# US 9,518,111 B2 · Compositions comprising a p75 tumor necrosis factor receptor/Ig fusion protein

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- Number: US 9,518,111 B2
- Document ID: US9518111B2
- Status: Granted
- Kind: B2
- Application number: 14/478,926
- Filed: 2014-09-05
- Published: 2014-12-25
- Granted: 2016-12-13
- Earliest claimed: 2002-02-27
- Assignees: Immunex Corporation
- Applicants: Immunex Corporation
- Inventors: Wayne Richard Gombotz; Richard L. Remmele, Jr.
- Web page: https://patentgrep.com/patent/US9518111B2

## CPC

- C07K 14/70578: {NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95 (NGF-receptor C07K14/71, TNF-receptor C07K14/7151)}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 38/1793: {for cytokines; for lymphokines; for interferons}
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- 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 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- C07K 16/18: against material from animals or humans
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- Y10S 435/81: Packaged device or kit
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

The present invention relates to pharmaceutical compositions comprising a p75 tumor necrosis factor receptor/Ig fusion protein.

## Claims

### Claim 1

A pharmaceutical composition comprising a polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1 and from about 10 mM to about 200 mM L-arginine.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the composition is in a liquid state.

### Claim 3 (depends on 2)

The pharmaceutical composition of claim 2, wherein the composition is in a pre-filled sterile syringe.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, further comprising a buffer.

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4, wherein the buffer is selected from the group consisting of sodium phosphate, histidine, potassium phosphate, sodium citrate, potassium citrate, maleic acid, ammonium acetate, tris-(hydroxymethyl)-aminomethane (tris), acetate and diethanolamine.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, further comprising a tonicity modifier.

### Claim 7 (depends on 6)

The pharmaceutical composition of claim 6, wherein the tonicity modifier is selected from the group consisting of arginine, cysteine, histidine, glycine, sodium chloride, potassium chloride, sodium citrate, sucrose, glucose and mannitol.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein the tonicity modifier is sodium chloride.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, further comprising an excipient.

### Claim 10 (depends on 7)

The pharmaceutical composition of claim 7, further comprising an excipient.

### Claim 11 (depends on 9)

The pharmaceutical composition of claim 9, wherein the excipient is selected from the group consisting of sucrose, lactose, glycerol, xylitol, sorbitol, Mannitol, maltose, inositol, trehalose, glucose, bovine serum albumin (BSA), human SA or recombinant HA, dextran, PVA, hydroxypropyl methylcellulose (HPMC), polyethyleneimine, gelatin, polyvinylpyrrolidone (PVP), hydroxyethylcellulose (HEC), polyethylene glycol, ethylene glycol, glycerol, dimethysulfoxide (DMSO), dimethylformamide (DMF), proline, L-serine, sodium glutamic acid, alanine, glycine, lysine hydrochloride, sarcosine, gamma-aminobutyric acid, polysorbate-20, polysorbate-80, SDS, polysorbate, polyoxyethylene copolymer, potassium phosphate, sodium acetate, ammonium sulfate, magnesium sulfate, sodium sulfate, trimethylamine N-oxide, betaine, zinc ions, copper ions, calcium ions, manganese ions, magnesium ions, CHAPS, sucrose monolaurate, and 2-O-beta-mannoglycerate.

### Claim 12 (depends on 11)

The pharmaceutical composition of claim 11, wherein the excipient is sucrose.

### Claim 13

A pharmaceutical composition comprising about 10 mg/ml to about 100 mg/ml of a polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1, about 10 mM to about 200 mM L-arginine, and sodium phosphate, sodium chloride and sucrose.

### Claim 14 (depends on 13)

The pharmaceutical composition of claim 13, wherein the L-arginine is at about 10 mM to about 75 mM.

### Claim 15 (depends on 13)

The pharmaceutical composition of claim 13, wherein the sodium phosphate is at about 5 mM to about 100 mM.

### Claim 16 (depends on 13)

The pharmaceutical composition of claim 13, wherein the sucrose is at about 0.5% to about 1.5%.

### Claim 17 (depends on 13)

The pharmaceutical composition of claim 13, wherein the pH is about 5.5 to about 7.8.

### Claim 18 (depends on 13)

The pharmaceutical composition of claim 13, having about 50 mg/ml of the polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1, about 25 mM L-arginine, about 25 mM sodium phosphate, about 98 mM sodium chloride, about 1% sucrose, and wherein the composition is about pH 6.2.

### Claim 19 (depends on 1)

The pharmaceutical composition of claim 1, wherein the polypeptide is etanercept.

### Claim 20 (depends on 4)

The pharmaceutical composition of claim 4, wherein the polypeptide is etanercept.

### Claim 21 (depends on 6)

The pharmaceutical composition of claim 6, wherein the polypeptide is etanercept.

### Claim 22 (depends on 9)

The pharmaceutical composition of claim 9, wherein the polypeptide is etanercept.

### Claim 23 (depends on 13)

The pharmaceutical composition of claim 13, wherein the polypeptide is etanercept.