# US 10,479,828 B2 · Compositions comprising an anti-C5 antibody

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- Number: US 10,479,828 B2
- Document ID: US10479828B2
- Status: Granted
- Kind: B2
- Application number: 16/152,235
- Filed: 2018-10-04
- Published: 2019-03-28
- Granted: 2019-11-19
- Earliest claimed: 2005-05-11
- Assignees: Alexion Pharmaceuticals, Inc.
- Applicants: Alexion Pharmaceuticals, Inc.
- Inventors: Yi Wang
- Web page: https://patentgrep.com/patent/US10479828B2

## CPC

- C07K 16/18: against material from animals or humans
- A61P 9/14: Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 11/08: Bronchodilators
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/543: {intranasal}
- A61K 2039/544: {to the airways}
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The present application relates to methods and compositions employing an antibody that inhibits activation of the complement system and can be used to prevent or treat a pulmonary disease or condition.

## Claims

### Claim 1

A pharmaceutical composition comprising 30 mg/mL of an anti-C5 antibody, sodium phosphate at a concentration of 10 mM, sodium chloride at a concentration of 150 mM, and polysorbate 80 at a level of 0.001 to 0.02% by volume, wherein the anti-C5 antibody comprises a variable light chain CDR1 comprising amino acid residues 26-36 of SEQ ID NO:1, a variable light chain CDR2 comprising amino acid residues 52-58 of SEQ ID NO:1, a variable light chain CDR3 comprising amino acid residues 91-99 of SEQ ID NO:1, a variable heavy chain CDR1 comprising amino acid residues 152-161 of SEQ ID NO:1, a variable heavy chain CDR2 comprising amino acid residues 176-192 of SEQ ID NO:1, and a variable heavy chain CDR3 comprising amino acid residues 225-237 of SEQ ID NO:1, and wherein the pH of the composition is between pH 6 and pH 8.

### Claim 2

A pharmaceutical composition comprising 30 mg/mL of an anti-C5 antibody, sodium phosphate at a concentration of 10 mM, sodium chloride at a concentration of 150 mM, and polysorbate 80 at a level of 0.001 to 0.02% by volume, wherein the anti-C5 antibody comprises a heavy chain variable region comprising residue numbers 1-122 of SEQ ID NO: 2 and a light chain variable region comprising residue numbers 1-108 of SEQ ID NO: 3, and wherein the pH of the composition is between pH 6 and pH 8.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition has physiologic osmolality.

### Claim 4 (depends on 2)

The pharmaceutical composition of claim 2, wherein the composition has physiologic osmolality.