Claims for Patent: 8,465,739

Summary for Patent: 8,465,739

Title:	Stable aqueous pharmaceutical formulations of daclizumab antibodies
Abstract:	This invention is directed to a stable liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg/ml or more, of antibody in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, having pH from about pH 5.5 to about pH 6.5, about 0.01-0.1% polysorbate, and a tonicity modifier that contributes to the isotonicity of the formulation. This liquid formulation is stable at refrigerated temperature (2-8.degree. C.) for at least 1 year, and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. The preferred antibodies include Daclizumab, a humanized anti-IL-2 receptor monoclonal antibody; HAIL-12, a humanized anti-IL-12 monoclonal antibody; HuEP5C7, a humanized anti-L selectin monoclonal antibody; and Flintozumab, a humanized anti-gamma interferon monoclonal antibody.
Inventor(s):	Kaisheva; Elizabet A. (Belmont, CA), Gupta; Supriya (Sunnyvale, CA), Duvur; Shanti G. (Fremont, CA), Subramanian; Malathy (Fremont, CA)
Assignee:	Abbvie Biotherapeutics Inc. (Redwood City, CA)
Application Number:	13/226,372
Patent Claims:	1. A stable aqueous pharmaceutical formulation, comprising: about 20 mM to about 60 mM succinate buffer, about 0.01% to about 0.1% polysorbate, about 75 mM to about 150 mM sodium chloride, and at least about 100 mg/ml of a daclizumab antibody, wherein said aqueous pharmaceutical formulation has a pH in the range of about pH 5.5 to about pH 6.5; and wherein the daclizumab in said aqueous pharmaceutical formulation shows no more than 10% aggregation after 3 months at room temperature as measured by size exclusion chromatography. 2. The stable aqueous pharmaceutical formulation of claim 1 in which the polysorbate is polysorbate 80. 3. The stable aqueous pharmaceutical formulation of claim 1 in which the succinate buffer is sodium succinate. 4. The stable aqueous pharmaceutical formulation of claim 1 which has a pH of about pH 6.0. 5. The stable aqueous pharmaceutical of claim 1, in which the amount of polysorbate is about 0.01% to about 0.05%. 6. The stable aqueous pharmaceutical of claim 1, in which the amount of polysorbate is about 0.02% to about 0.04%. 7. The stable aqueous pharmaceutical formulation of claim 1, wherein the daclizumab in said aqueous pharmaceutical formulation shows no more than 5% aggregation after 3 months at room temperature as measured by size exclusion chromatography. 8. The stable aqueous pharmaceutical formulation of claim 1, wherein the daclizumab in said aqueous pharmaceutical formulation shows no more than 10% aggregation after 6 months at room temperature as measured by size exclusion chromatography. 9. The stable aqueous pharmaceutical formulation of claim 1, wherein the daclizumab in said aqueous pharmaceutical formulation shows no more than 5% aggregation after 6 months at room temperature as measured by size exclusion chromatography.

Details for Patent 8,465,739

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2021-11-08
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2021-11-08
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2021-11-08