Claims for Patent: 9,533,044

Summary for Patent: 9,533,044

Title:	Methods of treating inflammatory disorders using high concentration natalizumab compositions
Abstract:	Formulations of VLA-4 binding antibody are described.
Inventor(s):	Maloney; Kevin (Nashua, NH)
Assignee:	BIOGEN MA INC. (Cambridge, MA)
Application Number:	13/530,879
Patent Claims:	1. A method of treatment of a patient with an inflammatory disorder, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of a stable aqueous composition comprising 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5. 2. The method of claim 1, wherein the composition has a viscosity of 5-30 cP at ambient temperature. 3. The method of claim 1, wherein the composition is stable for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 4. The method of claim 1, wherein the composition is stable for at least 24 months at a temperature of about 2.degree. C. to about 8.degree. C. 5. The method of claim 1, wherein the composition shows less than 10% aggregation following storage for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 6. The method of claim 1, wherein the composition shows less than 10% aggregation following storage for 18 months at a temperature of about 2.degree. C. to about 8.degree. C. 7. The method of claim 1, wherein the method comprises administering 1 mL of the composition. 8. The method of claim 1, wherein the inflammatory disorder is multiple sclerosis. 9. The method of claim 1, wherein the composition is administered subcutaneously. 10. The method of claim 1, wherein the composition comprises sodium phosphate monobasic, monohydrate or sodium phosphate dibasic heptahydrate or both. 11. The method of claim 1, wherein the composition retains its biological activity after storage of the composition for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 12. The method of claim 1, wherein the composition has a potency of at least 97% at 25.degree. C. after storage for 12 months at a temperature of 5.degree. C. 13. The method of claim 1, wherein the inflammatory disorder is asthma. 14. The method of claim 1, wherein the inflammatory disorder is an arthritic disorder. 15. The method of claim 1, wherein the inflammatory disorder is diabetes. 16. The method of claim 1, wherein the inflammatory disorder is a fibrotic disorder. 17. The method of claim 1, wherein the inflammatory disorder is an inflammatory bowel disease. 18. The method of claim 1, wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition. 19. A method of treatment of a patient with an inflammatory disorder, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of a stable aqueous composition consisting essentially of 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5. 20. The method of claim 19, wherein the composition has a viscosity of 5-30 cP at ambient temperature. 21. The method of claim 19, wherein the composition is stable for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 22. The method of claim 19, wherein the composition is stable for at least 24 months at a temperature of about 2.degree. C. to about 8.degree. C. 23. The method of claim 19, wherein the composition shows less than 10% aggregation following storage for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 24. The method of claim 19, wherein the composition shows less than 10% aggregation following storage for 18 months at a temperature of about 2.degree. C. to about 8.degree. C. 25. The method of claim 19, wherein the method comprises administering 1 mL of the composition. 26. The method of claim 19, wherein the inflammatory disorder is multiple sclerosis. 27. The method of claim 19, wherein the composition retains its biological activity after storage of the composition for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 28. The method of claim 19, wherein the composition has a potency of at least 97% at 25.degree. C. after storage for 12 months at a temperature of 5.degree. C. 29. The method of claim 19, wherein the inflammatory disorder is an inflammatory bowel disease. 30. The method of claim 19, wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition. 31. A method of treatment of a patient with an inflammatory disorder, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of a stable aqueous composition consisting of 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5. 32. The method of claim 31, wherein the composition has a viscosity of 5-30 cP at ambient temperature. 33. The method of claim 31, wherein the composition is stable for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 34. The method of claim 31, wherein the composition is stable for at least 24 months at a temperature of about 2.degree. C. to about 8.degree. C. 35. The method of claim 31, wherein the composition shows less than 10% aggregation following storage for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 36. The method of claim 31, wherein the composition shows less than 10% aggregation following storage for 18 months at a temperature of about 2.degree. C. to about 8.degree. C. 37. The method of claim 31, wherein the method comprises administering 1 mL of the composition. 38. The method of claim 31, wherein the inflammatory disorder is multiple sclerosis. 39. The method of claim 31, wherein the composition retains its biological activity after storage of the composition for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 40. The method of claim 31, wherein the composition has a potency of at least 97% at 25.degree. C. after storage for 12 months at a temperature of 5.degree. C. 41. The method of claim 31, wherein the inflammatory disorder is an inflammatory bowel disease. 42. The method of claim 31, wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition. 43. A method of treatment of a patient with multiple sclerosis, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of an aqueous composition comprising 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5, wherein the composition has a viscosity of 5-30 cP at ambient temperature and shows less than 10% aggregation after storage for at least 12 months at a temperature of about 2.degree. C. to about 8.degree. C. 44. The method of claim 43, wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition.

Details for Patent 9,533,044

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2027-06-14