Claims for Patent: 7,442,371

Summary for Patent: 7,442,371

Title:	Recombinant human albumin-erythropoietin fusion proteins with long-lasting biological effects
Abstract:	Compositions, kits and methods are provided for promoting general health or for prevention or treatment of diseases by using novel recombinant fusion proteins of human serum albumin (HSA) and bioactive molecules. The bioactive molecules may be a protein or peptide having a biological function in vitro or in vivo, and preferably, having a therapeutic activity when administered to a human. By fusing the bioactive molecule to HSA, stability of the bioactive molecule in vivo can be improved and the therapeutic index increased due to reduced toxicity and longer-lasting therapeutic effects in vivo. In addition, manufacturing processes are provided for efficient, cost-effective production of these recombinant proteins in yeast.
Inventor(s):	Yu; Zailin (New York, NY), Fu; Yan (New York, NY)
Assignee:
Application Number:	11/825,686
Patent Claims:	1. A human serum albumin-erythropoietin (HSA-EPO) fusion protein comprising: (a) the amino acid sequence of SEQ ID NO: 6; (b) the amino acid sequence encoded by the polynucleotide, of SEQ ID NO: 5; or (c) the amino acid sequence encoded by the polynucleotide contained in the yeast strain designated as YZ-HSA/hEPO in ATCC .RTM. Deposit No: PTA-4607, said HSA-EPO fusion protein having a plasma half-life longer than a plasma half-life of erythropoietin. 2. The HSA-EPO fusion protein of claim 1, wherein said fusion protein is a human serum albumin-human erythropoietin fusion protein. 3. The HSA-EPO fusion protein of claim 1, wherein said HSA-EPO fusion protein has a shelf-life four times longer than a shelf-life of erythropoietin. 4. The HSA-EPO fusion protein of claim 1, wherein said HSA-EPO fusion protein has said plasma half-life four times longer than said plasma half-life of erythropoietin. 5. A composition comprising said HSA-EPO fusion protein of claim 1 and a pharmaceutically acceptable excipient. 6. The composition of claim 5 further comprising a human serum albumin-human interleukin-11 fusion protein (HSA-IL-11 fusion protein). 7. The composition of claim 5 further comprising a human serum albumin-human interleukin-3 fusion protein (HSA-IL-3 fusion protein).

Details for Patent 7,442,371

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		2022-07-01
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2022-07-01
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2022-07-01
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2022-07-01