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Last Updated: March 29, 2024

Claims for Patent: 6,358,534


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Summary for Patent: 6,358,534
Title: Immunotolerant prothrombin complex preparation
Abstract:The invention relates to an immunotolerant prothrombin complex preparation, a method of producing this preparation, as well as the use of the preparation for producing a medicament,
Inventor(s): Schwarz; Hans-Peter (Vienna, AT), Turecek; Peter (Klosterneuburg, AT)
Assignee: Baxter Aktiengesellschaft (Vienna, AT)
Application Number:09/402,582
Patent Claims:1. An immunotolerant pharmaceutical prothrombin complex preparation comprising factors II, IX, and X, and comprising a factor VIII antigen content of less than 0.1 factor VIII:C antigen/U FEIBA, wherein said immunotolerant pharmaceutical prothrombin complex preparation does not include fibrinogen and heparin.

2. A pharmaceutical preparation as set forth in claim 1, further comprising factor VII.

3. A pharmaceutical preparation as set forth in claim 1, said preparation being produced from plasma or a plasma fraction.

4. A pharmaceutical preparation as set forth in claim 2, said preparation being produced from plasma or a plasma fraction.

5. A pharmaceutical preparation as set forth in claim 1, further comprising at least one of factors IXa, Xa and VIIa and having FEIB activity.

6. A pharmaceutical preparation as set forth in claim 2, further comprising at least one of factors IXa, Xa and VIIa and having FEIB activity.

7. A pharmaceutical preparation as set forth in claim 1, said preparation being free from phospholipids.

8. A pharmaceutical preparation as set forth in claim 2, said preparation being free from phospholipids.

9. A method for producing an immunotolerant pharmaceutical prothrombin complex preparation comprising factors II, IX, and X, and having a factor VIII antigen content of less than 0.1 factor VIII:C antigen/U FEIBA, wherein said immunotolerant pharmaceutical prothrombin complex preparation does not include fibrinogen and heparin, said method comprising the steps of:

(a) providing a plasma or plasma fraction comprising factors II, IX, and X,

(b) contacting said plasma or said plasma fraction with a carrier material so as to separate factor VIII from factors II, IX, and X,

(c) purifying said plasma or plasma fraction, and

(d) recovering a fraction comprising factors II, IX, and X.

10. A method as set forth in claim 9, wherein said contacting of said plasma or said plasma fraction with said carrier material is effected in the presence of a detergent.

11. A method as set forth in claim 9, wherein phospholipids are also separated when factor VIII is separated from said factors II, IX and X.

12. A method for producing an immunotolerant pharmaceutical prothrombin complex preparation comprising factors II, IX, X and VII, and having a factor VIII antigen content of less than 0.1 factor VIII:C antigen/U FEIBA, wherein said immunotolerant pharmaceutical prothrombin complex preparation does not include fibrinogen and heparin, said method comprising the steps of:

(a) providing a plasma or plasma fraction comprising factors II, IX, X and VII,

(b) contacting said plasma or said plasma fraction with a carrier material so as to separate factor VIII from factors II, IX, X and VII,

(c) purifying said plasma or plasma fraction, and

(d) recovering a fraction comprising factors II, IX, X and VII.

13. A method as set forth in claim 12, wherein said contacting of said plasma or said plasma fraction with said carrier material is effected in the presence of a detergent.

14. A method as set forth in claim 12, wherein phospholipids are also separated when factor VIII is separated from said factors II, IX, X and VII.

15. A method as set forth in claim 9, wherein steps (b) and (c) are carried out in one method step.

16. A method as set forth in claim 12, wherein steps (b) and (c) are carried out in one method step.

17. A method as set forth in claim 9, wherein said carrier material is a material suitable for at least one of chromatography, filtration and nanofiltration.

18. A method as set forth in claim 12, wherein said carrier material is a material suitable for at least one of chromatography, filtration and nanofiltration.

19. A method as set forth in claim 12, wherein said carrier material is a factor VIII specific carrier material.

20. A method as set forth in claim 12, wherein said carrier material is a factor VIII specific carrier material.

21. A method as set forth in claim 19, wherein said factor VIII specific carrier material is a matrix suitable for affinity chromatography.

22. A method as set forth in claim 20, wherein said factor VIII specific carrier material is a matrix suitable for affinity chromatography.

23. A method as set forth in claim 21, wherein said matrix is a vWF-containing matrix.

24. A method as set forth in claim 22, wherein said matrix is a vWF-containing matrix.

25. A method as set forth in claim 9, wherein said factor VIII is adsorbed on said carrier material.

26. A method as set forth in claim 11, wherein said factor VIII and said phospholipids are adsorbed on said carrier material.

27. A method as set forth in claim 12, wherein said factor VIII is adsorbed on said carrier material.

28. A method as set forth in claim 14, wherein said factor VIII and said phospholipids are adsorbed on said carrier material.

29. A method as set forth in claim 9, wherein said carrier material has a higher affinity for the prothrombin complex than for factor VIII.

30. A method as set forth in claim 12, wherein said carrier material has a higher affinity for the prothrombin complex than for factor VIII.

31. A method as set forth in claim 29, wherein said carrier material is a weak anion exchanger.

32. A method as set forth in claim 30, wherein said carrier material is a weak anion exchanger.

33. A method as set forth in claim 29, wherein factors II, IX and X are adsorbed on said carrier material, while factor VIII is eluted.

34. A method as set forth in claim 30, wherein factors II, IX, X and VIII are adsorbed on said carrier material, while factor VIII is eluted.

35. A method as set forth in claim 33, wherein said phospholipids are also separated when factor VIII is separated from said factors II, IX and X, said phospholipids being eluted together with factor VIII.

36. A method as set forth in claim 34, wherein said phospholipids are also separated when factor VIII is separated from said factors II, IX, X and VII, said phospholipids being eluted together with factor VIII.

37. A method as set forth in claim 29, wherein factors II, IX and X are not bound to the carrier material.

38. A method as set forth in claim 30, wherein factors II, IX, X and VII are not bound to the carrier material.

39. A method as set forth in claim 10, wherein said detergent is a non-ionic detergent.

40. A method as set forth in claim 13, wherein said detergent is a non-ionic detergent.

41. A method as set forth in claim 39, wherein said non-ionic detergent is a polyether.

42. A method as set forth in claim 40, wherein said non-ionic detergent is a polyether.

43. A method as set forth in claim 10, further comprising removing said detergent after contact with said plasma or said plasma fraction.

44. A method as set forth in claim 13, further comprising removing said detergent after contact with said plasma or said plasma fraction.

45. A method as set forth in claim 9, wherein said plasma fraction is selected from the group consisting of a product of chromatography, a product of precipitation, a product of centrifugation and a cryoprecipitate supernatant.

46. A method as set forth in claim 12, wherein said plasma fraction is selected from the group consisting of a product of chromatography, a product of precipitation, a product of centrifugation and a cryoprecipitate supernatant.

47. A method as set forth in claim 9, wherein said plasma fraction has at least an intermediary purity.

48. A method as set forth in claim 12, wherein said plasma fraction has at least an intermediary purity.

49. A method as set forth in claim 9, further comprising at least one step for inactivating or depleting viruses or virus components.

50. A method as set forth in claim 12, further comprising at least one step for inactivating or depleting viruses or virus components.

51. A method as set forth in claim 49, wherein said at least one step for inactivating or depleting viruses or virus components is selected from the group consisting of a heat treatment, a vapor treatment, a treatment with a solvent and a treatment with a detergent and nanofiltration.

52. A method as set forth in claim 50, wherein said at least one step for inactivating or depleting viruses or virus components is selected from the group consisting of a heat treatment, a vapor treatment, a treatment with a solvent and a treatment with a detergent and nanofiltration.

53. A preparation as set forth in claim 1, obtainable by

(a) providing a plasma or a plasma fraction comprising factors II, IX and X,

(b) contacting said plasma or said plasma fraction with a carrier material so as to separate factor VIII from factors II, IX and X,

(c) purifying said plasma or plasma fraction, and

(d) recovering a fraction comprising factors II, IX and X.

54. A preparation as set forth in claim 1, obtainable by

(a) providing a plasma or a plasma fraction comprising factors II, IX, X and VII,

(b) contacting said plasma or said plasma fraction with a carrier material so as to separate factor VIII from factors II, IX, X and VII,

(c) purifying said plasma or plasma fraction, and

(d) recovering a fraction comprising factors II, IX, X and VII.

55. A method for treating hemophilia A patients, said method comprising administering to said patients an effective amount of an immunotolerant pharmaceutical prothrombin complex preparation comprising factors II, IX and X, and having a factor VIII antigen content of less than 0.1 factor VIII:C antigen/U FEIBA.

56. A method for treating hemophilia A patients, said method comprising administering to said patients an effective amount of an immunotolerant pharmaceutical prothrombin complex preparation comprising factors II, IX, X and VII, and having a factor VIII antigen content of less than 0.1 factor VIII:C antigen/U FEIBA.

57. A method as set forth in claim 55, wherein said patients have an inhibitor titer of greater than 1 Bethesda U/ml plasma.

58. A method as set forth in claim 56, wherein said patients have an inhibitor titer of greater than 1 Bethesda U/ml plasma.

59. A method as set forth in claim 55, wherein said patients have an inhibitor titer of greater than 5 Bethesda U/ml plasma.

60. A method as set forth in claim 56, wherein said patients have an inhibitor titer of greater than 5 Bethesda U/ml plasma.

Details for Patent 6,358,534

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Baxalta Us Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 12/21/1979 ⤷  Try a Trial 2017-04-08
Baxalta Us Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 07/31/2000 ⤷  Try a Trial 2017-04-08
Baxalta Us Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 08/11/2005 ⤷  Try a Trial 2017-04-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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