	US 12,274,737 B2
	PEGylated recombinant human growth hormone compounds
Harald Rau, Dossenheim (DE); Susanne Kindermann, Liestal (CH); Torben Leßmann, Neustadt an der Weinstrasse (DE); Grethe Norskov Rasmussen, Farum (DK); Ulrich Hersel, Heidelberg (DE); Thomas Wegge, Heidelberg (DE); and Kennett Sprogøe, Holte (DK)
Assigned to Ascendis Pharma Endocrinology Division A/S, Hellerup (DK)
Filed by Ascendis Pharma Endocrinology Division A/S, Hellerup (DK)
Filed on Mar. 29, 2021, as Appl. No. 17/215,991.
Application 17/215,991 is a continuation of application No. 16/146,253, filed on Sep. 28, 2018, granted, now 10,960,053.
Application 16/146,253 is a continuation of application No. 15/000,242, filed on Jan. 19, 2016, granted, now 10,098,930.
Application 15/000,242 is a continuation of application No. 12/990,101, granted, now 9,272,048, previously published as PCT/EP2009/055194, filed on Apr. 29, 2009.
Claims priority of application No. 08155408 (EP), filed on Apr. 29, 2008; application No. 08162865 (EP), filed on Aug. 22, 2008; and application No. 08167289 (EP), filed on Oct. 22, 2008.
Prior Publication US 2021/0220442 A1, Jul. 22, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/27 (2006.01); A61K 47/60 (2017.01); A61K 47/65 (2017.01); C07K 14/61 (2006.01)

CPC A61K 38/27 (2013.01) [A61K 47/60 (2017.08); A61K 47/65 (2017.08); C07K 14/61 (2013.01)]

18 Claims

1. A method of treating a growth hormone (GH) related disease, wherein the method comprises administering once weekly an effective amount of a prodrug conjugate of the human growth hormone (hGH) to a patient having a GH related disease and wherein the prodrug conjugate of the human growth hormone (hGH) is of formula (AA)

hGH-NH-L^a-S⁰ (AA),

wherein

hGH-NH represents the hGH residue;

L^arepresents a functional group, which is self hydrolysable (auto-cleavable) by an auto-cleavage inducing group Ga; and

S⁰is a polymer chain having a molecular weight of at least 5 kDa and comprising an at least first branching structure BS¹, the at least first branching structure BS¹comprising an at least second polymer chain S¹having a molecular weight of at least 4 kDa, wherein at least one of S⁰, BS¹, S¹further comprises the auto-cleavage inducing group G^aand wherein the branching structure BS¹further comprises an at least third polymer chain S²having a molecular weight of at least 4 kDa or at least one of S⁰, S¹comprises an at least second branching structure B S 2 comprising the at least third polymer chain S²having a molecular weight of at least 4 kDa and wherein the molecular weight of the prodrug conjugate without the hGH-NH is at least 25 kDa and at most 1000 kDa.