecular Partners Ag | 抑制vegf-a受體交互作用的經修飾結合性蛋白質 |
| US20130323242A1 (en) * | 2012-06-01 | 2013-12-05 | Ophthotech Corp. | Compositions comprising an anti-pdgf aptamer and a vegf antagonist |
| AU2013267310A1 (en) * | 2012-06-01 | 2014-12-11 | Ophthotech Corporation | Compositions comprising an anti-PDGF aptamer and a VEGF antagonist |
| EP2890389A1 (en) * | 2012-08-28 | 2015-07-08 | Novartis AG | Use of a vegf antagonist in treating ocular vascular proliferative diseases |
| JP2016522249A (ja) * | 2013-06-20 | 2016-07-28 | ノバルティス アーゲー | 脈絡膜血管新生の治療におけるvegfアンタゴニストの使用 |
| EP3071181B1 (en) | 2013-11-18 | 2021-03-24 | Formycon AG | Pharmaceutical composition of an anti-vegf antibody |
| RU2702748C2 (ru) | 2014-05-12 | 2019-10-11 | Формикон Аг | Предварительно заполненный пластиковый шприц, содержащий антагонист vegf |
| KR101808234B1 (ko) * | 2015-06-23 | 2017-12-12 | (주)알테오젠 | IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제 |
| CN108290004A (zh) | 2015-11-18 | 2018-07-17 | 福尔密孔股份公司 | 含有vegf拮抗剂的预填充塑料注射器 |
| AU2017213103B2 (en) | 2016-01-26 | 2022-08-11 | Formycon Ag | Liquid formulation of a VEGF antagonist |
-
2017
- 2017-01-26 AU AU2017213103A patent/AU2017213103B2/en active Active
- 2017-01-26 EP EP17701350.5A patent/EP3407868A1/en active Pending
- 2017-01-26 CA CA3011638A patent/CA3011638C/en active Active
- 2017-01-26 WO PCT/EP2017/051662 patent/WO2017129685A1/en not_active Ceased
- 2017-01-26 US US16/072,638 patent/US10576128B2/en active Active
- 2017-01-26 JP JP2018557209A patent/JP6953433B2/ja active Active
-
2020
- 2020-01-14 US US16/742,585 patent/US20200237862A1/en not_active Abandoned
-
2023
- 2023-02-23 US US18/173,549 patent/US12551529B2/en active Active
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