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Last Updated: December 16, 2025

Claims for Patent: 10,030,060

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Summary for Patent: 10,030,060

Title:	Long-acting polypeptides and methods of producing same
Abstract:	A polypeptide and polynucleotides encoding same comprising one carboxy-terminal peptide (CTP) of chorionic gonadotrophin attached to an amino terminus of a cytokine and two carboxy-terminal peptides (CTP) of chorionic gonadotrophin attached to a carboxy terminus of a cytokine are disclosed. Pharmaceutical compositions comprising the polypeptide and polynucleotides of the invention and methods of using same are also disclosed.
Inventor(s):	Fares; Fuad (Hourfish Village, IL), Fima; Udi Eyal (Beer-Sheva, IL)
Assignee:	OPKO Biologics Ltd. (Kiryat Gat, IL)
Application Number:	14/566,370
Patent Claims:	1. A polypeptide consisting of an interferon and optionally a signal peptide, wherein a first chorionic gonadotropin carboxy terminal peptide is attached to the amino terminus of said interferon, and a second and third chorionic gonadotropin carboxy terminal peptide are attached to the carboxy terminus of said interferon, wherein said third chorionic gonadotropin carboxy terminal peptide is attached in tandem to said second chorionic gonadotropin carboxy terminal peptide. 2. The polypeptide of claim 1, wherein the sequence of at least 1 of said chorionic gonadotropin carboxy terminal peptides is an amino acid sequence selected from sequences set forth in SEQ ID NO: 17 and SEQ ID NO: 18. 3. The polypeptide of claim 1, wherein at least 1 of said chorionic gonadotropin carboxy terminal peptides is truncated. 4. The polypeptide of claim 1, wherein said interferon is glycosylated. 5. The polypeptide of claim 1, wherein said interferon is non-glycosylated. 6. The polypeptide of claim 1, wherein at least 1 of said chorionic gonadotropin carboxy terminal peptides is glycosylated. 7. The polypeptide of claim 1, wherein at least 1 of said chorionic gonadotropin carboxy terminal peptides is attached to said interferon via a linker. 8. The polypeptide of claim 1, wherein when said optional signal peptide is present, the amino acid sequence of said signal peptide is set forth in SEQ ID NO: 64. 9. A pharmaceutical formulation comprising the polypeptide of claim 1, wherein said formulation further comprises a buffer, and a tonicity agent. 10. The formulation of claim 9, wherein said buffer is citrate or acetate. 11. The formulation of claim 9, wherein said tonicity agent is sodium chloride. 12. The formulation of claim 9, wherein said formulation is formulated for injection in a multidose container, with optionally, a preservative. 13. The formulation of claim 12, wherein said preservative is benzalkonium chloride or thimerosal. 14. A liquid formulation, comprising the formulation of claim 13. 15. The polypeptide of claim 1, wherein when said second and third chorionic gonadotropin carboxy terminal peptide are attached to said carboxy terminus, the amino acid sequence of said polypeptide is set forth in amino acids 22-271 of SEQ ID NO: 56. 16. A method of extending the biological half-life of an interferon, comprising attaching two or three chorionic gonadotropin carboxy terminal peptides to said interferon, wherein a first chorionic gonadotropin carboxy terminal peptide is attached to an amino terminus of said interferon, and either only a second chorionic gonadotropin carboxy terminal peptide is attached to the carboxy terminus of said interferon or two chorionic gonadotropin carboxy terminal peptides are attached to a carboxy terminus of said interferon, thereby extending the biological half-life of said interferon.

Details for Patent 10,030,060

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	10,030,060	2034-12-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	10,030,060	2034-12-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	10,030,060	2034-12-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	10,030,060	2034-12-10
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974	10,030,060	2034-12-10
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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