Claims for Patent: 7,615,532

Summary for Patent: 7,615,532

Title:	Insulin derivatives
Abstract:	The present invention relates to insulin derivatives which are naturally occurring insulins or analogues thereof which have a side chain attached either to the .alpha.-amino group of the N-terminal amino acid residue of the B chain or to the .epsilon.-amino group of a Lys residue present in the B chain of the parent insulin, the side chain being of the general formula: -W-X--Y-Z wherein W, X, Y and Z are as defined in the disclosure.
Inventor(s):	Jonassen; Ib (Valby, DK), Hoeg-Jensen; Thomas (Klampenborg, DK), Havelund; Svend (Bagsv.ae butted.rd, DK), Ribel-Madsen; Ulla (Virum, DK), Tagmose; Tina Moller (Ballerup, DK), Madsen; Peter (Bagsv.ae butted.rd, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DE)
Application Number:	11/343,005
Patent Claims:	1. An insulin derivative which is a naturally occurring insulin or an analogue thereof which has a side chain attached to the .alpha.-amino group of the N-terminal amino acid residue of the B chain or to the .epsilon.-amino group of a Lys residue present in the B chain of the parent insulin, the side chain being of the general formula: -W-X--Y-Z wherein W is: an .alpha.-amino acid residue having a carboxylic acid group in the side chain which amino acid is selected from the group consisting of .alpha.-Asp, .beta.-Asp, .alpha.-Glu, .gamma.-Glu, .alpha.-hGlu and .delta.-hGlu and which residue forms, with one of its carboxylic acid groups, an amide group together with the .alpha.-amino group of the N-terminal amino acid residue of the B chain or together with the .epsilon.-amino group of a Lys residue present in the B chain of the parent insulin; X is: --CO--; Y is: --(CH.sub.2).sub.m-- where m is an integer in the range of 6 to 32; Z is: --COOH; and any Zn.sup.2+ complexes thereof. 2. An insulin derivative according to claim 1, wherein side chain -W-X--Y-Z is attached to the .epsilon.-amino group of a Lys residue present in the B chain of the parent insulin. 3. An insulin derivative according to claim 1, wherein Y is --(CH.sub.2).sub.m-- where m is an integer in the range of from 12-16. 4. An insulin derivative according to claim 1, wherein the parent insulin is; des(B30) human insulin. 5. An insulin derivative according to claim 1, wherein the insulin derivative is N.sup..epsilon.B29--(N.sup..alpha.--(HOOC(CH.sub.2).sub.14CO)-.gamma.-Glu- ) des(B30) human insulin. 6. A zinc complex of an insulin derivative according to claim 1, wherein each insulin hexamer in said complex binds two zinc ions. 7. A zinc complex of an insulin derivative according to claim 1, wherein each insulin hexamer in said complex binds three zinc ions. 8. A zinc complex of an insulin derivative according to claim 1, wherein each insulin hexamer in said complex binds four zinc ions. 9. A pharmaceutical composition for the treatment of diabetes in a patient in need of such treatment, said composition comprising a therapeutically effective amount of an insulin derivative according to claim 1 together with a pharmaceutically acceptable carrier. 10. A pharmaceutical composition for the treatment of diabetes in a patient in need of such treatment, said composition comprising a therapeutically effective amount of an insulin derivative according to claim 1 in mixture with an insulin or an insulin analogue which has a rapid onset of action, together with a pharmaceutically acceptable carrier. 11. A pharmaceutical composition for the treatment of diabetes in a patient in need of such treatment, said composition comprising a therapeutically effective amount of an insulin derivative with a pharmaceutically acceptable carrier, wherein said insulin derivative is N.sup..epsilon.B29--(N.sup..alpha.--(HOOC(CH.sub.2).sub.14CO)-.gamma.-Glu- ) des(B30) human insulin. 12. A pharmaceutical composition for the treatment of diabetes in a patient in need of such treatment, said composition comprising a therapeutically effective amount of an insulin derivative in mixture with an insulin or an insulin analogue which has a rapid onset of action, together with a pharmaceutically acceptable carrier, wherein said insulin derivative is N.sup..epsilon.B29--(N.sup..alpha.--(HOOC(CH.sub.2).sub.14CO)--.gamma.-Gl- u) des(B30) human insulin.

Details for Patent 7,615,532

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	September 25, 2015		2023-08-05
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	September 25, 2015		2023-08-05
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	November 21, 2018		2023-08-05

International Patent Family for US Patent 7,615,532

Country	Patent Number	Estimated Expiration
South Africa	200600846
World Intellectual Property Organization (WIPO)	2005012347
United States of America	8828923
United States of America	2014349925
United States of America	2010009899