Claims for Patent: 8,476,239

Summary for Patent: 8,476,239

Title:	Stable protein formulations
Abstract:	The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.
Inventor(s):	Dali; Manisha M. (Bridgewater, NJ), Dahlheim; Charles E. (Lawrenceville, NJ), Borsadia; Sunita (Plainsboro, NJ), Naringrekar; Vijay H. (Princeton, NJ), Gandhi; Rajesh Babulal (Plainsboro, NJ), Nerurkar; Manoj (Mumbai, IN)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	12/086,876
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,476,239
Patent Claims:	1. A stable formulation suitable for subcutaneous administration comprising at least 100mg/ml CTLA4Ig molecule, a sugar selected from the group consisting of sucrose, lactose, maltose, mannitol and trehalose and mixtures thereof and a pharmaceutically acceptable aqueous carrier, wherein the formulation has a pH range of from 6 to 8 and a viscosity of from 9 to 20 cps, and the weight ratio of sugar:protein is 1.1:1 or higher. 2. The formulation of claim 1 wherein the sugar is selected from the group consisting of sucrose, mannitol or trehalose. 3. The formulation of claim 1 further comprising a pharmaceutically acceptable buffer. 4. The formulation of claim 1 wherein the CTLA4Ig molecule has the amino acid sequence shown in SEQ ID NO:2 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382. 5. The formulation of claim 2 wherein the sugar is sucrose. 6. The formulation of claim 4 further comprising a pharmaceutically acceptable buffer. 7. A stable formulation comprising the CTLA4Ig molecule having the amino acid sequence shown in SEQ ID NO:2 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 125 mg/ml, sucrose in an amount of about 170 mg/ml, at least one buffering agent, sterile water for injection and optionally a surfactant. 8. The formulation of claim 3, 6 or 7 wherein the buffering agent is in an amount of at least 10 mM phosphate buffer. 9. The formulation of claim 7 wherein the surfactant is Poloxamer 188 in an amount of about 8 mg/ml. 10. The formulation of claim 7 having a pH range of from 6 to 8. 11. The formulation of claim 1, 4, or 7 wherein the formulation is stable when stored at 2 to 8 C for at least 12 months. 12. An article of manufacture comprising: a) at least one container which holds the formulation of claim 1, 4, or 7 and b) instructions for administering the formulation subcutaneously to a subject in need thereof. 13. The article of manufacture of claim 12 wherein the container is a vial or syringe. 14. The formulation of claim 5 wherein the weight ratio of sucrose:protein is 1.3:1 to 5:1. 15. The formulation of claim 5 wherein the weight ratio of sucrose:protein is 1.4:1.

Details for Patent 8,476,239

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2025-12-20