Claims for Patent: 5,639,639

Summary for Patent: 5,639,639

Title:	Recombinant heterodimeric human fertility hormones, and methods, cells, vectors and DNA for the production thereof
Abstract:	Biologically active heterodimeric human fertility hormones composed of two different subunits, each subunit being synthesized in the same cell transformed by at least one cell expression vector having heterologous DNA encoding each subunit with each subunit being controlled by a separate promoter. Preferred human fertility hormones include hCG, hLH and hFSH.
Inventor(s):	Reddy; Vermuri B. (Westboro, MA), Hsiung; Nancy (Wellesley, MA), Beck; Anton K. (Pfeffiagen, CH), Bemstine; Edward George (Boston, MA)
Assignee:	Genzyme Corporation (Boston, MA)
Application Number:	08/268,734
Patent Claims:	1. A process for producing biologically active heterodimeric human fertility hormone selected from the group consisting of human chorionic gonadotropin, human luteinizing hormone and human follicle stimulating hormone, comprising: transforming a eukaryotic cell with at least one vector constructed so as to insert into said cell DNA coding for each of the two subunits of the hormone, the translation of the DNA of each said subunit being controlled by a separate promoter; and culturing said cell under conditions appropriate to permit expression of the hormone therefrom, wherein said eukaryotic cell is one which permits appropriate post-translational modification of the subunits so produced such that the formed protein is biologically active. 2. A process in accordance with claim 1, wherein said hormone is human chorionic gonadotropin. 3. A process in accordance with claim 1, wherein said hormone is human luteinizing hormone. 4. A process in accordance with claim 1, wherein said hormone is human follicle stimulating hormone. 5. A process in accordance with claim 1, wherein said transforming step comprises transforming the cell with a single vector containing DNA for both of said subunits under the control of separate promoters. 6. A process in accordance claim 1, wherein said transforming step comprises transforming the cell with two vectors each containing DNA for one of said subunits and an appropriate promoter. 7. A process in accordance with claim 1, wherein said at least one vector is autonomously replicating. 8. A process in accordance with claim 1, wherein said at least one vector is a plasmid or a replicating virus. 9. A process in accordance with claim 1, wherein each of said promoters are different. 10. A eukaryotic cell transformed by at least one vector constructed so as to insert into said cell heterologous DNA coding for each of the two subunits of a heterodimeric human fertility hormone selected from the group consisting of human chorionic gonadotropin, human luteinizing hormone and human follicle stimulating hormone, the translation of the DNA of each said subunit being controlled by a separate promoter, said eukaryotic cell being of a species which permits appropriate post-translational modification of the subunits so produced such that the formed protein is biologically active. 11. A cell in accordance with claim 10, wherein said hormone is human chorionic gonadotropin. 12. A cell in accordance with claim 10, wherein said hormone is human luteinizing hormone. 13. A cell in accordance with claim 10, wherein said hormone is human follicle stimulating hormone. 14. A cell in accordance with claim 10, wherein the cell has been transformed with a single vector containing DNA for both of said subunits under the control of separate promoters. 15. A cell in accordance with claim 10, wherein the cell has been transformed with two vectors each containing DNA for one of said subunits and an appropriate promoter. 16. A cell in accordance with claim 10, wherein said at least one vector is autonomously replicating. 17. A cell in accordance with claim 10, wherein said at least one vector is a plasmid or a replicating virus. 18. A cell in accordance with claim 10, wherein each of said promoters are different. 19. An expression vector containing DNA encoding each of the two subunits of a heterodimeric human fertility hormone selected from the group consisting of human chorionic gonadotropin, human luteinizing hormone and human follicle stimulating hormone, with separate promoters for each said subunit. 20. An expression vector in accordance with claim 19, wherein said hormone is human chorionic gonadotropin. 21. An expression vector in accordance with claim 19, wherein said hormone is human luteinizing hormone. 22. An expression vector in accordance with claim 19, wherein said hormone is human follicle stimulating hormone. 23. An expression vector in accordance with claim 19, wherein each said promoter is different. 24. An expression vector in accordance with claim 23, wherein said two different promoters are derived from two different species. 25. An expression vector in accordance with claim 19, which is autonomously replicating. 26. An expression vector in accordance with claim 19 comprising a plasmid or a replicating virus.

Details for Patent 5,639,639

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974		2003-11-02
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984		2003-11-02
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985		2003-11-02
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990		2003-11-02
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974		2003-11-02
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	March 05, 1973		2003-11-02