Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Express Scripts
Moodys
Medtronic
Johnson and Johnson

Last Updated: January 18, 2020

DrugPatentWatch Database Preview

Claims for Patent: 9,982,032

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

Summary for Patent: 9,982,032
Title:Stable liquid formulation of fusion protein with IgG Fc domain
Abstract: A stable liquid formulation includes a fusion protein having an Fc domain of a human immunoglobulin G (IgG), in particular, a protein in which an Fc domain of a human immunoglobulin G (IgG) and a soluble extracellular domain of a vascular endothelial growth factor (VEGF) receptor are fused (e.g., aflibercept)). A composition for stabilizing a protein and a method for stabilizing a protein in which an Fc domain of an IgG and a soluble extracellular domain of a VEGF receptor are fused are disclosed. The present invention improves therapeutic effects on various ophthalmic diseases (e.g., retinal vein occlusion, diabetic macular edema, choroidal neovascularization and wet age-related macular degeneration, etc.) caused by abnormal angiogenesis, while pursuing stabilization of bioactivity through a stable liquid formulation suitable for intravitreal injection of an anti-VEGF-Fc fusion protein including aflibercept.
Inventor(s): Park; Soon Jae (Daejeon, KR), Chung; Hye-Shin (Daejeon, KR), Kim; Jin Hwan (Daejeon, KR), Kim; Yong Mo (Daejeon, KR), Kim; Jun Young (Daejeon, KR)
Assignee: ALTEOGEN, INC. (Daejeon, KR)
Application Number:15/190,378
Patent Claims:1. A liquid formulation, consisting of: 10 to 100 mg/ml of a protein in which a soluble extracellular domain of a vascular endothelial growth factor (VEGF) receptor and an Fc domain of a human immunoglobulin G (IgG) are fused; a buffer consisting of a histidine salt and having pH ranging from 5.7 to 6.2; and a sugar selected from the group consisting of more than 6%, but not more than 10% of sucrose, trehalose, mannitol, and glucose; a surfactant selected from the group consisting of 0% to 0.1% of polysorbate 20 and polysorbate 80; wherein the soluble extracellular domain of the VEGF receptor comprises the immunoglobulin-like domain 2 of the human Flt1 VEGF receptor-1 and the immunoglobulin-like domain 3 of the human Flk1 VEGF receptor-2; and the histidine salt is 10 mM to 50 mM of histidine-HCl or histidine-acetate.

2. The liquid formulation of claim 1, comprising the fusion protein in an amount of 10 to 40 mg/ml.

3. A liquid formulation, consisting of: a buffer consisting of a histidine salt and having pH ranging from 5.7 to 6.2; a sugar selected from the group consisting of more than 6%, but not more than 10% of sucrose, trehalose, mannitol, and glucose; a surfactant selected from the group consisting of 0% to 0.1% of polysorbate 20 and polysorbate 80; and 10 to 100 mg/ml of aflibercept; wherein the histidine salt is 10 mM to 50 mM of histidine-HCl or histidine-acetate.

4. The liquid formulation of claim 1, wherein the liquid formulation is suitable for intravitreal injection.

Details for Patent 9,982,032

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Regeneron Pharmaceuticals EYLEA aflibercept INJECTABLE; INJECTION 125387 001 2011-11-18   Start Trial ALTEOGEN, INC. (Daejeon, KR) 2035-06-23 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Merck
AstraZeneca
Harvard Business School
Baxter
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.