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Last Updated: March 28, 2024

Claims for Patent: 6,524,570


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Summary for Patent: 6,524,570
Title: Polyethylene glycol modified interferon therapy
Abstract:A method comprising administering a PEG.sub.12000 -IFN alpha conjugate to an individual afflicted with a viral infection susceptible of treatment with interferon alpha, preferably chronic hepatitis C, is disclosed.
Inventor(s): Glue; Paul (Flemington, NJ), Cutler; David L. (Morristown, NJ), Affrime; Melton B. (Flemington, NJ)
Assignee: Schering Corporation (Kanilworth, NJ)
Application Number:09/699,663
Patent Claims:1. A method of treating a patient suspected of having hepatitis C infection, comprising administering to the patient a conjugate comprising polyethylene glycol (PEG) and an alpha interferon once per week in an amount effective to treat the infection.

2. The method of claim 1 wherein said interferon is interferon alpha-2a.

3. The method of claim 1 wherein said interferon is interferon alpha-2b.

4. The method of claim 1 wherein said interferon comprises consensus alpha interferon.

5. The method of claim 1 wherein said interferon comprises naturally occurring alpha interferon.

6. The method of claim 1 wherein said interferon comprises recombinant alpha interferon.

7. The method of claim 1 wherein the amount of the conjugate administered is 0.5 .mu.g/kg.

8. The method of claim 1 wherein the amount of the conjugate administered is 2.0 .mu.g/kg.

9. The method of claim 1 wherein the amount of the conjugate administered is 0.5, 1.0, or 1.5 .mu.g/kg.

10. The method of claim 1 wherein said PEG is conjugated to said alpha interferon via an epsilon amino group of a lysine residue in said alpha interferon.

11. The method of claim 1 wherein said PEG is conjugated to free amino groups of said alpha interferon via a urethane linkage.

12. A method of treating a patient suspected of having hepatitis C infection, comprising administering to the patient a conjugate comprising polyethylene glycol (PEG) and an alpha interferon once or twice per week in an amount effective to treat the infection.

13. The method of claim 12 wherein said interferon is interferon alpha-2a.

14. The method of claim 12 wherein said interferon is interferon alpha-2b.

15. The method of claim 12 wherein said interferon comprises consensus alpha interferon.

16. The method of claim 12 wherein said interferon comprises naturally occurring alpha interferon.

17. The method of claim 12 wherein said interferon comprises recombinant alpha interferon.

18. The method of claim 12 wherein the amount of the conjugate administered is 0.5 .mu.g/kg.

19. The method of claim 12 wherein the amount of the conjugate administered is 2.0 .mu.g/kg.

20. The method of claim 12 wherein the amount of the conjugate administered is 0.5, 1.0, or 1.5 .mu.g/kg.

21. The method of claim 12 wherein said PEG is conjugated via an epsilon amino group of a lysine residue in said interferon alpha.

22. The method of claim 12 wherein said PEG is conjugated to free amino groups of said interferon alpha via a urethane linkage.

23. The method of claim 12 wherein said conjugate is administered to said patient twice per week.

24. A method of treating a patient suspected of having hepatitis C infection, comprising administering to the patient in combination, ribavirin and a conjugate comprising polyethylene glycol (PEG) and an alpha-interferon, each in amounts effective to treat the infection, wherein the conjugate is administered once or twice per week.

25. The method of claim 24 wherein said interferon is interferon alpha-2a.

26. The method of claim 24 wherein said interferon is interferon alpha-2b.

27. The method of claim 24 wherein said interferon comprises consensus alpha interferon.

28. The method of claim 24 wherein said interferon comprises naturally occurring alpha interferon.

29. The method of claim 24 wherein said interferon comprises recombinant alpha interferon.

30. The method of claim 25 wherein the amount of the conjugate administered is 0.5 .mu.g/kg.

31. The method of claim 25 wherein the amount of the conjugate administered is 2.0 .mu.g/kg.

32. The method of claim 25 wherein the amount of the conjugate administered is 0.5, 1.0, or 1.5 .mu.g/kg.

33. The method of claim 25 wherein said PEG is conjugated to said alpha interferon via an epsilon amino group of a lysine residue in said alpha interferon.

34. The method of claim 25 wherein said PEG is conjugated to free amino groups of said alpha interferon via a urethane linkage.

35. The method of claim 24 wherein the conjugate is administered once per week.

36. The method of claim 24 wherein the conjugate is administered twice per week.

Details for Patent 6,524,570

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Corp. PEGINTRON peginterferon alfa-2b Injection 103949 01/19/2001 ⤷  Try a Trial 2015-11-02
Merck Sharp & Dohme Corp. SYLATRON peginterferon alfa-2b For Injection 103949 03/29/2011 ⤷  Try a Trial 2015-11-02
Hoffmann-la Roche Inc. PEGASYS COPEGUS COMBINATION PACK peginterferon alfa-2a and ribavirin 125083 06/04/2004 ⤷  Try a Trial 2015-11-02
Schering Corporation A Subsidiary Of Merck & Co., Inc. PEGINTRON/ REBETOL COMBO PACK peginterferon alfa-2b and ribavirin 125196 06/13/2008 ⤷  Try a Trial 2015-11-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 6,524,570

Country Patent Number Estimated Expiration
South Africa 983543 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9848840 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9716204 ⤷  Try a Trial
United States of America 6461605 ⤷  Try a Trial
United States of America 6177074 ⤷  Try a Trial
United States of America 5908621 ⤷  Try a Trial
>Country >Patent Number >Estimated Expiration

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