# US 8,465,735 B2 · Variant form of urate oxidase and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,465,735 B2 - Document ID: US8465735B2 - Status: Granted - Kind: B2 - Application number: 13/623,512 - Filed: 2012-09-20 - Published: 2013-04-04 - Granted: 2013-06-18 - Earliest claimed: 2005-04-11 - Assignees: Savient Pharmaceuticals, Inc. - Applicants: Savient Pharmaceuticals, Inc. - Inventors: Jacob Hartman; Simona Mendelovitz - Web page: https://patentgrep.com/patent/US8465735B2 ## CPC - A61K 38/44: Oxidoreductases (1) - A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol - A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C12N 9/0046: {with oxygen as acceptor (1.7.3)} - C12Y 107/03003: Factor-independent urate hydroxylase (1.7.3.3), i.e. uricase - 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 - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - C12Y: ENZYMES ## Abstract The present invention relates to genetically modified proteins with uricolytic activity. More specifically, the invention relates to proteins comprising truncated urate oxidases and methods for producing them, including PEGylated proteins comprising truncated urate oxidases. ## Claims ### Claim 1 A method for lowering elevated uric acid levels in a patient comprising administering to said patient an intravenous injection of PEG-uricase having a dosage from about 0.5 to about 24 mg of uricase, the uricase comprising the amino acid sequence of SEQ ID NO: 7, wherein said administration takes place from about every 2 to 4 weeks. ### Claim 2 (depends on 1) The method of claim 1, wherein said dosage is between 4 and 8 mg of uricase. ### Claim 3 (depends on 1) The method of claim 1, wherein said dosage is between 8 and 12 mg of uricase. ### Claim 4 (depends on 1) The method of claim 1, wherein said dosage is about 4 mg of uricase. ### Claim 5 (depends on 1) The method of claim 1, wherein said dosage is about 8 mg of uricase. ### Claim 6 (depends on 1) The method of claim 1, wherein said dosage is about 12 mg of uricase. ### Claim 7 (depends on 2) The method of claim 2, wherein the about 4 mg of uricase is administered every two weeks. ### Claim 8 (depends on 5) The method of claim 5, wherein the about 8 mg of uricase is administered every two weeks. ### Claim 9 (depends on 5) The method of claim 5, wherein the about 8 mg of uricase is administered every four weeks. ### Claim 10 (depends on 6) The method of claim 6, wherein about 12 mg of uricase is administered every four weeks. ### Claim 11 (depends on 1) The method of claim 1, wherein the uric acid levels are lowered to 6.8 mg/dL or less. ### Claim 12 (depends on 11) The method of claim 11, wherein the uric acid levels are lowered to 6 mg/dL or less. ### Claim 13 (depends on 1) The method of claim 1, wherein said patient is suffering from hyperuricemia, gout or hyperuricemia and gout. ### Claim 14 (depends on 1) The method of claim 1, wherein said patient has a plasma level of uric acid (PUA) of more than about 6 mg/dL before said administration. ### Claim 15 A method for lowering elevated uric acid levels in a patient comprising administering to said patient an intravenous injection of PEG-uricase having a dosage from about 4 to about 12 mg of uricase, the uricase consisting of the amino acid sequence of SEQ ID NO: 7, wherein the PEG-uricase administration takes place from about every 2 to 4 weeks. ### Claim 16 (depends on 15) The method of claim 15, wherein said dosage is between 4 and 8 mg of uricase. ### Claim 17 (depends on 15) The method of claim 15, wherein said dosage is between 8 and 12 mg of uricase. ### Claim 18 (depends on 15) The method of claim 15, wherein said dosage is about 4 mg of uricase. ### Claim 19 (depends on 15) The method of claim 15, wherein said dosage is about 8 mg of uricase. ### Claim 20 (depends on 15) The method of claim 15, wherein said dosage is about 12 mg of uricase. ### Claim 21 (depends on 18) The method of claim 18, wherein the about 4 mg of uricase is administered every two weeks. ### Claim 22 (depends on 19) The method of claim 19, wherein the about 8 mg of uricase is administered every two weeks. ### Claim 23 (depends on 19) The method of claim 19, wherein the about 8 mg of uricase is administered every four weeks. ### Claim 24 (depends on 20) The method of claim 20, wherein about 12 mg of uricase is administered every four weeks. ### Claim 25 (depends on 15) The method of claim 15, wherein the uric acid levels are lowered to 6.8 mg/dL or less. ### Claim 26 (depends on 25) The method of claim 25, wherein the uric acid levels are lowered to 6 mg/dL or less. ### Claim 27 (depends on 15) The method of claim 15, wherein said patient is suffering from hyperuricemia, gout or hyperuricemia and gout. ### Claim 28 (depends on 15) The method of claim 15, wherein said patient has a plasma level of uric acid (PUA) of more than about 6 mg/dL before said administration.