Claims for Patent: 7,435,410

Summary for Patent: 7,435,410

Title:	Methods of treatment with interferson and albumin fusion protein
Abstract:	Biologically active polypeptides comprising a therapeutically active polypeptide fused to human serum albumin or a variant thereof, methods for the preparation thereof, nucleotide sequences encoding such fusion polypeptides, expression cassettes comprising such nucleotide sequences, self-replicating plasmids containing such expression cassettes, and pharmaceutical compositions containing said fusion polypeptides.
Inventor(s):	Fleer; Reinhard (Bures-sur-Yvette, FR), Fournier; Alain (Chatenay-Malabry, FR), Guitton; Jean-Dominique (Paris, FR), Jung; Gerard (Leuville-sur-Orge, FR), Yeh; Patrice (Paris, FR)
Assignee:	Novozymes Biopharma UK Limited (Nottingham, GB)
Application Number:	11/146,077
Patent Claims:	1. A method of treating a patient in need of interferon, comprising the step of administering to said patient a fusion protein comprising interferon and albumin or an albumin variant, wherein (i) said fusion protein has a higher plasma stability than unfused interferon, (ii) said albumin or albumin variant is located either at the N-terminus or C-terminus of said fusion protein, and (iii) said fusion protein retains the therapeutic activity of unfused interferon. 2. The method of claim 1, wherein said fusion protein comprises albumin. 3. The method of claim 1, wherein said fusion protein comprises an albumin variant. 4. The method of claim 3, wherein said albumin variant is a fragment of albumin. 5. The method of claim 3, wherein said albumin variant has a mutation of one or more residues. 6. The method of claim 3, wherein said albumin variant has a deletion of one or more residues. 7. The method of claim 3, wherein said albumin variant has a mutation and a deletion of one or more residues. 8. The method of claim 3, wherein said albumin variant has an addition of one or more residues. 9. The method of claim 1, wherein said fusion protein comprises an N-terminal methionine. 10. The method of claim 1, wherein said fusion protein comprises a peptide linker. 11. The method of claim 1, wherein said fusion protein comprises a secretion signal sequence. 12. The method of claim 11, wherein said secretion signal sequence is the natural leader sequence of interferon. 13. The method of claim 3, wherein said interferon is fused to the N-terminal end of said albumin or albumin variant. 14. The method of claim 3, wherein said interferon is fused to the C-terminal end of said albumin or albumin variant. 15. A method of treating a patient in need of interferon, comprising the step of administering to said patient a fusion protein comprising interferon and a mature form of albumin, wherein (i) said fusion protein has a higher plasma stability than unf used interferon, (ii) said mature form of albumin is located either at the N-terminus or C-terminus of said fusion protein, and (iii) said fusion protein retains the therapeutic activity of unfused interferon. 16. The method of claim 15, wherein said fusion protein comprises an N-terminal methionine. 17. The method of claim 15, wherein said fusion protein comprises a peptide linker. 18. The method of claim 15, wherein said fusion protein comprises a secretion signal sequence. 19. The method of claim 18, wherein said secretion signal sequence is the natural leader sequence of interferon. 20. The method of claim 15, wherein said interferon is fused to the N-terminal end of said mature form of albumin. 21. The method of claim 20, wherein said fusion protein comprises an N-terminal methionine. 22. The method of claim 20, wherein said fusion protein comprises a peptide linker. 23. The method of claim 20, wherein said fusion protein comprises a secretion signal sequence. 24. The method of claim 23, wherein said secretion signal sequence is the natural leader sequence of interferon. 25. The method of claim 15, wherein said interferon is fused to the C-terminal end of said mature form of albumin. 26. The method of claim 25, wherein said fusion protein comprises an N-terminal methionine. 27. The method of claim 25, wherein said fusion protein comprises a peptide linker. 28. The method of claim 25, wherein said fusion protein comprises a secretion signal sequence. 29. The method of claim 28, wherein said secretion signal sequence is the natural leader sequence of interferon. 30. The method of claim 3, wherein said interferon is human interferon, and said albumin or an albumin variant is human albumin or a human albumin variant. 31. The method of claim 15, wherein said interferon is human interferon, and said mature form of albumin is mature form of human albumin.

Details for Patent 7,435,410

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2012-01-31
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2012-01-31
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2012-01-31
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2012-01-31