Claims for Patent: 9,925,262

Summary for Patent: 9,925,262

Title:	Kits comprising formulations of anti-C5 antibodies
Abstract:	The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment.
Inventor(s):	Zhou; Xiao-Hong (Madison, CT), Wang; Yi (Woodbridge, CT)
Assignee:	Alexion Pharmaceuticals, Inc. (New Haven, CT)
Application Number:	15/384,788
Patent Claims:	1. A kit for treating Paroxysmal Nocturnal Hemoglobinuria (PNH) in a human patient, the kit comprising: (a) a stable aqueous solution comprising an anti-C5 antibody at a concentration of about 100 mg/mL to about 200 mg/mL, about 20 mM histidine, about 50 mM serine, about 3% (w/v) sorbitol, about 1.5% (w/v) mannitol; and (b) instructions for use, wherein the anti-C5 antibody comprises CDR1, CDR2, and CDR3 domains of a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:13 and CDR1, CDR2, and CDR3 domains of a light chain comprising the amino acid sequence set forth in SEQ ID NO:12. 2. A kit for treating atypical hemolytic uremic syndrome (aHUS) in a human patient, the kit comprising: (a) a stable aqueous solution comprising an anti-C5 antibody at a concentration of about 100 mg/mL to about 200 mg/mL, about 20 mM histidine, about 50 mM serine, about 3% (w/v) sorbitol, about 1.5% (w/v) mannitol; and (b) instructions for use, wherein the anti-C5 antibody comprises CDR1, CDR2, and CDR3 domains of a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:13 and CDR1, CDR2, and CDR3 domains of a light chain comprising the amino acid sequence set forth in SEQ ID NO:12. 3. The kit of claim 1 or 2, wherein the anti-C5 antibody comprises a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:13 and a light chain comprising the amino acid sequence set forth in SEQ ID NO:12. 4. The kit of claim 1 or 2, wherein the anti-C5 antibody is eculizumab. 5. The kit of claim 1 or 2, wherein the pH of the solution is between 6.5 and 7.5. 6. The kit of claim 1 or 2, wherein the anti-C5 antibody is at a concentration of 100 mg/mL. 7. The kit of claim 1 or 2, wherein the anti-C5 antibody remains at least 97% monomeric during storage at 2.degree. C. to 8.degree. C. for at least six months as determined by SEC-HPLC. 8. The kit of claim 1 or 2, wherein the anti-C5 antibody remains at least 97% monomeric during storage at 2.degree. C. to 8.degree. C. for at least one year as determined by SEC-HPLC. 9. The kit of claim 1 or 2, wherein less than 2% of the anti-C5 antibody in the solution is aggregated as determined by SEC-HPLC. 10. The kit of claim 1 or 2, wherein less than 1% of the anti-C5 antibody in the solution is fragmented as determined by SEC-HPLC. 11. The kit of claim 1 or 2, wherein during storage at 2.degree. C. to 8.degree. C. for at least six months the anti-C5 antibody retains at least 90% of its C5-binding activity, as compared to a reference anti-C5 antibody corresponding to the anti-C5 antibody prior to storage. 12. The kit of claim 1 or 2, wherein during storage at 2.degree. C. to 8.degree. C. for at least six months the anti-C5 antibody retains at least 95% of its ability to inhibit hemolysis, as compared to a reference anti-C5 antibody corresponding to the anti-C5 antibody prior to storage. 13. A kit for treating PNH or aHUS in a human patient, the kit comprising: (a) a stable aqueous solution comprising eculizumab, about 20 mM histidine, about 50 mM serine, about 3% (w/v) sorbitol, about 1.5% (w/v) mannitol; and instructions for use.

Details for Patent 9,925,262

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	03/16/2007		2031-03-08