Claims for Patent: 6,441,145

Summary for Patent: 6,441,145

Title:	Transgenically produced Antithrombin III
Abstract:	This invention relates to transgenically produced human Antithrombin III (tgATIII). The human ATIII produced by the transgenic process of the present invention has a monosaccharide composition which comprises N-acetylgalactosamine (GaINAc) along with fucose, N-acetylglucosamine, galactose, mannose, and N-acetylneuraminic acid/N-glycolyneuraminic acid. The monosaccharide composition differs with that of plasma derived ATIII (phATIII). It has been found that tgATIII has an increased clearance rate when compared to phATIII.
Inventor(s):	DiTullio; Paul (Framingham, MA), Meade; Harry (Newton, MA), Cole; Edward S. (Mendon, MA)
Assignee:	Genzyme Transgenics, Inc. (Framingham, MA)
Application Number:	09/143,155
Patent Claims:	1. Mammary gland produced antithrombin III having a monosaccharide composition which comprises GalNAc. 2. Mammary gland produced antithrombin III having a monosaccharide composition which comprises fucose. 3. Mammary gland produced antithrombin III having a monosaccharide composition which comprises a higher level of mannose than plasma derived antithrombin III. 4. The mammary gland produced antithrombin III of claim 1 further comprising fucose. 5. The mammary gland produced antithrombin III of claims 1, 2, or 4 wherein the antithrombin III further comprises a higher level of mannose than plasma derived antithrombin III. 6. The mammary gland produced antithrombin III of claim 1, 2, 3, or 4 wherein the antithrombin III is produced in the mammary glands of a transiemc goat. 7. A method for producing antithrombin III in mammalian milk, comprising: a. providing a transgenic mammal that expresses in its mammary tissue a transgene which encodes a human antithrombin III with a monosaccharide composition which comprises GalNAc, wherein said human antithrombin III is secreted into the milk of the mammal; and b. collecting milk from the transgenic animal which contains the human antithrombin III; c. to thereby obtain human antithrombin III with a monosaccharide composition which includes GalNAc. 8. The method of claim 7, further comprising isolating human ATIII from the milk. 9. The method of claim 7, wherein the transgenic mammal is goat. 10. The method of claim 7, wherein the transgenic mammal is a mouse. 11. A glycosylated human antithrombin III which is produced in mammary gland of a non-human transgenic mammal, wherein the antithrombin III comprises a monosaccharide composition which comprises GalNAc. 12. A glycosylated human antithrombin III which is produced in the mammary gland of a non-human transgenic mammal, wherein the antithrombin III comprises a monosaccharide composition which comprises fucose. 13. A glycosylated human antithrombin III which is produced in the mammary gland of a non-human transgenic mammal, wherein the antithrombin III comprises a monosaccharide composition which comprises a higher level of mannose than plasma derived antithrombin III. 14. The glycosylated human antithrombin III of claim 13 wherein the antithrombin III has a higher affinity for heparin binding as compared to plasma derived antithrombin III. 15. A method for producing antithrombin III in mammalian milk, comprising: providing a transgenic mammal that expresses in its mammary tissue a transgene which encodes a human antithrombin III with a monosaccharide composition which comprises fucose, wherein said human antithrombin III is secreted into the milk of the mammal; and collecting milk from the transgenic animal which contains the human antithrombin III to thereby obtain human antithrombin III with a monosaccharide composition which includes fucose. 16. The method of claim 15, wherein the transgenic mammal is a goat. 17. The method of claim 15, wherein the transgenic mammal is a mouse. 18. A method for producing antithrombin III in mammalian milk, comprising: providing a transgenic mammal that expresses in its mammary tissue a transgene which encodes a human antithrombin III having a monosaccharide composition which comprises a higher level of mannose than plasma derived antithrombin III, wherein said human antithrombin III is secreted into the milk,of the mammal; and collecting milk from the transgenic animal which contains the human antithrombin III to thereby obtain human antithrombin III having a monosaccharide composition which includes a higher level of mannose than plasma derived antithrombin III. 19. The method of claim 18, wherein the transgenic mammal is a goat. 20. The method of claim 18, wherein the transgenic mammal is a mouse.

Details for Patent 6,441,145

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	THROMBATE III	antithrombin iii (human)	For Injection	103196	12/30/1991		2015-02-21