Claims for Patent: 8,460,663

Summary for Patent: 8,460,663

Title:	Stabilized liquid anti-RSV antibody formulations
Abstract:	The present invention provides liquid formulations of SYNAGIS.RTM. or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS.RTM. or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS.RTM. or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.
Inventor(s):	Oliver; Cynthia N. (North Potomac, MD), Shane; Erica (McLean, VA), Isaacs; Benjamin S. (Andover, MA), Allan; Christian B. (Brookeville, MD), Chang; Stephen T. (Frederick, MD)
Assignee:	MedImmune, LLC (Gaithersburg, MD)
Application Number:	13/481,640
Patent Claims:	1. A method for preventing a symptom of a respiratory syncytial virus (RSV) infection, comprising administering intramuscularly to a human infant 15 mg/kg of an aqueous palivizumab formulation comprising, in distilled water: (a) 103.+-.3 mg/ml of palivizumab or an antigen-binding fragment thereof; (b) histidine at a concentration of about 25 mM, and (c) glycine at a concentration of about 1.6 mM, wherein the palivizumab or palivizumab antigen-binding fragment in the formulation is stable at 2.degree. C. to 8.degree. C. for 15 months as determined by high performance size exclusion chromatography (HPSEC) and the formulation has a pH of about 6.0. 2. A method for preventing a symptom of a respiratory syncytial virus (RSV) infection, comprising administering intramuscularly to a human infant 15 mg/kg of an aqueous palivizumab formulation comprising, in distilled water: (a) about 100 mg/ml of palivizumab or an antigen-binding fragment thereof; (b) histidine at a concentration of about 25 mM, and (c) glycine at a concentration of about 1.6 mM, wherein the palivizumab or palivizumab antigen-binding fragment in the formulation is stable at 38.degree. C. to 42.degree. C. for at least 60 days as determined by HPSEC. 3. The method of claim 1 or 2, wherein the formulation is substantially free of surfactants and inorganic salts. 4. The method of claim 1 or 2, wherein the formulation is substantially free of surfactants, inorganic salts and other excipients. 5. The method of claim 1 or 2, wherein the formulation does not contain mannitol. 6. The method of claim 1 or 2, herein the palivizumab or palivizumab antigen-binding fragment in the formulation is stable at 20.degree. C. to 24.degree. C. for at least 1 year as determined by HPSEC. 7. The method of claim 1, wherein the palivizumab or palivizumab antigen-binding fragment in the formulation is stable at 38.degree. C. to 42.degree. C. for at least 60 days as determined by HPSEC. 8. The method of claim 2 or 7, wherein the palivizumab or palivizumab antigen-binding fragment in the formulation is stable at 38.degree. C. to 42.degree. C. for no more than 120 days as determined by HPSEC. 9. The method of claim 1 or 2, wherein the palivizumab or palivizumab antigen-binding fragment in the formulation is stable at 2.degree. C. to 8.degree. C. for at least 3 year as determined by HPSEC. 10. The method of claim 1 or 2, wherein the aqueous palivizumab formulation contains no more than 3% aggregation by weight protein as measured by HPSEC. 11. The method of claim 1 or 2, wherein the stable aqueous palivizumab formulation contains equal to or more than 98% of the total protein in a single peak as determined by HPSEC and contains no other single peaks having more than 2% of total protein each. 12. The method of claim 1 or 2, wherein the human infant is at high risk for hospitalization for a RSV infection. 13. The method of claim 1 or 2, wherein the human infant has bronchopulmonary dysplasia or a congenital heart disease. 14. The method of claim 1 or 2, wherein the aqueous palivizumab formulation is administered once prior to the RSV season. 15. The method of claim 1 or 2, wherein the aqueous palivizumab formulation is administered once a month during the RSV season.

Details for Patent 8,460,663

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	06/19/1998		2022-06-14
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	Injection	103770	07/23/2004		2022-06-14