Granted Patent
B2
US 12,485,173 · App. 19/088,722 · Granted Dec 2, 2025
Pharmaceutical products and stable liquid compositions of IL-17 antibodies
Assignee:
NOVARTIS AG
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Abstract
The disclosure is directed to pharmaceutical products and stable liquid compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making these pharmaceutical products and compositions. The disclosure is also directed to the use of these pharmaceutical products and liquid compositions (e.g., as part of a kit having instructions for use) for the treatment of various IL-17-mediated disorders (e.g., autoimmune disorders, such as psoriasis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis).
Claims (46)
1 . A liquid pharmaceutical composition comprising:
(a) about 150 mg/mL secukinumab; and
(b) about 2.5 mM to about 134 mM methionine;
wherein the composition has a pH of about 5.2 to about 6.2; and
wherein upon storage at 2-8° C. for about 24 months:
(i) no more than 10% of secukinumab monomer is degraded as measured by size exclusion chromatography (SEC);
(ii) no more than 10% of secukinumab main variant is degraded as measured by cation exchange chromatography (CEX); or
(ii) no more than 10% of secukinumab main variant is degraded as measured by reverse phase-high performance liquid chromatography (RP-HPLC).
2 . The composition of claim 1 , wherein the methionine is at a concentration of from about 10 mM to about 67 mM.
3 . The composition of claim 1 , wherein the composition comprises gluconate, histidine, citrate, phosphate, succinate, acetate, Tris, glycine, or arginine.
4 . The composition of claim 3 , wherein the composition comprises a non-ionic stabilizer or an ionic stabilizer.
5 . The composition of claim 4 , wherein the stabilizer comprises mannitol, trehalose, raffinose, maltose, or sorbitol.
6 . The composition of claim 4 , wherein the stabilizer comprises sodium chloride, glycine, or arginine.
7 . The composition of claim 5 , wherein the stabilizer comprises glycine or arginine.
8 . The composition of claim 7 , wherein glycine is at a concentration of about 270 mM.
9 . The composition of claim 7 , wherein arginine is at a concentration of about 160 mM.
10 . The composition of claim 1 , wherein the composition comprises a non-ionic stabilizer or an ionic stabilizer.
11 . The composition of claim 10 , wherein the stabilizer comprises mannitol, trehalose, raffinose, maltose, or sorbitol.
12 . The composition of claim 10 , wherein the stabilizer comprises sodium chloride, glycine, or arginine.
13 . The composition of claim 12 , wherein the stabilizer comprises glycine or arginine.
14 . The composition of claim 13 , wherein glycine is at a concentration of about 270 mM.
15 . The composition of claim 13 , wherein arginine is at a concentration of about 160 mM.
16 . The composition of claim 1 , wherein the composition comprises a surfactant.
17 . The composition of claim 16 , wherein the surfactant is polysorbate, poloxamer, or a combination thereof.
18 . The composition of claim 17 , wherein the surfactant is polysorbate 20 or polysorbate 80.
19 . The composition of claim 18 , wherein the surfactant is polysorbate 80.
20 . The composition of claim 18 , wherein the surfactant is at a concentration of about 0.01% (w/v) to about 0.04% (w/V).
21 . The composition of claim 4 , wherein the composition comprises a surfactant.
22 . The composition of claim 21 , wherein the surfactant is polysorbate, poloxamer, or a combination thereof.
23 . The composition of claim 22 , wherein the surfactant is polysorbate 20 or polysorbate 80.
24 . The composition of claim 23 , wherein the surfactant is polysorbate 80.
25 . The composition of claim 23 , wherein the surfactant is at a concentration of about 0.01% (w/v) to about 0.04% (w/V).
26 . The composition of claim 1 , wherein upon storage at 2-8° C. for about 24 months:
(a) no more than 10% of secukinumab monomer is degraded as measured by size exclusion chromatography (SEC);
(b) no more than 10% of secukinumab main variant is degraded as measured by cation exchange chromatography (CEX); and
(c) no more than 10% of secukinumab main variant is degraded as measured by reverse phase-high performance liquid chromatography (RP-HPLC).
27 . The composition of claim 1 , wherein upon storage at 25° C. for about 6 months:
(a) no more than 10% of secukinumab monomer is degraded as measured by size exclusion chromatography (SEC);
(b) no more than 10% of secukinumab main variant is degraded as measured by cation exchange chromatography (CEX); or
(c) no more than 10% of secukinumab main variant is degraded as measured by reverse phase-high performance liquid chromatography (RP-HPLC).
28 . The composition of claim 1 , wherein upon storage at 25° C. for about 6 months:
(a) no more than 10% of secukinumab monomer is degraded as measured by size exclusion chromatography (SEC);
(b) no more than 10% of secukinumab main variant is degraded as measured by cation exchange chromatography (CEX); and
(c) no more than 10% of secukinumab main variant is degraded as measured by reverse phase-high performance liquid chromatography (RP-HPLC).
29 . A pharmaceutical product comprising a container with a headspace and the composition of claim 1 disposed within the container, wherein the oxygen content in the headspace is at or less than 12%.
30 . The composition of claim 1 , wherein the secukinumab has at least 2.0 mol free thiol (SH) per mol secukinumab upon storage at 2-8° C. for about 24 months.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 11, 2026
From: NOVARTIS AG
To: NOVARTIS PHARMA AG
Reel/Frame 075712/0291 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 13, 2025
From: SERNO-SCHERSCH, KATHRIN
To: NOVARTIS PHARMA AG
Reel/Frame 072892/0004 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 13, 2025
From: NOVARTIS PHARMA AG
To: NOVARTIS AG
Reel/Frame 072892/0021 →
Continuity (4)
Division
15538257
Provisional Application
62095210
· Dec 22, 2014
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