Claims for Patent: 9,662,396

Summary for Patent: 9,662,396

Title:	Stable aqueous formulations of etanercept
Abstract:	The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.
Inventor(s):	Manning; Mark (Johnstown, CO), Murphy; Brian (Fort Collins, CO)
Assignee:	Coherus Biosciences, Inc. (Redwood City, CA)
Application Number:	14/592,654
Patent Claims:	1. A stabilized aqueous pharmaceutical composition having long term storage stability, comprising: etanercept and a stabilizer to inhibit instability, aggregation and/or fragmentation of the etanercept, wherein the composition is free of arginine as a stabilizer and wherein the stabilizer is 1 mM to 20 mM magnesium chloride. 2. The stabilized composition of claim 1 characterized by: (a) an SEC (size exclusion chromatography) analysis at T.sub.4 of greater than 90, 91, 92, 93, 94, 95, 96, or 97 wt. % monomer content; and less than 3, 2 or 1 wt. % aggregate(s) content; and (b) an HIC (hydrophobic interaction chromatography) analysis at T.sub.2 wherein the amount of the composition represented by peak 1 of the HIC chromatogram is less than 3, 2 or 1 wt. %; the amount of the composition represented by peak 2 of the HIC chromatogram is greater than 80, 81, 82, 83, 84 or 85 wt. %; and the amount of the composition represented by peak 3 of the HIC chromatogram is less than 20, 19, 18, 17, 16, 15, 14, or 13 wt. %; and (c) an HIC analysis at T.sub.4 wherein the amount of the composition represented by peak 1 of the HIC chromatogram is less than 3, 2 or 1 wt. %; the amount of the composition represented by peak 2 of the HIC chromatogram is greater than 80, 81, 82, 83, 84 or 85 wt. %; and the amount of the composition represented by peak 3 of the HIC chromatogram is less than 20, 19, 18, 17, 16, 15, 14 or 13 wt. %. 3. The stabilized composition of claim 2 having an HIC analysis at T.sub.4 or T.sub.2 wherein the amount of the composition represented by peak 1 of the HIC chromatogram is less than 2 wt. %; the amount of the composition represented by peak 2 of the HIC chromatogram is greater than 85 wt. %; and the amount of the composition represented by peak 3 of the HIC chromatogram is less than 13 wt. %. 4. The stabilized composition of claim 1 wherein the composition comprises 25 to 50 mg/ml of etanercept; optionally up to 6 wt. % sucrose; 25 to 150 mM NaCl; and 1 to 30 mM sodium phosphate and wherein the composition has a pH of 6.0 to pH 7.0.

Details for Patent 9,662,396

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2039-02-26