Claims for Patent: 8,815,236

Summary for Patent: 8,815,236

Title:	Method for treating multiple sclerosis and crohn\'s disease
Abstract:	A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which maintain fixed volumes and which may be used on patients of variable weight.
Inventor(s):	Burke; David J. (Oakland, CA), Buckley; Shaun E. (San Francisco, CA), Lehrman; Sherwood Russ (Los Altos, CA), O\'Connor; Barbara Horsey (San Carlos, CA), Callaway; James (San Diego, CA), Phillips; Christopher P. (Doyleston, PA)
Assignee:	Biogen Idec MA Inc. (Cambridge, MA)
Application Number:	13/676,866
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,815,236
Patent Claims:	1. A method of treatment, comprising administering to a patient with multiple sclerosis a therapeutic amount of a stable, aqueous pharmaceutical formulation comprising from about 20 mg/ml to about 150 mg/ml of natalizumab, about 10 mM phosphate buffer, about 140 mM sodium chloride, and polysorbate 80 present in an amount of about 0.001% to 2% (w/v), wherein the multiple sclerosis is treated by administration of the stable, aqueous pharmaceutical formulation. 2. The method of claim 1, wherein the pharmaceutical formulation is administered to the patient by intravenous administration. 3. The method of 2, wherein the pharmaceutical formulation is administered to the patient over a series of treatments. 4. The method of claim 1, wherein natalizumab is present in an amount of about 20 mg/mL. 5. The method of claim 1, wherein the polysorbate 80 is present an amount of about 0.02% (w/v). 6. The method of claim 1, wherein the formulation has a pH of about 3.0 to about 7.0. 7. The method of claim 6, wherein the pH is about 5.5 to about 6.5. 8. The method of claim 6, wherein the pH is about 6.0 .+-.0.5. 9. A method treatment, comprising administering to a patient with Crohn's disease a therapeutic amount of a stable, aqueous pharmaceutical formulation comprising from about 20 mg/ml to about 150 mg/ml of natalizumab, about 10 mM phosphate buffer, about 140 mM sodium chloride, and polysorbate 80 present in an amount of about 0.001% to 2% (w/v), wherein the Crohn's disease is treated by administration of the stable, aqueous pharmaceutical formulation. 10. The method of claim 9, wherein the pharmaceutical formulation is administered to the patient by intravenous administration. 11. The method of 10, wherein the pharmaceutical formulation is administered to the patient over a series of treatments. 12. The method of claim 9, wherein natalizumab is present in an amount of about 20 mg/mL. 13. The method of claim 9, wherein the polysorbate 80 is present an amount of about 0.02% (w/v). 14. The method of claim 9, wherein the formulation has a pH of about 3.0 to about 7.0. 15. The method of claim 14, wherein the pH is about 5.5 to about 6.5. 16. The method of claim 15, wherein the pH is about 6.0 .+-.0.5. 17. The method of claim 1, wherein natalizumab is present in an amount of about 150 mg/mL. 18. The method of claim 9, wherein the pharmaceutical formulation is administered to the patient by subcutaneous administration. 19. The method of claim 17, wherein natalizumab is present in an amount of about 150 mg/mL. 20. The method of claim 19, wherein the pharmaceutical formulation is administered to the patient by subcutaneous administration. 21. A method of treatment, comprising intravenously administering to a patient with multiple sclerosis a therapeutic amount of a stable, aqueous pharmaceutical formulation comprising 20 mg/ml natalizumab, about 10 mM phosphate buffer, 8.18 mg/mL of sodium chloride, and 0.2 mg/mL of polysorbate 80, wherein the formulation has a pH of 6.1, and wherein the multiple sclerosis is treated by administration of the stable, aqueous pharmaceutical formulation. 22. A method of treatment, comprising intravenously administering to a patient with Crohn's disease a therapeutic amount of a stable, aqueous pharmaceutical formulation comprising 20 mg/ml natalizumab, about 10 mM phosphate buffer, 8.18 mg/mL of sodium chloride, and 0.2 mg/mL of polysorbate 80, wherein the formulation has a pH of 6.1, and wherein the Crohn's disease is treated by administration of the stable, aqueous pharmaceutical formulation.

Details for Patent 8,815,236

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2023-02-10