Claims for Patent: 9,272,032

Summary for Patent: 9,272,032

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:	14/554,804
Patent Claims:	1. A method of preventing, treating or ameliorating one or more symptoms associated with a RSV infection in a subject, said method comprising administering a prophylactically or therapeutically effective amount of a liquid palivizumab formulation, said formulation comprising in an aqueous carrier: (a) at least 15 mg/ml of palivizumab, or an antigen-binding fragment thereof; and (b) histidine at a concentration of about 1 mM to about 100 mM, wherein said formulation is substantially free of surfactant, inorganic salts or other excipients. 2. The method of claim 1, wherein the formulation is administered parenterally. 3. The method of claim 1, wherein the formulation is administered intramuscularly. 4. The method of claim 1, wherein the formulation is administered intravenously. 5. The method of claim 1, wherein the formulation is administered subcutaneously. 6. The method of claim 1, wherein histidine is at concentration of about 10 to about 30 mM. 7. The method of claim 1, wherein the formulation has a pH of about 5.0 to about 7.0. 8. The method of claim 1, wherein the formulation further comprises glycine at a concentration of less than 3.0 mM. 9. The method of claim 1, the formulation having been prepared by a process in which, for each step of said process, said palivizumab or antigen-binding fragment thereof is in an aqueous phase at all times during preparation. 10. The method of claim 1, wherein the palivizumab or antigen-binding fragment thereof is not reconstituted lyophilized palivizumab or antigen-binding fragment thereof. 11. The method of claim 1, wherein the subject is an elderly human, a human with cystic fibrosis, a human with congenital immunodeficiency or acquired immunodeficiency, or a human who has had a bone marrow transplant. 12. The method of claim 1, wherein the subject is a human infant. 13. The method of claim 1, wherein the subject is a human infant born prematurely or a human infant at high risk for hospitalization for a RSV infection. 14. The method of claim 1, wherein the subject is a human with bronchopulmonary dysplasia or congenital heart disease. 15. The method of claim 1, wherein the formulation is administered to the subject at a dose of about 15 mg/kg to about 30 mg/kg. 16. The method of claim 1, further comprising the concurrent administration of one or more other therapeutic agents useful for the treatment, management or amelioration of one or more symptoms of a RSV infection. 17. The method of claim 16, wherein the one or more other therapeutic agent comprises an antibody other than palivizumab that immunospecifically binds to an RSV antigen. 18. The method of claim 1, wherein the formulation further comprises one or more other therapeutic agents useful for the treatment, management or amelioration of one or more symptoms of a RSV infection. 19. The method of claim 18, wherein the one or more other therapeutic agent comprises an antibody other than palivizumab that immunospecifically binds to an RSV antigen. 20. A method for preventing serious lower respiratory tract disease caused by RSV in pediatric patients, comprising administering to a pediatric patient an aqueous palivizumab formulation comprising in an aqueous carrier: (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 said formulation has a pH of about 6.0 and does not contain mannitol, and wherein said palivizumab or antigen-binding fragment thereof in the formulation is not reconstituted lyophilized palivizumab or antigen-binding fragment thereof. 21. The method of claim 20, wherein the formulation is administered parenterally. 22. The method of claim 20, wherein the formulation is administered intramuscularly. 23. The method of claim 20, wherein the formulation is administered intravenously. 24. The method of claim 20, wherein the formulation is administered subcutaneously. 25. The method of claim 20, the formulation having been prepared by a process in which, for each step of said process, said palivizumab or antigen-binding fragment thereof is in an aqueous phase at all times during preparation. 26. The method of claim 20, wherein the subject is a human infant. 27. The method of claim 20, wherein the subject is a human infant born prematurely or a human infant at high risk for hospitalization for a RSV infection. 28. The method of claim 20, wherein the subject is a human with bronchopulmonary dysplasia or congenital heart disease. 29. The method of claim 20, wherein the formulation is administered to the subject at a dose of about 15 mg/kg to about 30 mg/kg. 30. The method of claim 20, further comprising the concurrent administration of one or more other therapeutic agents useful for the treatment, management or amelioration of one or more symptoms of a RSV infection. 31. The method of claim 30, wherein the one or more other therapeutic agent comprises an antibody other than palivizumab that immunospecifically binds to an RSV antigen. 32. The method of claim 20, wherein the formulation further comprises one or more other therapeutic agents useful for the treatment, management or amelioration of one or more symptoms of a RSV infection. 33. The method of claim 32, wherein the one or more other therapeutic agent comprises an antibody other than palivizumab that immunospecifically binds to an RSV antigen.

Details for Patent 9,272,032

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