IP Library Granted Patent US 8,465,735
Granted Patent B2
US 8,465,735 · App. 13/623,512 · Granted Jun 18, 2013

Variant form of urate oxidase and use thereof

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Quick Facts
Patent No.
US 8,465,735
App. No.
13/623,512
Granted
Jun 18, 2013
Kind
B2
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 (28)

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.

2. The method of claim 1 , wherein said dosage is between 4 and 8 mg of uricase.

3. The method of claim 1 , wherein said dosage is between 8 and 12 mg of uricase.

4. The method of claim 1 , wherein said dosage is about 4 mg of uricase.

5. The method of claim 1 , wherein said dosage is about 8 mg of uricase.

6. The method of claim 1 , wherein said dosage is about 12 mg of uricase.

7. The method of claim 2 , wherein the about 4 mg of uricase is administered every two weeks.

8. The method of claim 5 , wherein the about 8 mg of uricase is administered every two weeks.

9. The method of claim 5 , wherein the about 8 mg of uricase is administered every four weeks.

10. The method of claim 6 , wherein about 12 mg of uricase is administered every four weeks.

11. The method of claim 1 , wherein the uric acid levels are lowered to 6.8 mg/dL or less.

12. The method of claim 11 , wherein the uric acid levels are lowered to 6 mg/dL or less.

13. The method of claim 1 , wherein said patient is suffering from hyperuricemia, gout or hyperuricemia and gout.

14. 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.

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.

16. The method of claim 15 , wherein said dosage is between 4 and 8 mg of uricase.

17. The method of claim 15 , wherein said dosage is between 8 and 12 mg of uricase.

18. The method of claim 15 , wherein said dosage is about 4 mg of uricase.

19. The method of claim 15 , wherein said dosage is about 8 mg of uricase.

20. The method of claim 15 , wherein said dosage is about 12 mg of uricase.

21. The method of claim 18 , wherein the about 4 mg of uricase is administered every two weeks.

22. The method of claim 19 , wherein the about 8 mg of uricase is administered every two weeks.

23. The method of claim 19 , wherein the about 8 mg of uricase is administered every four weeks.

24. The method of claim 20 , wherein about 12 mg of uricase is administered every four weeks.

25. The method of claim 15 , wherein the uric acid levels are lowered to 6.8 mg/dL or less.

26. The method of claim 25 , wherein the uric acid levels are lowered to 6 mg/dL or less.

27. The method of claim 15 , wherein said patient is suffering from hyperuricemia, gout or hyperuricemia and gout.

28. 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.

Assignments (13)
RELEASE OF SECURITY INTEREST Recorded Oct 6, 2023
From: CITIBANK, N.A.
To: HORIZON THERAPEUTICS USA, INC.
Reel/Frame 065178/0965 →
CORRECTIVE ASSIGNMENT TO CORRECT THE SELLER'S NAME AND EXECUTION DATE PREVIOUSLY RECORDED ON REEL 032675 FRAME 0936. ASSIGNOR(S) HEREBY CONFIRMS THE SELLER'S NAME SHOULD READ SAVIENT PHARMA HOLDINGS, INC. AND THE EXECUTION DATE FOR BOTH PARTIES SHOULD READ 01/09/2014. Recorded Jun 16, 2023
From: SAVIENT PHARMACEUTICALS, INC.; SAVIENT PHARMA HOLDINGS, INC.
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 064009/0261 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2022
From: HARTMAN, JACOB; MENDELOVITZ, SIMONA
To: SAVIENT PHARMACEUTICALS, INC.
Reel/Frame 062191/0611 →
CORRECTIVE ASSIGNMENT TO CORRECT THE NAME OF THE ASSIGNEE PREVIOUSLY RECORDED ON REEL 061805 FRAME 0076. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Dec 1, 2022
From: HORIZON PHARMA RHEUMATOLOGY LLC
To: HORIZON THERAPEUTICS USA, INC.
Reel/Frame 062073/0930 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2022
From: HORIZON PHARMA RHEUMATOLOGY LLC
To: HORIZON THERAPEUTICS USA, INC
Reel/Frame 061805/0076 →
CHANGE OF NAME Recorded Nov 18, 2016
From: CREALTA PHARMACEUTICALS LLC
To: HORIZON PHARMA USA RHEUMATOLOGY LLC
Reel/Frame 040648/0361 →
CHANGE OF NAME Recorded Nov 18, 2016
From: HORIZON PHARMA USA RHEUMATOLOGY LLC
To: HORIZON PHARMA RHEUMATOLOGY LLC
Reel/Frame 040648/0367 →
PATENT SECURITY AGREEMENT Recorded Sep 16, 2016
From: HORIZON PHARMA RHEUMATOLOGY LLC (FORMERLY KNOWN AS CREALTA PHARMACEUTICALS LLC)
To: CITIBANK, N.A., AS COLLATERAL AGENT
Reel/Frame 040059/0007 →
RELEASE OF SECURITY INTEREST Recorded Jan 13, 2016
From: FIFTH STREET FINANCE CORP., AS COLLATERAL AGENT
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 037483/0049 →
RELEASE OF SECURITY INTEREST Recorded Jan 13, 2016
From: JEFFERIES FINANCE LLC, AS COLLATERAL AGENT
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 037483/0148 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2014
From: SAVIENT PHARMACEUTICALS, INC.; SAVIENT PHARMA HOLDINGS, LLC
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 032675/0936 →
SECURITY AGREEMENT Recorded Mar 4, 2014
From: CREALTA PHARMACEUTICALS LLC
To: FIFTH STREET FINANCE CORP., AS COLLATERAL AGENT
Reel/Frame 032384/0285 →
SECURITY AGREEMENT Recorded Feb 21, 2014
From: CREALTA PHARMACEUTICALS LLC
To: JEFFERIES FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 032319/0077 →